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1. Association of Early Postnatal Transfer and Birth Outside a Tertiary Hospital With Mortality and Severe Brain Injury in Extremely Preterm Infants: Observational Cohort Study With Propensity Score Matching

Author

Helenius, K, Longford, N, Lehtonen, L, Modi, N, Gale, C, Babirecki, M, Kamalanathan, A, Wickham, T, Aucharaz, K, Gupta, A, Paul, N, Wong, LM, Mittal, A, Broggio, P, Surana, P, Singh, A, Seal, S, Hassan, A, Schwarz, K, Thomas, M, Foo, A, Anderson, J, Whincup, G, Brearey, S, Chang, J, Gad, K, Hasib, A, Garbash, M, Allwood, A, Adiotomre, P, Brooke, N, Deketelaere, A, Khader, KA, Shephard, R, Rekha, S, Abuzgia, B, Jain, M, Pirie, S, Zengeya, S, Watts, T, Balal, S, Seagrave, C, Bate, T, Dixon, H, Aladangady, N, Gaili, H, James, M, Lal, M, Ambadkar, P, Pandey, P, Hickey, A, Rhodes, S, Pai, V, Lama, M, Miall, L, Cusack, J, Kairamkonda, V, Grosdenier, M, Kollipara, L, Kefas, J, Yoxall, B, Birch, J, Whitehead, G, Krishnamurthy, R, Sashikumar, P, Misra, I, Pillay, T, Ali, I, Thiagarajan, P, Dyke, M, Selter, M, Kamath, P, Alsford, L, Spencer, V, Gupta, S, Nicholl, R, Wardle, S, Chakrabarti, S, Adams, E, McDevitt, K, Reddy, A, Gibson, D, Khashu, M, Reddy, C, Pearson, F, Amess, P, Deshpande, S, Sleight, E, Groves, C, Godambe, S, Bosman, D, Rewitzky, G, Banjoko, O, Kumar, N, Muogbo, D, Lopez, W, D'Amore, A, Mattara, S, Zipitis, C, De Halpert, P, Settle, P, Munyard, P, McIntyre, J, Bartle, D, Pain, K, Fedee, J, Maddock, N, Gupta, R, Moore, A, Godden, C, Jones, S, Fenton, A, Mahadevan, S, Brown, N, Mack, K, Bolton, R, Khan, A, Mannix, P, Huddy, C, Yasin, S, Butterworth, S, Nedungadi, S, Cairns, P, Reynolds, P, Brennan, N, Heal, C, Salgia, S, Abu-Harb, M, Knight, C, Clark, S, Theron, M, Murthy, V, Paul, S, Kisat, H, Kendall, G, Blake, K, Obi, O, Kumar, H, Rawlingson, C, Webb, D, Bird, S, Narayanan, S, Eyre, E, Evans, I, Sanghavi, R, Sullivan, C, Garr, R, Leith, W, Vasu, V, Harry, L, Vamvakiti, K, Vemuri, G, Eaton, M, and Samy, M

Subjects
Male, Pediatrics, LEVEL, Neonatal Data Analysis Unit and the United Kingdom Neonatal Collaborative, Infant, Premature, Diseases, Tertiary Care Centers, HEMORRHAGE, 0302 clinical medicine, 030202 anesthesiology, Pregnancy, Infant Mortality, 030212 general & internal medicine, WEIGHT INFANTS, Finland, 030219 obstetrics & reproductive medicine, Confounding, Pregnancy Outcome, Gestational age, Obstetrics and Gynecology, General Medicine, 3. Good health, Infant, Extremely Premature, Number needed to treat, Female, Life Sciences & Biomedicine, REGIONALIZATION, Cohort study, Patient Transfer, medicine.medical_specialty, IN-UTERO, Gestational Age, NEONATAL TRANSPORT, 1117 Public Health and Health Services, Odds, 03 medical and health sciences, NEURODEVELOPMENTAL OUTCOMES, MORBIDITY, DELIVERY, Medicine, General & Internal, 030225 pediatrics, General & Internal Medicine, medicine, Humans, Propensity Score, Survival analysis, Science & Technology, business.industry, Delivery Rooms, Extremely preterm, Infant, Newborn, Infant, 1103 Clinical Sciences, Odds ratio, CARE, medicine.disease, Survival Analysis, Confidence interval, Brain Injuries, Propensity score matching, business
Abstract

