42 results on '"Shukla VV"'
Search Results
2. Prediction of early oral feeding achievement in preterm infants
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Shukla, VV, primary, Gentle, SJ, additional, Cooley, A, additional, Singh, A, additional, Ambalavanan, N, additional, Carlo, WA, additional, and Salas, A, additional
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- 2023
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3. The association between maternal race/ethnicity and education level with infant mortality rates by gestational age
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Goldman, JC, primary, Watt, MJ, additional, Trulove, SG, additional, Tindal, R, additional, Shukla, VV, additional, Carlo, WA, additional, and Travers, C, additional
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- 2023
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4. 600 - Prediction of early oral feeding achievement in preterm infants
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Shukla, VV, Gentle, SJ, Cooley, A, Singh, A, Ambalavanan, N, Carlo, WA, and Salas, A
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- 2023
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5. 505 - The association between maternal race/ethnicity and education level with infant mortality rates by gestational age
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Goldman, JC, Watt, MJ, Trulove, SG, Tindal, R, Shukla, VV, Carlo, WA, and Travers, C
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- 2023
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6. 467 - Early fluid status and prediction of severe intraventricular hemorrhage or death in extremely preterm infants
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Weaver, L, Gentle, SJ, Shukla, VV, Nakhmani, A, Rahman, F, Ambalavanan, N, Askenazi, DJ, and Travers, C
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- 2023
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7. A Tool to Help Nurses Provide Health Education on Adverse Pregnancy Outcomes and Cardiovascular Health.
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Rattan J, Richardson MB, Toluhi AA, Budhwani H, Shukla VV, Travers CP, Steen J, Wingate M, Tita A, Turan JM, Carlo WA, and Sinkey R
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Adverse pregnancy outcomes are associated with poor short- and long-term cardiovascular health. However, patients and their health care providers may not have knowledge of this risk or of the healthful practices that can reduce this risk. Childbirth care can be a pivotal time in the patient-clinician relationship to build awareness and spur prevention planning. As part of the American Heart Association-supported program entitled Providing an Optimized and Empowered Pregnancy for You (P
3 OPPY), our team collaborated with a community advisory board to create a teaching handout about adverse pregnancy outcomes for incorporation into hospital-based postpartum care. This handout can be used by pregnancy and maternity care providers, including postpartum nurses, to provide health education on how adverse pregnancy outcomes can influence risk for future cardiovascular disease and what can be done for prevention., (Copyright © 2024 AWHONN. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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8. Cerebral injury and retinopathy as risk factors for blindness in extremely preterm infants.
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Honan BM, McDonald SA, Travers CP, Shukla VV, Ambalavanan N, Cotten CM, Jain VG, Arnold HE, Parikh NA, Tyson JE, Hintz SR, Walker SA, Gantz MG, Das A, and Carlo WA
- Abstract
Objective: This study investigates whether and to what extent cerebral injury is associated with bilateral blindness in extremely preterm infants, which has been attributed mainly to retinopathy of prematurity (ROP)., Design: Multicentre analysis of children born from 1994 to 2021 at gestational age 22 0/7 to 28 6/7 weeks with follow-up at 18-26 months. Logistic regression examined the adjusted association of bilateral blindness with severe ROP and/or cerebral injury among extremely preterm infants., Exposures: Severe ROP and cerebral injury, the latter defined as any of the following on cranial imaging: ventriculomegaly; blood/increased echogenicity in the parenchyma; cystic periventricular leukomalacia., Main Outcome Measures: Bilateral blindness, defined as a follow-up examination meeting criteria of 'blind-some functional vision' or 'blind-no useful vision' in both eyes., Results: The 19 863 children included had a mean gestational age of 25.6±1.7 weeks, mean birth weight of 782±158 g and 213 (1%) had bilateral blindness. Multiplicative interaction between ROP and cerebral injury was statistically significant. For infants with only severe ROP (n=3130), odds of blindness were 8.14 times higher (95% CI 4.52 to 14.65), and for those with only cerebral injury (n=2836), odds were 8.38 times higher (95% CI 5.28 to 13.28), compared with the reference group without either condition. Risks were not synergistic for infants with both severe ROP and cerebral injury (n=1438, adjusted OR=28.7, 95% CI 16.0 to 51.7, p<0.0001)., Conclusions: In a group of extremely preterm infants, severe ROP and cerebral injury were equally important risk factors for blindness. Besides ROP, clinicians should consider cerebral injury as a cause of blindness in children born extremely preterm., Trial Registration Number: NCT00063063., Competing Interests: Competing interests: NA is an advisor to ResBiotic and Alveolus Bio and serves on the Data and Safety Monitoring Board for Shire/Oak Hill Bio. CMC has a consulting agreement with ReAlta Life Sciences (for a new drug in clinical trials for hypoxic ischaemic encephalopathy), and IP in a company, CryoCell (for a cell therapy for HIE). AD has a grant from the Neonatal Research Network (NRN). CPT is supported by grants from the National Institutes of Health (K23HL157618). CPT is supported by a grant from Owlet Baby Care for an investigator-initiated study (ClinicalTrials.gov identifier: NCT05774470) and also has a patent application pending for a bradycardia predictor and interrupter. VVS is supported by a grant from the American Heart Association (23CDA1048106)., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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9. When HIPAA hurts: legal barriers to texting may reinforce healthcare disparities and disenfranchise vulnerable patients.
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Lindsey D, Sinkey R, Travers C, Budhwani H, Richardson M, Quinney R, Turan JM, Wallace E, Wingate MS, Tita A, Carlo WA, and Shukla VV
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Effective health communication between healthcare providers and patients is a cornerstone of quality healthcare. It underpins trust, comprehension, and patient-informed care. Robust research shows that effective communication, including the use of text messaging for communication can improve maternal/fetal and neonatal outcomes and patient satisfaction, particularly among vulnerable patients. Health information privacy laws that do not evolve with technological advances can inadvertently create barriers to effective health communication, reinforcing perinatal disparities. This is particularly true regarding maternal and child health, where the use of text messaging for patient communication has the potential to make a substantial impact on health disparities. This article explores the complex interplay between health information privacy laws and text messaging, highlighting challenges and examining potential solutions. It stresses the need for consistent health information privacy laws that protect the privacy security of health information for pregnant patients and new mothers, while also aligning with evolving communication technologies., (© 2024. The Author(s).)
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- 2024
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10. Heart rate characteristics predict risk of mortality in preterm infants in low and high target oxygen saturation ranges.