Objective To determine if postnatal transfer or birth in a non-tertiary hospital is associated with adverse outcomes. Design Observational cohort study with propensity score matching. Setting National health service neonatal care in England; population data held in the National Neonatal Research Database. Participants Extremely preterm infants born at less than 28 gestational weeks between 2008 and 2015 (n=17 577) grouped based on birth hospital and transfer within 48 hours of birth: upward transfer (non-tertiary to tertiary hospital, n=2158), non-tertiary care (born in non-tertiary hospital; not transferred, n=2668), and controls (born in tertiary hospital; not transferred, n=10 866). Infants were matched on propensity scores and predefined background variables to form subgroups with near identical distributions of confounders. Infants transferred between tertiary hospitals (horizontal transfer) were separately matched to controls in a 1:5 ratio. Main outcome measures Death, severe brain injury, and survival without severe brain injury. Results 2181 infants, 727 from each group (upward transfer, non-tertiary care, and control) were well matched. Compared with controls, infants in the upward transfer group had no significant difference in the odds of death before discharge (odds ratio 1.22, 95% confidence interval 0.92 to 1.61) but significantly higher odds of severe brain injury (2.32, 1.78 to 3.06; number needed to treat (NNT) 8) and significantly lower odds of survival without severe brain injury (0.60, 0.47 to 0.76; NNT 9). Compared with controls, infants in the non-tertiary care group had significantly higher odds of death (1.34, 1.02 to 1.77; NNT 20) but no significant difference in the odds of severe brain injury (0.95, 0.70 to 1.30) or survival without severe brain injury (0.82, 0.64 to 1.05). Compared with infants in the upward transfer group, infants in the non-tertiary care group had no significant difference in death before discharge (1.10, 0.84 to 1.44) but significantly lower odds of severe brain injury (0.41, 0.31 to 0.53; NNT 8) and significantly higher odds of survival without severe brain injury (1.37, 1.09 to 1.73; NNT 14). No significant differences were found in outcomes between the horizontal transfer group (n=305) and controls (n=1525). Conclusions In extremely preterm infants, birth in a non-tertiary hospital and transfer within 48 hours are associated with poor outcomes when compared with birth in a tertiary setting. We recommend perinatal services promote pathways that facilitate delivery of extremely preterm infants in tertiary hospitals in preference to postnatal transfer.

Published
2020

2. Core outcome set for studies investigating management of selective fetal growth restriction in twins

Author

Townsend, R., Duffy, J. M. N., Sileo, F., Perry, H., Ganzevoort, W., Reed, K., Baschat, A. A., Deprest, J., Gratacos, E., Hecher, K., Lewi, L., Lopriore, E., Oepkes, D., Papageorghiou, A., Gordijn, S. J., Khalil, A., Baschat, A., Perales-Marin, A., Johnson, A., Silvana, A., Papageorghious, A., Khurana, A., Trinder, B., Combs, C. A., Bailie, C., Huddy, C., Bolch, C., Coutinho, C. M., Skupski, D., Hake, D., Schlembach, D., Lindahl, E., Carreras, E., Mantovani, E., Giallongo, E., Marler, E., Bertucci, E., Prefumo, F., Sileo, F. G., Guy, G., Rizzo, G., King, H., Valensise, H., Samarage, H., Duffy, J., Denton, J., Curado, J., Marsden, J., Tolosa, J. E., Toms, J., Copel, J., Richards, J., Ishii, K., Palmer, K., Watkins, K., Mcgrath, L., Canolini, L., Dhuri, M. V., Kyriakidou, M., Lanna, M., Treadwell, M., Watson, M., Rankin, M., Fenwick, N., Moore, P., O'Brien, P., Cincotta, R., Linton, S., Robinson, S., Mcsorley, T., Fuchs, T., Ghi, T., Omosebi, W., Acheampong, Y., Obstetrics and Gynaecology, Amsterdam Reproduction & Development (AR&D), APH - Digital Health, and APH - Quality of Care

Subjects
Delphi Technique, multiple pregnancy, Delphi method, Obstetric Surgical Procedures, consensus, core outcome set, Delphi consensus, fetal growth restriction, Outcome (game theory), NOMINAL GROUP TECHNIQUE, 0302 clinical medicine, Nominal group technique, Outcome Assessment, Health Care, Birth Weight, 030212 general & internal medicine, 030219 obstetrics & reproductive medicine, Fetal Growth Retardation, Radiological and Ultrasound Technology, Obstetrics and Gynecology, Gestational age, General Medicine, Treatment Outcome, PREGNANCY, Female, Live birth, Live Birth, medicine.medical_specialty, Endpoint Determination, Birth weight, Gestational Age, Likert scale, 03 medical and health sciences, medicine, Humans, Radiology, Nuclear Medicine and imaging, fetal growth restriction, multiple pregnancy, core outcome set, consensus, business.industry, Infant, Newborn, Twins, Monozygotic, Reproductive Medicine, Family medicine, Sonographer, Pregnancy, Twin, Settore MED/40 - Ginecologia e Ostetricia, business
Abstract

OBJECTIVE: Selective fetal growth restriction (sFGR) occurs in monochorionic twin pregnancies when unequal placental sharing leads to restriction in the growth of just one twin. Management options include laser separation of the fetal circulations, selective reduction or expectant management, but what constitutes the best treatment is not yet known. New trials in this area are urgently needed but, in this rare and complex group, maximizing the relevance and utility of clinical research design and outputs is paramount. A core outcome set ensures standardized outcome collection and reporting in future research. The objective of this study was to develop a core outcome set for studies evaluating treatments for sFGR in monochorionic twins. METHODS: An international steering group of clinicians, researchers and patients with experience of sFGR was established to oversee the process of development of a core outcome set for studies investigating the management of sFGR. Outcomes reported in the literature were identified through a systematic review and informed the design of a three-round Delphi survey. Clinicians, researchers, and patients and family representatives participated in the survey. Outcomes were scored on a Likert scale from 1 (limited importance for making a decision) to 9 (critical for making a decision). Consensus was defined a priori as a Likert score of ≥ 8 in the third round of the Delphi survey. Participants were then invited to take part in an international meeting of stakeholders in which the modified nominal group technique was used to consider the consensus outcomes and agree on a final core outcome set. RESULTS: Ninety-six outcomes were identified from 39 studies in the systematic review. One hundred and three participants from 23 countries completed the first round of the Delphi survey, of whom 88 completed all three rounds. Twenty-nine outcomes met the a priori criteria for consensus and, along with six additional outcomes, were prioritized in a consensus development meeting, using the modified nominal group technique. Twenty-five stakeholders participated in this meeting, including researchers (n = 3), fetal medicine specialists (n = 3), obstetricians (n = 2), neonatologists (n = 3), midwives (n = 4), parents and family members (n = 6), patient group representatives (n = 3), and a sonographer. Eleven core outcomes were agreed upon. These were live birth, gestational age at birth, birth weight, intertwin birth-weight discordance, death of surviving twin after death of cotwin, loss during pregnancy or before final hospital discharge, parental stress, procedure-related adverse maternal outcome, length of neonatal stay in hospital, neurological abnormality on postnatal imaging and childhood disability. CONCLUSIONS: This core outcome set for studies investigating the management of sFGR represents the consensus of a large and diverse group of international collaborators. Use of these outcomes in future trials should help to increase the clinical relevance of research on this condition. Consensus agreement on core outcome definitions and measures is now required. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. ispartof: ULTRASOUND IN OBSTETRICS & GYNECOLOGY vol:55 issue:5 pages:652-660 ispartof: location:England status: published