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King WE, Sanghvi UJ, Ambalavanan N, Shukla VV, Travers CP, Schelonka RL, Wright C, and Carlo WA
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Background: The Neonatal Oxygenation Prospective Meta-analysis found that in infants <28 weeks gestational age, targeting an oxygen saturation ( S
pO ) range of 85-89% versus 91-95% resulted in lower rates of retinopathy of prematurity but increased mortality. We aimed to evaluate the accuracy of the heart rate characteristics index (HRCi) in assessing the dynamic risk of mortality among infants managed with low and high target S2 pO ranges., Methods: We linked the SUPPORT and HRCi datasets from one centre in which the randomised controlled trials overlapped. We examined the maximum daily HRCi (MaxHRCi24) to predict mortality among patients randomised to the lower and higher target S2 pO groups by generating predictiveness curves and calculating model performance metrics, including area under the receiver operating characteristics curve (AUROC) at prediction windows from 1-60 days. Cox proportional hazards models tested whether MaxHRCi24 was an independent predictor of mortality. We also conducted a moderation analysis., Results: There were 84 infants in the merged dataset. MaxHRCi24 predicted mortality in infants randomised to the lower target S2 pO (AUROC of 0.79-0.89 depending upon the prediction window) and higher target S2 pO (AUROC 0.82-0.91). MaxHRCi24 was an important additional predictor of mortality in multivariable modelling. In moderation analysis, in a model that also included demographic predictor variables, the individual terms and the interaction term between MaxHRCi24 and target S2 pO range all predicted mortality., Conclusions: Associations between HRCi and mortality, at low and high S2 pO target ranges, suggest that future research may find HRCi metrics helpful to individually optimise target oxygen saturation ranges for hospitalised preterm infants., Competing Interests: Conflict of interest: W.E. King is a board member, shareholder and employee of Medical Predictive Science Corporation (MPSC), and is a co-inventor of pending patents owned by MPSC. U.J. Sanghvi has received consulting fees from MPSC and is a co-inventor of pending patents owned by MPSC. N. Ambalavanan is supported by grants from the National Institutes of Health (NIH), has participated on data safety monitoring boards by Shire and Oak Hill Bio, has received consulting fees from Radiometer and Provepharm, is an inventor of patents and pending patents owned by Airway Probiotics and Let-7b, respectively, and has stock options from ResBiotic and Alveolus Bio. V.V. Shukla is supported by a grant from the American Heart Association (23CDA1048106). C.P. Travers is supported a grant from the NIH (K23HL157618). R.L. Schelonka declares no conflicts. C. Wright is supported by grants from the NIH (R01HD107700 and R01HL13294), has received payment for expert testimony from the State of Texas, Sommers Schwartz and Dickie McCamey to his institution, and has received consulting fees from Chiesi. W.A. Carlo is supported by grants from the NIH. The funding agencies had no role in the study design; the collection, analysis and interpretation of data; the writing of the report; or the decision to submit the manuscript for publication., (Copyright ©The authors 2024.)2 - Published
- 2024
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11. Social Distancing During the COVID-19 Pandemic and Neonatal Mortality in the US.
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Shukla VV, Weaver LJ, Singh A, Rahman AKMF, Nakhmani A, Travers CP, Sinkey R, Arora N, Ambalavanan N, and Carlo WA
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- Humans, Infant, Newborn, United States epidemiology, Female, Infant, Pandemics, Adult, Male, Cohort Studies, Pregnancy, COVID-19 mortality, COVID-19 epidemiology, Infant Mortality trends, SARS-CoV-2, Physical Distancing
- Abstract
Importance: Neonatal mortality is a major public health concern that was potentially impacted by the COVID-19 pandemic. To prepare for future health crises, it is important to investigate whether COVID-19 pandemic-related interventions were associated with changes in neonatal mortality., Objective: To investigate whether social distancing during the pandemic was associated with a higher neonatal mortality rate., Design, Setting, and Participants: This cohort study examined maternal-linked birth and infant death records from the National Center for Health Statistics, a population-level US database, from 2016 through 2020. The mortality rates were correlated using machine learning-based autoregressive integrated moving average (ARIMA) models with the social distancing index (SDI). The reference period was January 2016 through February 2020, and the pandemic period was March through December 2020. Statistical analysis was performed from March 2023 to May 2024., Exposures: SDI, computed from 6 mobility metrics., Main Outcomes and Measures: The primary outcome was neonatal mortality rate, defined as death at age less than 28 days., Results: The study included 18 011 173 births, of which 15 136 596 were from the reference period (7 753 555 [51.22%] male; 11 643 094 [76.92%] with maternal age of 20 to 34 years) and 2 874 577 were from the pandemic period (1 472 539 [51.23%] male; 2 190 158 [76.19%] with maternal age of 20 to 34 years). Through ARIMA-adjusted analyses, accounting for the declining mortality trend in the reference period, the mortality rates during the pandemic period did not significantly differ from the expected rates. SDI did not exhibit significant correlations with neonatal mortality (unadjusted: correlation coefficient [CC], 0.14 [95% CI, -0.53 to 0.70]; ARIMA adjusted: CC, 0.29 [95% CI, -0.41 to 0.77]), early neonatal mortality (unadjusted: CC, 0.33 [95% CI, -0.37 to 0.79]; ARIMA adjusted: CC, 0.45 [95% CI, -0.24 to 0.84]), and infant mortality (unadjusted: CC, -0.09 [95% CI, -0.68 to 0.57]; ARIMA adjusted: CC, 0.35 [95% CI, -0.35 to 0.80]). However, lag analyses found that SDI was associated with higher neonatal and early neonatal mortality rates with a 2-month lag period, but not with infant mortality rate. SDI was also associated with increases in 22-to-27 weeks' and 28-to-32 weeks' preterm delivery with a 1-month lag period., Conclusions and Relevance: In this population-level study of National Center for Health Statistics databases, neonatal, early neonatal, and infant mortality rates did not increase during the initial COVID-19 pandemic period. However, associations were observed between the pandemic period social distancing measures and higher rates of neonatal and early neonatal mortality, as well as preterm birth rate with a lag period, suggesting the importance of monitoring infant health outcomes following pandemic-related population behavior changes.
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- 2024
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12. Social distancing and extremely preterm births in the initial COVID-19 pandemic period.
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Shukla VV, Carper BA, Ambalavanan N, Rysavy MA, Bell EF, Das A, Patel RM, D'Angio CT, Watterberg KL, Cotten CM, Merhar SL, Wyckoff MH, Sánchez PJ, Kumbhat N, and Carlo WA
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- Humans, Female, Pregnancy, Prospective Studies, Infant, Newborn, Premature Birth epidemiology, Stillbirth epidemiology, United States epidemiology, Incidence, COVID-19 prevention & control, COVID-19 epidemiology, Infant, Extremely Premature, Physical Distancing, Gestational Age, SARS-CoV-2
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Hypothesis: Increased social distancing was associated with a lower incidence of extremely preterm live births (EPLB) during the initial COVID-19 pandemic period., Study Design: Prospective study at the NICHD Neonatal Research Network sites comparing EPLB (22
0/7 -286/7 weeks) and extremely preterm intrapartum stillbirths (EPIS) rates during the pandemic period (March-July, weeks 9-30 of 2020) with the reference period (same weeks in 2018 and 2019), correlating with state-specific social distancing index (SDI)., Results: EPLB and EPIS percentages did not significantly decrease (1.58-1.45%, p = 0.07, and 0.08-0.06%, p = 0.14, respectively). SDI was not significantly correlated with percent change of EPLB (CC = 0.29, 95% CI = -0.12, 0.71) or EPIS (CC = -0.23, 95% CI = -0.65, 0.18). Percent change in mean gestational age was positively correlated with SDI (CC = 0.49, 95% CI = 0.07, 0.91)., Conclusions: Increased social distancing was not associated with change in incidence of EPLB but was associated with a higher gestational age of extremely preterm births., Gov Id: Generic Database: NCT00063063., (© 2024. The Author(s).)- Published
- 2024
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13. Early and exclusive enteral nutrition in infants born very preterm.
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Razzaghy J, Shukla VV, Gunawan E, Reeves A, Nguyen K, and Salas AA
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- Humans, Infant, Newborn, Male, Female, Intensive Care Units, Neonatal, Length of Stay statistics & numerical data, Gestational Age, Infant Nutritional Physiological Phenomena, Body Composition, Enteral Nutrition methods, Infant, Extremely Premature, Milk, Human
- Abstract
Objective: To characterise the effects of early and exclusive enteral nutrition with either maternal or donor milk in infants born very preterm (28
0/7 -326/7 weeks of gestation)., Design: Parallel-group, unmasked randomised controlled trial., Setting: Regional, tertiary neonatal intensive care unit., Participants: 102 infants born very preterm between 2021 and 2022 (51 in each group)., Intervention: Infants randomised to the intervention group received 60-80 mL/kg/day within the first 36 hours after birth. Infants randomised to the control group received 20-30 mL/kg/day (standard trophic feeding volumes)., Main Outcome Measures: The primary outcome was the number of full enteral feeding days (>150 mL/kg/day) in the first 28 days after birth. Secondary outcomes included growth and body composition at the end of the first two postnatal weeks, and length of hospitalisation., Results: The mean birth weight was 1477 g (SD: 334). Half of the infants were male, and 44% were black. Early and exclusive enteral nutrition increased the number of full enteral feeding days (+2; 0-2 days; p=0.004), the fat-free mass-for-age z-scores at postnatal day 14 (+0.5; 0.1-1.0; p=0.02) and the length-for-age z-scores at the time of hospital discharge (+0.6; 0.2-1.0; p=0.002). Hospitalisation costs differed between groups (mean difference favouring the intervention group: -$28 754; -$647 to -$56 861; p=0.04)., Conclusions: In infants born very preterm, early and exclusive enteral nutrition increases the number of full enteral feeding days. This feeding practice may also improve fat-free mass accretion, increase length and reduce hospitalisation costs., Trial Registration Number: NCT04337710., Competing Interests: Competing interests: AAS has a patent for an instrumented feeding bottle. Additionally, AAS has provided scientific advice to Resbiotic, received consulting fees for participating in advisory board meetings for Reckitt/Mead Johnson Nutrition and received speaking fees for participating in educational activities organised by p-value communications and WebMD., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)- Published
- 2024
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14. Histological Chorioamnionitis Increases the Risk of Bronchopulmonary Dysplasia.
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Jain VG, Parikh NA, Rysavy MA, Shukla VV, Trotta M, Jobe A, Carlo WA, and Ambalavanan N
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- Humans, Pregnancy, Female, Infant, Newborn, Risk Factors, Infant, Premature, Male, Adult, Bronchopulmonary Dysplasia etiology, Chorioamnionitis pathology
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- 2024
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15. Persistent disparities in black infant mortality across gestational ages in the United States.
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Shukla VV, Youngblood EM, Tindal RR, Carlo WA, and Travers CP
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- Humans, Infant, Black People, Gestational Age, United States epidemiology, Infant Mortality, Black or African American
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- 2024
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16. A few breaths at birth; a lifetime of health.
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Carlo WA and Shukla VV
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- Infant, Newborn, Humans, Respiration, Infant, Premature
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Competing Interests: Conflicts of interest The authors declare no conflicts of interest.
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- 2023
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17. Trends in fetal and neonatal outcomes during the COVID-19 pandemic in Alabama.
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Shukla VV, Rahman AKMF, Shen X, Black A, Arora N, Lal CV, Bell EF, Nakhmani A, Zhang C, Ambalavanan N, and Carlo WA
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- Infant, Newborn, Pregnancy, Female, Humans, Pandemics, Alabama epidemiology, Infant Mortality, Stillbirth epidemiology, COVID-19
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Background: The current study evaluated the hypothesis that the COVID-19 pandemic is associated with higher stillbirth but lower neonatal mortality rates., Methods: We compared three epochs: baseline (2016-2019, January-December, weeks 1-52, and 2020, January-February, weeks 1-8), initial pandemic (2020, March-December, weeks 9-52, and 2021, January-June, weeks 1-26), and delta pandemic (2021, July-September, weeks 27-39) periods, using Alabama Department of Public Health database including deliveries with stillbirths ≥20 weeks or live births ≥22 weeks gestation. The primary outcomes were stillbirth and neonatal mortality rates., Results: A total of 325,036 deliveries were included (236,481 from baseline, 74,076 from initial pandemic, and 14,479 from delta pandemic period). The neonatal mortality rate was lower in the pandemic periods (4.4 to 3.5 and 3.6/1000 live births, in the baseline, initial, and delta pandemic periods, respectively, p < 0.01), but the stillbirth rate did not differ (9 to 8.5 and 8.6/1000 births, p = 0.41). On interrupted time-series analyses, there were no significant changes in either stillbirth (p = 0.11 for baseline vs. initial pandemic period, and p = 0.67 for baseline vs. delta pandemic period) or neonatal mortality rates (p = 0.28 and 0.89, respectively)., Conclusions: The COVID-19 pandemic periods were not associated with a significant change in stillbirth and neonatal mortality rates compared to the baseline period., Impact: The COVID-19 pandemic could have resulted in changes in fetal and neonatal outcomes. However, only a few population-based studies have compared the risk of fetal and neonatal mortality in the pandemic period to the baseline period. This population-based study identifies the changes in fetal and neonatal outcomes during the initial and delta COVID-19 pandemic period as compared to the baseline period. The current study shows that stillbirth and neonatal mortality rates were not significantly different in the initial and delta COVID-19 pandemic periods as compared to the baseline period., (© 2023. The Author(s), under exclusive licence to the International Pediatric Research Foundation, Inc.)
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- 2023
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18. ECI Bio-commentary: Vivek V. Shukla.
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Shukla VV
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- 2023
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19. Association of Active Postnatal Care With Infant Survival Among Periviable Infants in the US.
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Silva ER, Shukla VV, Tindal R, Carlo WA, and Travers CP
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- Infant, Newborn, Infant, Humans, Female, Pregnancy, Male, Cohort Studies, Gestational Age, Infant Mortality, Adrenal Cortex Hormones, Intensive Care, Neonatal, Postnatal Care
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Importance: Active postnatal care has been associated with center differences in survival among periviable infants. Regional differences in outcomes among periviable infants in the US may be associated with differences in active postnatal care., Objective: To determine if regions with higher rates of active postnatal care will have higher gestational age-specific survival rates among periviable infants., Design, Setting, and Participants: This cohort study included live births from 22 to 25 weeks' gestation weighing 400 to 999 g in the US Centers for Disease Control and Prevention (CDC) WONDER 2017 to 2020 (expanded) database. Infants with congenital anomalies were excluded. Active postnatal care was defined using the CDC definition of abnormal conditions of newborn as presence of any of the following: neonatal intensive care unit (NICU) admission, surfactant, assisted ventilation, antibiotics, and seizures. Data were analyzed from August to November 2022., Main Outcomes and Measures: Regional gestational age-specific survival rates were compared with rates of active postnatal care in the 10 US Health and Human Services regions using Kendall τ test., Results: We included 41 707 periviable infants, of whom 32 674 (78%) were singletons and 19 467 (46.7%) were female. Among those studied 34 983 (83.9%) had evidence of active care, and 26 009 (62.6%) survived. Regional rates of active postnatal care were positively correlated with regional survival rates at 22 weeks' gestation (rτ[8] = 0.56; r2 = 0.31; P = .03) but the correlation was not significant at 23 weeks' gestation (rτ[8] = 0.47; r2 = 0.22; P = .07). There was no correlation between active care and survival at 24 or 25 weeks' gestation. Regional rates of both NICU admission and assisted ventilation following delivery were positively correlated with regional rates of survival at 22 weeks' gestation (both P < .05). Regional rates of antenatal corticosteroids exposure were also positively correlated with regional rates of survival at 22 weeks' gestation (rτ[8] = 0.60; r2 = 0.36; P = .02)., Conclusions and Relevance: In this cohort study of 41 707 periviable infants, regional differences in rates of active postnatal care, neonatal intensive care unit admission, provision of assisted ventilation and antenatal corticosteroid exposure were moderately correlated with survival at 22 weeks' gestation. Further studies focused on individual-level factors associated with active periviable care are warranted.