Published
2020

3. The International Network for Evaluating Outcomes (iNeo) of neonates: evolution, progress and opportunities

Author

Shah, PS, Lui, K, Reichman, B, Norman, M, Kusuda, S, Lehtonen, L, Adams, M, Vento, M, Darlow, BA, Modi, N, Rusconi, F, Hakansson, S, San Feliciano, L, Helenius, KK, Bassler, D, Hirano, S, Lee, SK, Marshall, P, Schmidt, P, Dhawan, A, Craven, P, De Waal, K, Simmer, K, Gill, A, Pillow, J, Stack, J, Birch, P, Cooke, L, Casalaz, D, Holberton, J, Stewart, A, Downe, L, Stewart, M, Bajuk, B, Berry, A, Hunt, R, Kilburn, C, De Paoli, T, Bolisetty, S, Paradisis, M, Rieger, I, Koorts, P, Kuschel, C, Numa, A, Carlisle, H, Badawi, N, Loughran-Fowlds, A, Koh, G, Davis, J, Luig, M, Andersen, C, Chambers, G, Austin, N, Lynn, A, Darlow, B, Edmonds, L, Mildenhall, L, Buksh, M, Battin, M, Van den Boom, J, Bourchier, D, Richardson, V, Dineen, F, Rajadurai, VS, Fung, G, Harrison, A, Synnes, A, Ting, J, Cieslak, Z, Sherlock, R, Yee, W, Aziz, K, Toye, J, Fajardo, C, Kalapesi, Z, Sankaran, K, Daspal, S, Seshia, M, Alvaro, R, Mukerji, A, Da Silva, O, Nwaesei, C, Lee, K-S, Dunn, M, Lemyre, B, Dow, K, Pelausa, E, Barrington, K, Drolet, C, Piedboeuf, B, Claveau, M, Beltempo, M, Bertelle, V, Masse, E, Canning, R, Mabry, H, Ojah, C, Monterrosa, L, Deshpandey, A, Afifi, J, Kajetanowicz, A, Andersson, S, Tammela, O, Sankilampi, U, Saarela, T, Prazad, P, Noguchi, A, McWan, K, Button, B, Stratton, W, Hamvus, A, Raghaven, A, Derrick, M, Hadley, R, Covert, R, Lablanc, O, Weiss, M, Bell, A, Shareef, M, Silvestri, J, Heymann, E, Zangen, S, Smolkin, T, Mimouni, F, Bader, D, Rothschild, A, Strauss, Z, Felszer, C, Oman, H, Toy-Friedman, SE, Bar-Oz, B, Feldman, M, Saad, N, Flidel-Rimon, O, Weisbrod, M, Lubin, D, Litmanovitz, I, Kngelman, A, Shinwell, E, Klinger, G, Nijim, Y, Bin-Nun, A, Golan, A, Mandel, D, Fleisher-Sheffer, V, Kohelet, D, Bakhrakh, L, Hattori, S, Shirai, M, Ishioka, T, Mori, T, Amiznka, T, Huchimukai, T, Yoshida, H, Sasaki, A, Shimizu, J, Nakamura, T, Maruyama, M, Matsumoto, H, Hosokawa, S, Taki, A, Nakagawa, M, Ko, K, Uozumi, A, Nakata, S, Shimazaki, A, Yoda, T, Numata, O, Imamura, H, Kobayashi, A, Tokuriki, S, Uchida, Y, Arai, T, Ito, M, Ieda, K, Ono, T, Hayashi, M, Maki, K, Yamakawa, M, Kawai, M, Fujii, N, Shiomi, K, Nozaki, K, Wada, H, Kim, T, Tokunaga, Y, Takatera, A, Oshima, T, Sumida, H, Michinomae, Y, Knsumoto, Y, Yoshimoto, S, Morisawa, T, Ohashi, T, Takahashi, Y, Sugimoto, M, Ono, N, Miyagawa, S, Saijo, T, Yamagami, T, Koyano, K, Kobayashi, S, Kanda, T, Sakemi, Y, Aoki, M, Iida, K, Goshi, M, Maruyama, Y, Avila-Alvarez, A, Luis Fernandez-Trisac, J, Couce Pico, ML, Fernandez Seara, MJ, Martinez Gutierrez, A, Vizcaino, C, Salvador Iglesias, M, Sanchez Zaplana, H, Fernandez Colomer, B, Garcia Lopez, JE, Garcia Mozo, R, Gonzalez Martinez, MT, Muro Sebastian, MD, Balart Carbonell, M, Badia Bamnsell, J, Domingo Puiggros, M, Figueras Aloy, J, Botet Mussons, F, Anquela Sanz, I, Ginovart Galiana, G, Coroleu, W, Iriondo, M, Vilella, LC, Porta, R, Demestre, X, Martinez Nadal, S, De Frutos Martinez, C, Lopez Cuesta, MJ, Esquivel Mora, D, Ortiz Tardio, J, Benavente, I, Alonso, A, Aguilera Olmos, R, Garcia Cabezas, MA, Martinez Jimenez, MD, Jaraba