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- 2023
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20. Outcome prediction in newborn infants: Past, present, and future.
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Shukla VV, Rysavy MA, Das A, Tyson JE, Bell EF, Ambalavanan N, and Carlo WA
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- Child, Female, Humans, Infant, Infant, Newborn, National Institute of Child Health and Human Development (U.S.), Pregnancy, Prognosis, United States, Aftercare, Patient Discharge
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The perinatal and neonatal periods are the periods of considerable organ development and maturation. Perinatal and neonatal illnesses can result in mortality and morbidities that burden families and the healthcare system. Outcome prediction is essential for informing perinatal and intensive care management, prognosis, and post-discharge interventions. The Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network (NRN) research databases include hospital and neurodevelopment follow-up outcomes of infants with various underlying diseases and conditions receiving intensive care, providing a unique opportunity to assess outcome risk prediction. The NRN has developed outcome risk prediction tools for use in infants with various diseases and conditions that allow data-driven, transparent discussions to inform family-focused communications and clinical management. This review presents the published neonatal outcome risk prediction research from the NRN, their present clinical utility, and possible future directions for advanced individualized risk prediction., Competing Interests: Declaration of Competing Interest Waldemar A. Carlo, MD is on the board of directors of MEDNAX Services, Inc. All other authors have indicated that they have no conflicts of interest relevant to this article to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2022
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21. Prevention of severe brain injury in very preterm neonates: A quality improvement initiative.
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Shukla VV, Klinger A, Yazdi S, Rahman AKMF, Wright S, Barganier A, Ambalavanan N, Carlo WA, and Ramani M
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- Bicarbonates, Cerebral Hemorrhage epidemiology, Humans, Indomethacin therapeutic use, Infant, Infant, Extremely Premature, Infant, Newborn, Prospective Studies, Quality Improvement, Brain Injuries complications, Brain Injuries prevention & control, Leukomalacia, Periventricular epidemiology
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Objective: To determine the impact of neuroprotection interventions bundle on the incidence of severe brain injury or early death (intraventricular hemorrhage grade 3/4 or death by 7 days or ventriculomegaly or cystic periventricular leukomalacia on 1-month head ultrasound, primary composite outcome) in very preterm (27
0/7 to ≤ 296/7 weeks gestational age) infants., Study Design: Prospective quality improvement initiative, from April 2017-September 2019, with neuroprotection interventions bundle including cerebral NIRS, TcCO2 , and HeRO monitoring-based management algorithm, indomethacin prophylaxis, protocolized bicarbonate and inotropes use, noise reduction, and neutral positioning., Result: There was a decrease in the incidence of the primary composite outcome in the intervention period on unadjusted (N = 11/99, pre-intervention to N = 0/127, intervention period, p < 0.001) and adjusted analysis (adjusted for birthweight and Apgar score <5 at 5 min, aOR = 0.042, 95% CI = 0.003-0.670, p = 0.024)., Conclusions: Neuroprotection interventions bundle was associated with significant decrease in severe brain injury or early death in very preterm infants., (© 2022. The Author(s), under exclusive licence to Springer Nature America, Inc.)- Published
- 2022
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22. Neonatal resuscitation from a global perspective.
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Shukla VV, Carlo WA, Niermeyer S, and Guinsburg R
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- Female, Humans, Infant, Infant, Newborn, Parturition, Pregnancy, Quality Improvement, Stillbirth, Infant Mortality, Resuscitation
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The majority of perinatal and neonatal mortality occurs in low-resource settings in low- and middle-income countries. Access and quality of care at delivery are major determinants of the health and survival of newborn infants. Availability of basic neonatal resuscitation care at birth has improved, but basic neonatal resuscitation at birth or high-quality care continues to be inaccessible in some settings, leading to persistently high perinatal and neonatal mortality. Low-resource settings of high-income countries and socially disadvantaged communities also suffer from inadequate access to quality perinatal healthcare. Quality improvement, implementation research, and innovation should focus on improving the quality of perinatal healthcare and perinatal and neonatal outcomes in low-resource settings. The current review presents an update on issues confronting universal availability of optimal resuscitation care at birth and provides an update on ongoing efforts to address them., Competing Interests: Declaration of Competing Interest WAC is on the board of directors of MEDNAX Services, Inc. All other authors have indicated that they have no conflicts of interest relevant to this article to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2022
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23. Hospital and Neurodevelopmental Outcomes in Nano-Preterm Infants Receiving Invasive vs Noninvasive Ventilation at Birth.
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Shukla VV, Souder JP, Imbrock G, Hu M, Rahman AKMF, Travers CP, Ambalavanan N, Carlo WA, and Lal CV
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- Adult, Cohort Studies, Female, Hospitals, Humans, Infant, Infant, Newborn, Infant, Premature, Male, Young Adult, Bronchopulmonary Dysplasia epidemiology, Bronchopulmonary Dysplasia therapy, Noninvasive Ventilation
- Abstract
Importance: Infants with gestational age between 22 0/7 and 23 6/7 weeks (referred to as nano-preterm infants) are at very high risk of adverse outcomes. Noninvasive respiratory support at birth improves outcomes in infants born at 24 0/7 to 27 6/7 weeks' gestational age. Evidence is limited on whether similar benefits of non-invasive respiratory support at birth extend to nano-preterm infants., Objective: To evaluate the hypothesis that intubation at 10 minutes or earlier after birth is associated with a higher incidence of bronchopulmonary dysplasia (BPD) or death by 36 weeks' postmenstrual age (PMA) in nano-preterm infants., Design, Setting, and Participants: This observational cohort study included all nano-preterm infants at a level IV neonatal intensive care unit who were delivered from January 1, 2014, to June 30, 2021. Infants receiving palliative or comfort care at birth were excluded., Exposures: Infants were grouped based on first intubation attempt timing after birth (>10 minutes after birth and ≤10 minutes as noninvasive and invasive respiratory support at birth groups, respectively)., Main Outcomes and Measures: The primary outcome was the composite outcome of BPD (physiological definition) or death by 36 weeks' PMA., Results: All 230 consecutively born, eligible nano-preterm infants were included, of whom 88 (median [IQR] gestational age, 23.6 [23.4-23.7] weeks; 45 [51.1%] female; 54 [62.1%] Black) were in the noninvasive respiratory support at birth group and 142 (median [IQR] gestational age, 23.0 [22.4-23.3] weeks; 71 [50.0%] female; 94 [66.2%] Black) were in the invasive respiratory support at birth group. The incidence of BPD or death by 36 weeks' PMA did not differ between the noninvasive and invasive respiratory support groups (83 of 88 [94.3%] in the noninvasive group vs 129 of 142 [90.9%] in the invasive group; adjusted odds ratio, 2.09; 95% CI, 0.60-7.25; P = .24). Severe intraventricular hemorrhage or death by 36 weeks' PMA was lower in the invasive respiratory support at birth group (adjusted odds ratio, 2.20; 95% CI, 1.07-4.51; P = .03)., Conclusions and Relevance: This cohort study's findings suggest that noninvasive respiratory support in the first 10 minutes after birth is feasible but is not associated with a decrease in the risk of BPD or death compared with intubation and early surfactant delivery in nano-preterm infants.
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- 2022
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24. Efficacy of Skin-to-Skin Care versus Swaddling for Pain Control Associated with Vitamin K Administration in Full-Term Neonates: A Randomized Controlled Trial.
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Patel DV, Soni SN, Shukla VV, Phatak AG, Shinde MK, Nimbalkar AS, and Nimbalkar SM
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- Female, Humans, Infant, Newborn, Injections, Intramuscular, Pain drug therapy, Pain etiology, Pain prevention & control, Skin Care, Pain Management, Vitamin K
- Abstract
Objective: The objective of the study was to assess the efficacy of immediate skin-to-skin care (SSC) versus swaddling in pain response to intramuscular injection of vitamin K at 30 min of birth in neonates., Methods: Healthy full-term newborns were enrolled immediately after normal vaginal delivery and randomized in two groups, SSC and swaddling. Neonatal Infant Pain Scale (NIPS) was measured before, immediately after and at 2 min after the injection., Results: Total 100 newborns were enrolled in the study (50 in each group). The mean (SD) birth weight of newborns in the SSC and swaddling group was 2668 (256) and 2730 (348) g, respectively. NIPS was comparable between the SSC and swaddling at before [1.78 (0.58) vs. 1.96 (0.83), p = 0.21], and immediately after the injection [4.82 (0.72) vs. 5.08 (0.75), p = 0.08]. NIPS at 2 min after the injection was significantly low in the SSC group compared to the swaddling group [1.38 (0.70) vs. 2.88 (1.00), p < 0.001]. At 2 min after injection, the NIPS score was significantly lower than baseline in the SSC group (p = 0.002), while it was significantly higher in the swaddling group (p < 0.001). A significantly higher proportion of newborns had a NIPS score of more than three at 2 min after injection in the swaddling group as compared to the SSC group (22% vs. 2%, p < 0.001)., Conclusion: Immediate SSC was more efficacious as compared to swaddling as a pain control intervention while giving vitamin K injection., Clinical Trial Registration: The trial is registered with the Clinical Trial Registry of India with Registration number: CTRI/2020/01/022984., (© The Author(s) [2022]. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2022
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25. Trends in Maternal Outcomes During the COVID-19 Pandemic in Alabama From 2016 to 2021.
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Shukla VV, Rahman AF, Shen X, Black A, Nakhmani A, Ambalavanan N, and Carlo WA
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- Alabama epidemiology, Humans, Pandemics, SARS-CoV-2, COVID-19 epidemiology
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- 2022
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26. Risk Prediction for Stillbirth and Neonatal Mortality in Low-resource Settings.
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Shukla VV and Carlo WA
- Abstract
High stillbirth and neonatal mortality are major public health problems, particularly in low-resource settings in low- and middle-income countries (LMIC). Despite sustained efforts by national and international organizations over the last several decades, quality intrapartum and neonatal care is not universally available, especially in these low-resource settings. A few studies identify risk factors for adverse perinatal outcomes in low-resource settings in LMICs. This review highlights the evidence of risk prediction for stillbirth and neonatal death. Evidence using advanced machine-learning statistical models built on data from low-resource settings in LMICs suggests that the predictive accuracy for intrapartum stillbirth and neonatal mortality using prenatal and pre-delivery data is low. Models with delivery and post-delivery data have good predictive accuracy of the risk for neonatal mortality. Birth weight is the most important predictor of neonatal mortality. Further validation and testing of the models in other low-resource settings and subsequent development and testing of possible interventions could advance the field., Competing Interests: Conflict of interest: None
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- 2022
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27. Predictive Ability of 10-Minute Apgar Scores for Mortality and Neurodevelopmental Disability.
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Shukla VV, Bann CM, Ramani M, Ambalavanan N, Peralta-Carcelen M, Hintz SR, Higgins RD, Natarajan G, Laptook AR, Shankaran S, and Carlo WA
- Subjects
- Apgar Score, Child, Gestational Age, Humans, Infant, Infant, Newborn, Resuscitation, United States, Hypothermia, Induced, Hypoxia-Ischemia, Brain complications, Hypoxia-Ischemia, Brain diagnosis, Hypoxia-Ischemia, Brain therapy
- Abstract
Objective: To test the hypothesis that an Apgar score at 10 minutes is independently predictive for death or moderate or severe disability., Methods: A secondary analysis of the Optimizing Cooling Trial (NCT01192776) including 347 infants with ≥36 weeks' gestational age at birth and hypoxic-ischemic encephalopathy and 18- to 22-month outcomes from 18 US centers in the National Institute of Child Health and Human Development Neonatal Research Network. The primary outcome was the composite of death or moderate/severe disability at 18 to 22 months of age. Generalized estimating equation models were used to examine the relationship between Apgar scores and outcomes, controlling for center, hypothermia treatment, and severity of hypoxic-ischemic encephalopathy (HIE). Classification and regression tree analyses were conducted to identify combinations of variables available during resuscitation that were most predictive for the composite outcome and death., Results: The study revealed that 50% (13 of 26) of infants with a 10-minute Apgar score of 0 survived; 46% (6 of 13) had no disability, 16% (2 of 13) had mild disability, and 38% (5 of 13) had moderate or severe disability. The 10-minute Apgar score of 0 was independently associated with death or moderate or severe disability (adjusted relative risk = 1.72, 95% confidence interval 1.11-2.68, P value = .016), but the area under the curve analysis (AUC) was low (AUC = 0.56). The predictive accuracy improved when the 10-minute Apgar score was combined with other risk variables available during resuscitation by using a classification and regression tree analysis (AUC = 0.66)., Conclusions: A 10-minute Apgar score of 0 alone does not predict the risk of death or moderate or severe disability well. The current study provides evidence in support of the 2020 American Heart Association/International Liaison Committee on Resuscitation recommendation for continuing resuscitative efforts for infants who need cardiopulmonary resuscitation at 10 minutes after birth., Competing Interests: CONFLICT OF INTEREST DISCLOSURES: Waldemar A. Carlo is on the board of directors of MEDNAX Services, Inc. All other authors have indicated that they have no conflicts of interest relevant to this article to disclose., (Copyright © 2022 by the American Academy of Pediatrics.)
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- 2022
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28. A Quality Improvement Bundle to Improve Outcomes in Extremely Preterm Infants in the First Week.