Caballero, MF, Ordofiez Diaz, MD, Fagundo, AT, Canals, LM, Garcia-Munoz Rodrigo, F, Urquia Marti, L, Moreno Galdo, MF, Hurtado Suazo, JA, Narbona Lopez, E, Uberos Fernandez, J, Cortajarena Altana, MA, Mora Navarro, D, Teresa Dominguez, M, Ruiz del Prado, MY, Esteban Diez, I, Palau Benavides, MT, Lapena, S, Prada, T, Soler Mir, E, Corredera Sanchez, A, Criado Vega, E, Del Prado, N, Fernandez, C, Cabanillas Vilaplana, L, Cuadrado Perez, I, Lopez Gomez, L, Domingo Comeche, L, Llana Martin, I, Gonzalez Armengod, C, Munoz Labian, C, Santos Munoz, MJ, Blanco Bravo, D, Perez, V, Elorza Fernandez, MD, Diaz Gonzalez, C, Ares Segura, S, Lopez Azorin, M, Belen Jimenez, A, Sanchez-Tamayo, T, Tapia Moreno, E, Gonzalez, M, Sanchez Martinez, JE, Lloreda Garcia, JM, Goni Orayen, C, Vilas Gonzalez, J, Suarez Albo, M, Gonzalez Colmenero, E, Gutierrez Gonzalez, EP, Vacas del Arco, B, Marquez Fernandez, J, Acosta Gordillo, L, Granero Asensio, M, Macias Diaz, C, Albujar, M, Fuster Jorge, P, Romero, S, Rivero Falero, M, Escobar Izquierdo, AB, Estan Capell, J, Izquierdo Macian, MI, Montejo Vicente, MM, Izquierdo Caballero, R, Mercedes Martinez, M, Euba, A, Rodriguez Serna, A, De Heredia Goya, JML, Perez Legorburu, A, Gutierrez Amoros, A, Marugan Isabel, VM, Hernandez Gonzalez, N, Rite Gracia, S, Ventura Faci, MP, Samper Villagrasa, MP, Kofron, J, Brodd, KS, Odlind, A, Alberg, L, Arwehed, S, Hafstrom, O, Kasemo, A, Nederman, K, Ahman, L, Ingemarsson, F, Petersson, H, Thum, P, Albinsson, E, Selander, B, Abrahamsson, T, Heimdahl, I, Sveinsdottir, K, Wejryd, E, Hedlund, A, Soderberg, MK, Hallberg, B, Brune, T, Backstrom, J, Robinson, J, Farooqi, A, Normann, E, Fredriksson, M, Palm, A, Rosenqvist, U, Hagman, C, Ohlin, A, Floral, R, Smedsaas-Lofvenberg, A, Meyer, P, Anderegg, C, Schulzke, S, Nelle, M, Wagner, B, Riedel, T, Kaczala, G, Walde, B, Pfister, RE, Tolsa, J-F, Roth, M, Stocker, M, Laubscher, B, Malzacher, A, Micallef, JP, Hegi, L, Arlettaz, R, Bernet, V, Dani, C, Fiorini, P, Boldrini, A, Tomasini, B, Mittal, A, Kefas, J, Kamalanathan, A, Jayachandran, Yoxall, B, McBride, T, Webb, D, Garr, R, Hassan, A, Ambadkar, P, Dyke, M, McDevitt, K, Rewitzky, G, D'Amore, A, Panasa, N, Settle, P, Maddock, N, Edi-Osagie, N, Zipitis, C, Heal, C, Birch, J, Hasib, A, Soe, A, Kumar, N, Kisat, H, Vasu, V, Lama, M, Gupta, R, Rawlingson, C, Wickham, T, Theron, M, Kendall, G, Gupta, A, Aladangady, N, Ali, I, Alsford, L, Lopez, W, Murthy, V, Sullivan, C, Thomas, M, Bate, T, Godambe, S, Watts, T, Kuna, J, Chang, J, Pai, V, Huddy, C, Yasin, S, Nicholl, R, Pandey, P, Kairamkonda, V, Muogbo, D, Harry, L, Simmons, P, Nycyk, J, Gallagher, A, Pillay, T, Deshpande, S, Mahadevan, Moore, A, Clark, S, Garbash, M, Lal, M, Abu-Harb, M, Allwood, A, Selter, M, Munyard, P, Bartle, D, Paul, S, Whincup, G, Mallik, A, Amess, P, Godden, C, Reynolds, P, Misra, I, De Halpert, P, Salgia, S, Sanghavi, R, Wigfield, R, Deketelaere, A, Khashu, M, Hall, M, Groves, C, Brown, N, Brennan, N, Vamvakiti, K, McIntyre, J, Pirie, S, Jones, S, Mannix, P, Cairns, P, Eaton, M, Schwarz, K, Gibson, D, Miall, L, Krishnamurthy, University of Zurich, Shah, Prakesh S, Canadian Institutes of Health Research (CIHR), and Neonid NPO