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Travers CP, Gentle S, Freeman AE, Nichols K, Shukla VV, Purvis D, Dolma K, Winter L, Ambalavanan N, Carlo WA, and Lal CV
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- Academic Medical Centers trends, Female, Humans, Infant, Infant, Newborn, Intracranial Hemorrhages diagnosis, Male, Treatment Outcome, Academic Medical Centers standards, Infant, Extremely Premature growth & development, Intracranial Hemorrhages mortality, Intracranial Hemorrhages therapy, Perinatal Mortality trends, Quality Improvement standards
- Abstract
Objectives: Our objective with this quality improvement initiative was to reduce rates of severe intracranial hemorrhage (ICH) or death in the first week after birth among extremely preterm infants., Methods: The quality improvement initiative was conducted from April 2014 to September 2020 at the University of Alabama at Birmingham's NICU. All actively treated inborn extremely preterm infants without congenital anomalies from 22 + 0/7 to 27 + 6/7 weeks' gestation with a birth weight ≥400 g were included. The primary outcome was severe ICH or death in the first 7 days after birth. Balancing measures included rates of acute kidney injury and spontaneous intestinal perforation. Outcome and process measure data were analyzed by using p-charts., Results: We studied 820 infants with a mean gestational age of 25 + 3/7 weeks and median birth weight of 744 g. The rate of severe ICH or death in the first week after birth decreased from the baseline rate of 27.4% to 15.0%. The rate of severe ICH decreased from a baseline rate of 16.4% to 10.0%. Special cause variation in the rate of severe ICH or death in the first week after birth was observed corresponding with improvement in carbon dioxide and pH targeting, compliance with delayed cord clamping, and expanded use of indomethacin prophylaxis., Conclusions: Implementation of a bundle of evidence-based potentially better practices by using specific electronic order sets was associated with a lower rate of severe ICH or death in the first week among extremely preterm infants., Competing Interests: FINANCIAL DISCLOSURE: Golden Week Program is trademarked with the US Patent and Trademark Office (serial number 87856747). The authors have indicated they have no financial relationships relevant to this article to disclose., (Copyright © 2022 by the American Academy of Pediatrics.)
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- 2022
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29. Neonatal Resuscitation Research Priorities in Low- and Middle-Income Countries.
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Shukla VV and Nimbalkar SM
- Abstract
Several critical physiological changes occur during birth. Optimal and timely resuscitation is essential to avoid morbidity and mortality. The International Liaison Committee on Resuscitation (ILCOR) is a multinational committee that publishes evidence-based consensus and treatment recommendations for resuscitation in various scenarios including that for neonatal resuscitation. The majority of perinatal deaths occur in low- and middle-income countries (LMICs); however, there is limited research output from LMICs to generate evidence-based practice recommendations specific for LMICs. The current review identifies key areas of neonatal resuscitation-related research needed from LMICs to inform evidence-based resuscitation of neonates in LMICs., Competing Interests: All authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2021 Vivek V. Shukla and Somashekhar M. Nimbalkar.)
- Published
- 2021
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30. Recent Advances in Bronchopulmonary Dysplasia.
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Shukla VV and Ambalavanan N
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- Humans, Infant, Infant, Extremely Premature, Infant, Newborn, Oxygen, Respiration, Artificial, Bronchopulmonary Dysplasia etiology, Bronchopulmonary Dysplasia therapy
- Abstract
Bronchopulmonary dysplasia (BPD) is a form of chronic lung disease that occurs in preterm infants, usually those receiving substantial respiratory support with either mechanical ventilation or supplementation with oxygen. The pathogenesis of BPD is multifactorial, and the clinical phenotype is variable. BPD is associated with substantial mortality and short- and long-term morbidity. The incidence of BPD has remained stable or increased, as advances in neonatal care have led to improved survival of more extremely preterm infants. Extensive basic science, translational, and clinical research focusing on BPD has improved the current understanding of the factors that contribute to BPD pathogenesis. However, despite a better understanding of its pathophysiology, BPD continues to be challenging to prevent and manage adequately. The current review aims to provide a clinically useful synopsis of evidence on the prevention and management of BPD in preterm infants.
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- 2021
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31. Skin-to-Skin Care by Mother vs. Father for Preterm Neonatal Pain: A Randomized Control Trial (ENVIRON Trial).
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Shukla VV, Chaudhari AJ, Nimbalkar SM, Phatak AG, Patel DV, and Nimbalkar AS
- Abstract
Objective: To compare skin-to-skin care (SSC) given by mother and father for preterm neonatal pain control by premature infant pain profile (PIPP) score., Methods: 64 stable preterm (28-36 weeks gestational age) neonates born at a level-3 neonatal intensive care unit were included in the trial. Random allocation with the help of a computer-generated sequence was done. In group A, SSC was given by the mother 15 minutes before the first heel-stick, and subsequently, SSC was given by the father before the second heel-stick. In group B, the sequence of SSC provider was reversed. Blinded PIPP score assessment at 0, 1, and 5 minutes of heel-stick were done by two independent assessors using video recording., Results: The mean (SD) birth weight was 1665.18 (339.35) grams, and mean (SD) gestational age was 34.28 (2.24) weeks. The PIPP score at 0, 1, and 5 minutes had no statistical or clinically significant differences between both groups (PIPP score mean (SD) at 0 minute = 3.20 (1.11) vs. 3.01 (1.29), p value = 0.38; 1 minute = 8.59 (4.27) vs. 8.26 (4.08), p value = 0.66; 5 minutes = 3.79 (1.40) vs. 3.93 (1.99), p value = 0.65 in SSC by mother and father group, respectively). Furthermore, there was no statistical difference between the groups for any components of the PIPP score (all p values > 0.05). The PIPP score at 5 minutes almost attained the 0-minute level in both the groups., Conclusion: Father is as effective as the mother for providing skin-to-skin care for preterm neonatal pain control. This trial is registered with CTRI/2018/01/016783., Competing Interests: All authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2021 Vivek Vishwanath Shukla et al.)
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- 2021
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32. Predictive Modeling for Perinatal Mortality in Resource-Limited Settings.
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Shukla VV, Eggleston B, Ambalavanan N, McClure EM, Mwenechanya M, Chomba E, Bose C, Bauserman M, Tshefu A, Goudar SS, Derman RJ, Garcés A, Krebs NF, Saleem S, Goldenberg RL, Patel A, Hibberd PL, Esamai F, Bucher S, Liechty EA, Koso-Thomas M, and Carlo WA
- Subjects
- Adult, Birth Weight, Cohort Studies, Congo epidemiology, Female, Guatemala epidemiology, Humans, India epidemiology, Infant, Infant Mortality, Infant, Newborn, Kenya epidemiology, Male, Pakistan epidemiology, Predictive Value of Tests, Pregnancy, Prospective Studies, Risk Factors, Zambia epidemiology, Health Resources trends, Perinatal Death etiology, Perinatal Mortality trends, Stillbirth epidemiology
- Abstract
Importance: The overwhelming majority of fetal and neonatal deaths occur in low- and middle-income countries. Fetal and neonatal risk assessment tools may be useful to predict the risk of death., Objective: To develop risk prediction models for intrapartum stillbirth and neonatal death., Design, Setting, and Participants: This cohort study used data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research population-based vital registry, including clinical sites in South Asia (India and Pakistan), Africa (Democratic Republic of Congo, Zambia, and Kenya), and Latin America (Guatemala). A total of 502 648 pregnancies were prospectively enrolled in the registry., Exposures: Risk factors were added sequentially into the data set in 4 scenarios: (1) prenatal, (2) predelivery, (3) delivery and day 1, and (4) postdelivery through day 2., Main Outcomes and Measures: Data sets were randomly divided into 10 groups of 3 analysis data sets including training (60%), test (20%), and validation (20%). Conventional and advanced machine learning modeling techniques were applied to assess predictive abilities using area under the curve (AUC) for intrapartum stillbirth and neonatal mortality., Results: All prenatal and predelivery models had predictive accuracy for both intrapartum stillbirth and neonatal mortality with AUC values 0.71 or less. Five of 6 models for neonatal mortality based on delivery/day 1 and postdelivery/day 2 had increased predictive accuracy with AUC values greater than 0.80. Birth weight was the most important predictor for neonatal death in both postdelivery scenarios with independent predictive ability with AUC values of 0.78 and 0.76, respectively. The addition of 4 other top predictors increased AUC to 0.83 and 0.87 for the postdelivery scenarios, respectively., Conclusions and Relevance: Models based on prenatal or predelivery data had predictive accuracy for intrapartum stillbirths and neonatal mortality of AUC values 0.71 or less. Models that incorporated delivery data had good predictive accuracy for risk of neonatal mortality. Birth weight was the most important predictor for neonatal mortality.
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- 2020
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33. Blinded randomized crossover trial: Skin-to-skin care vs. sucrose for preterm neonatal pain.
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Nimbalkar S, Shukla VV, Chauhan V, Phatak A, Patel D, Chapla A, and Nimbalkar A
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- Cross-Over Studies, Humans, Infant, Newborn, Infant, Premature, Skin Care, Pain, Sucrose
- Abstract
Objective: To compare skin-to-skin care (SSC) and oral sucrose for preterm neonatal pain control., Methods: Preterm neonates (28-36 weeks gestation) requiring heel-stick were eligible. In group-A, SSC was given 15-min before first heel-stick, and sucrose was given 2-min before second heel-stick. In group-B, the sequence was reversed. Blinded premature infant pain profile (PIPP) score assessment was done at 0, 1, and 5-min of heel-stick by two assessors., Results: A hundred neonates were enrolled. The inter-rater agreement for the PIPP score was good. The behavior state component was significantly lower in the sucrose group at all assessment points. The mean (SD) difference between 1-min and 0 min was similar [SSC 3.58(3.16) vs. sucrose 4.09(3.82), p = 0.24] between groups. The PIPP score attained baseline values at 5-min in both groups., Conclusion: Albeit sucrose indicated instantaneous action, SSC and sucrose have comparable clinical efficacy for preterm neonatal pain control. Multisensory stimulation with SSC may result in a higher behavioral state component of the PIPP score.
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- 2020
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34. Review of the evidence for interventions to reduce perinatal mortality in low- and middle-income countries.
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Shukla VV and Carlo WA
- Abstract
Low- and middle-income countries contribute to the overwhelming majority of the global perinatal and neonatal mortality. There is a growing amount of literature focused on interventions aimed at reducing the healthcare gaps and thereby reducing perinatal and neonatal mortality in low- and middle-income countries. The current review synthesizes available evidence for interventions that have shown to improve perinatal and neonatal outcomes. Reduction in important gaps in the availability and utilization of perinatal care practices is needed to end preventable deaths of newborns., (© 2020 Publishing services provided by Elsevier B.V. on behalf of King Faisal Specialist Hospital & Research Centre (General Organization), Saudi Arabia.)
- Published
- 2020
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35. Early Outcomes of Neonatal Cardiac Surgery in India.
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Shukla VV, Bobhate P, Mohanty S, Rao S, Joshi P, and Joshi V
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- Female, Humans, India, Infant, Newborn, Male, Operative Time, Postoperative Complications, Retrospective Studies, Risk Factors, Treatment Outcome, Cardiac Surgical Procedures adverse effects, Cardiac Surgical Procedures methods, Cardiac Surgical Procedures mortality, Heart Defects, Congenital epidemiology, Heart Defects, Congenital mortality, Heart Defects, Congenital surgery
- Abstract
Objective: To assess outcomes and factors influencing outcomes in neonates requiring cardiac surgery in India., Methods: This study reports on review of hospital data from a tertiary care cardiac surgical institute from January-2009 to December-2015., Results: A total of 200 neonates were included; of them, 5% of the cases were antenatally diagnosed and most of them had unmonitored transport (111, 55.5%). The overall mortality rate was 13.5%, (n=27) and 178 (89%) underwent complete defect repair. There was a significant association of mortality with shock, the number of inotropes, intra-operative procedure, residual lesion, aortic cross-clamp and deep hypothermic circulatory arrest time (all P<0.05). Logistic regression analysis showed ventilation duration, cardiac-bypass time, shock, and residual cardiac lesion as independent predictors of mortality., Conclusions: Cardiac defects were found to have late detection and most transports were unmonitored. Complete surgical repair and shorter cardiac bypass time can potentially improve neonatal cardiac surgical outcomes.
- Published
- 2020
36. Vaccinations in Primary Care.
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Shukla VV and Shah RC
- Subjects
- Child, Drug Costs, Drug Storage, Humans, Immunity, Active, Immunization Schedule, Primary Health Care, Vaccination adverse effects, Vaccination economics, Vaccines adverse effects, Vaccines economics
- Abstract
Vaccination is amongst the best strategies to improve child survival and reduce morbidity. Vaccines represent the most cost effective and simple intervention to protect against distressing epidemics. There are mortality and morbidity related benefits derived from preventing infectious diseases through vaccination; these include financial benefits by avoiding hospitalization, preventing long-term disability and increased productivity. Ever since the invention of the first vaccine against smallpox by Edward Jenner in 1796, vaccination has become indispensable healthcare intervention and has saved millions of lives. Due to significant scientific progress, many vaccines are available and numerous are anticipated; however, vaccine preventable infectious diseases are still prevalent. Due to rapid pace of developments in the field of vaccination, providers must continue to update their knowledge. The present review is aimed at helping general practitioners understand routine vaccinations, their considerations, issues and side effects.
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- 2018
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37. Pain Control Interventions in Preterm Neonates: Few concerns: Author's Reply.
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Shukla VV
- Subjects
- Humans, Infant, Newborn, Pain, Infant, Premature, Pain Management
- Published
- 2018
38. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial.
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Shukla VV, Bansal S, Nimbalkar A, Chapla A, Phatak A, Patel D, and Nimbalkar S
- Subjects
- Female, Follow-Up Studies, Humans, Infant, Newborn, Kangaroo-Mother Care Method, Male, Milk, Human, Music Therapy, Pain Measurement, Pain, Procedural diagnosis, Pain, Procedural etiology, Single-Blind Method, Treatment Outcome, Blood Specimen Collection adverse effects, Infant, Premature, Pain Management methods, Pain, Procedural therapy
- Abstract
Objective: To compare individual efficacy and additive effects of pain control interventions in preterm neonates., Design: Randomized controlled trial., Setting: Level-3 University affiliated neonatal intensive care unit., Participants: 200 neonates (26-36 wk gestational age) requiring heel-prick for bedside glucose assessment. Exclusion criteria were neurologic impairment and critical illness precluding study interventions., Intervention: Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control (no additional intervention) groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention., Main Outcome Measures: Assessment of pain using Premature Infant Pain Profile (PIPP) score on recorded videos., Results: The mean (SD) birth weight and gestational age of the neonates was 1.9 (0.3) kg and 34 (2.3) wk, respectively. Analysis of variance showed significant difference in total PIPP score across groups (P<0.001). Post-hoc comparisons using Sheffe's test revealed that the mean (SD) total PIPP score was significantly lower in Kangaroo mother care group [7.7 (3.9) vs. 11.5 (3.4), 95% CI(-5.9, -1.7), P<0.001] as well as Kangaroo mother care with Music therapy group [8.5 (3.2) vs. 11.5 (3.4), 95%CI (-5.1, -0.9), P=0.001] as compared to Control group. PIPP score was not significantly different between Control group and Music therapy group., Conclusions: Kangaroo mother care with and without Music therapy (with expressed breast milk) significantly reduces pain on heel-prick as compared to expressed breast milk alone. Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates.
- Published
- 2018
39. Direct Cost of Critical Illness Associated Healthcare Expenditures among Children Admitted in Pediatric Intensive Care Unit in Rural India.
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Shukla VV, Nimbalkar SM, Ganjiwale JD, and John D
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- Child, Humans, India, Intensive Care Units, Pediatric, Male, Prospective Studies, Rural Population, Critical Illness, Health Expenditures
- Abstract
Objective: To assess the direct costs involved in treatment of children receiving intensive care in a university-affiliated teaching hospital and its associated implications on the children's families, in rural India., Methods: It was a prospective observational study for cost-analysis using questionnaire based interviews and billing records data collection for admissions to the PICU over 27 consecutive months (January 2010 through March 2012)., Results: A total of 784 children were admitted to the unit during the assessment period. Full details of 633 children were included for analysis. The average length of stay was 6.16 d, average hospital expenditure was US$185.67, average hospital expenses per day was US$44.00, average pharmacy expenditure was US$109.67 and average pharmacy expenditure per day was US$20.62 per patient. Children who were ventilated had approximately 61 % more expense per day as compared to non-ventilated ones. Boys and those with health insurance reported higher length of stay. Linear hierarchical regression with backward LR model showed that mechanical ventilation, multiple organ dysfunction, length of stay and insurance cover were the variables significantly affecting the final expenses., Conclusions: There is a high direct expenditure incurred by families of children receiving intensive care when seen in perspective of high rates of extreme poverty in rural India. These high expenditures make critical care unaffordable to majority of the population lacking insurance cover in resource limited regions with limited universal health coverage, which ultimately leads to suboptimal care and high childhood mortality. It is highly imperative for the governments and global health organizations to be sensitive towards this issue and to plan strategies for the same across different nations.
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- 2016
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40. Human Milk Feeding as a Protective Factor for Retinopathy of Prematurity: A Meta-analysis.
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Zhou J, Shukla VV, John D, and Chen C
- Subjects
- Humans, Incidence, Infant, Newborn, Infant, Premature, Odds Ratio, Protective Factors, Retinopathy of Prematurity epidemiology, Retinopathy of Prematurity etiology, Severity of Illness Index, Infant Formula, Infant Nutritional Physiological Phenomena, Milk, Human, Retinopathy of Prematurity prevention & control
- Abstract
Context: Studies have suggested that human milk feeding decreases the incidence of retinopathy of prematurity (ROP); however, conflicting results have been reported., Objective: The aim of this meta-analysis was to pool currently available data on incidence of ROP in infants fed human milk versus formula., Data Sources: Medline, PubMed, and EBSCO were searched for articles published through February 2015., Study Selection: Longitudinal studies comparing the incidence of ROP in infants who were fed human milk and formula were selected. Studies involving donor milk were not included., Data Extraction: Two independent reviewers conducted the searches and extracted data. Meta-analysis used odds ratios (ORs), and subgroup analyses were performed., Results: Five studies with 2208 preterm infants were included. Searches including various proportions of human milk versus formula, any-stage ROP, and severe ROP were defined to pool data for analyses. For any-stage ROP, the ORs (95% confidence intervals [CIs]) were as follows: exclusive human milk versus any formula, 0.29 (0.12 to 0.72); mainly human milk versus mainly formula, 0.51 (0.26 to 1.03); any human milk versus exclusive formula, 0.54 (0.15 to 1.96); and exclusive human milk versus exclusive formula, 0.25 (0.13 to 0.49). For severe ROP, they were 0.11 (0.04 to 0.30), 0.16 (0.06 to 0.43), 0.42 (0.08 to 2.18), and 0.10 (0.04 to 0.29), respectively., Limitations: Prospective randomized studies being impossible because of ethical issues, we chose observational studies for analysis. A few studies involving subgroup analyses presented high heterogeneity., Conclusions: Based on current limited evidence, in very preterm newborns, human milk feeding potentially plays a protective role in preventing any-stage ROP and severe ROP., (Copyright © 2015 by the American Academy of Pediatrics.)
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- 2015
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41. Critical Analysis of PIM2 Score Applicability in a Tertiary Care PICU in Western India.
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Shukla VV, Nimbalkar SM, Phatak AG, and Ganjiwale JD
- Abstract
Objective. Children have limited physiological reserve that deteriorates rapidly. Present study profiled patients admitted to PICU and determined PIM2 score applicability in Indian setting. Patients and Methods. Prospective observational study. Results. In 742 consecutive admissions, male : female ratio was 1.5 : 1, 35.6% patients were ventilated, observed mortality was 7%, and 26.4% were <1 year. The profile included septicemia and septic shock (29.6%), anemia (27.1%), pneumonia (19.6%), and meningitis and encephalitis (17.2%). For the first year, sensitivity of PIM2 was 65.8% and specificity was 71% for cutoff value at 1.9 by ROC curve analysis. The area under the curve was 0.724 (95% CI: 0.69, 0.76). This cutoff was validated for second year data yielding similar sensitivity (70.6%) and specificity (65%). Logistic regression analysis (LRA) over entire data revealed various variables independently associated with mortality along with PIM2 score. Another logistic model with same input variables except PIM2 yielded the same significant variables with Nagelkerke R square of 0.388 and correct classification of 78.5 revealing contribution of PIM2 in predicting mortality is meager. Conclusion. Infectious diseases were the commonest cause of PICU admission and mortality. PIM2 scoring did not explain the outcome adequately, suggesting need for recalibration. Following PALS/GEM guidelines was associated with better outcome.
- Published
- 2014
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42. Newborn care practices and health seeking behavior in urban slums and villages of Anand, Gujarat.
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Nimbalkar AS, Shukla VV, Phatak AG, and Nimbalkar SM
- Subjects
- Breast Feeding statistics & numerical data, Health Knowledge, Attitudes, Practice, Home Childbirth statistics & numerical data, Humans, India, Infant, Newborn, Logistic Models, Rural Population, Urban Population, Health Behavior, Infant Care methods, Infant Care statistics & numerical data, Patient Acceptance of Health Care statistics & numerical data, Poverty Areas
- Abstract
Health status of neonates in urban slums has not been studied in smaller towns. A questionnaire was administered to 154 families of 10 urban slums of Anand (population - 197351) and 160 families from 6 villages of Anand district. The socioeconomic and education status of the slum dwellers versus rural participants were significantly lower (P<0.001). Antenatal care (79.9 vs 94.4%, P<0.001), hospital delivery (82.5 vs 93.8%, P=0.002), neonatal follow-up (27.9 vs 78.8%, P<0.001), health seeking (56.5 vs 91.3%, P<0.001), essential newborn care and exclusive breastfeeding (6.5 vs 85.6%, P<0.001) were also lower in urban slums, as compared to villages, Care seeking was low in urban slums, Hindus and illiterate mothers. Health care and socioeconomic status of neonates in slums of smaller cities is poorer than in surrounding villages.
- Published
- 2013
- Full Text
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