Subjects
medicine.medical_specialty, NEW-ZEALAND, Population, 610 Medicine & health, RETINOPATHY, Review Article, Audit, Pediatrics, outcomes research, MORBIDITY, Nursing, neonatal intensive care, Health care, medicine, LOW-BIRTH-WEIGHT, 2735 Pediatrics, Perinatology and Child Health, education, education.field_of_study, Science & Technology, EXTREMELY PRETERM INFANTS, business.industry, MORTALITY, Public health, Health services research, Preterm infants, Capacity building, BRONCHOPULMONARY DYSPLASIA, Benchmarking, 10027 Clinic for Neonatology, INTENSIVE-CARE UNITS, TRENDS, CANADA, Pediatrics, Perinatology and Child Health, Outcomes research, business, Life Sciences & Biomedicine
Abstract

Neonates born very preterm (before 32 weeks’ gestational age), are a significant public health concern because of their high-risk of mortality and life-long disability. In addition, caring for very preterm neonates can be expensive, both during their initial hospitalization and their long-term cost of permanent impairments. To address these issues, national and regional neonatal networks around the world collect and analyse data from their constituents to identify trends in outcomes, and conduct benchmarking, audit and research. Improving neonatal outcomes and reducing health care costs is a global problem that can be addressed using collaborative approaches to assess practice variation between countries, conduct research and implement evidence-based practices. The International Network for Evaluating Outcomes (iNeo) of neonates was established in 2013 with the goal of improving outcomes for very preterm neonates through international collaboration and comparisons. To date, 10 national or regional population-based neonatal networks/datasets participate in iNeo collaboration. The initiative now includes data on >200,000 very preterm neonates and has conducted important epidemiological studies evaluating outcomes, variations and trends. The collaboration has also surveyed >320 neonatal units worldwide to learn about variations in practices, healthcare service delivery, and physical, environmental and manpower related factors and support services for parents. The iNeo collaboration serves as a strong international platform for Neonatal-Perinatal health services research that facilitates international data sharing, capacity building, and global efforts to improve very preterm neonate care.

Published
2019

4. The INNOVO multicentre randomised controlled trial: neonatal ventilation with inhaled nitric oxide versus ventilatory support without nitric oxide for severe respiratory failure in preterm infants: follow up at 4-5 years

Author

Huddy, C, Bennett, C, Hardy, P, Field, D, Elbourne, D, Grieve, R, Truesdale, A, Diallo, K, and Grp, I

Subjects
Pediatrics, medicine.medical_specialty, Clinical effectiveness, Developmental Disabilities, Infant, Premature, Diseases, Nitric Oxide, Nitric oxide, law.invention, chemistry.chemical_compound, Disability Evaluation, Randomized controlled trial, law, Administration, Inhalation, medicine, Humans, Trial registration, Inhalation, business.industry, Neonatal ventilation, Infant, Newborn, Obstetrics and Gynecology, General Medicine, Health Care Costs, Combined Modality Therapy, Respiration, Artificial, Bronchodilator Agents, Treatment Outcome, Respiratory failure, chemistry, Pediatrics, Perinatology and Child Health, Outcome data, business, Respiratory Insufficiency, Infant, Premature, Follow-Up Studies
Abstract

BACKGROUND: Trials of inhaled nitric oxide (iNO) used short term in preterm infants with severe respiratory failure have to date shown no evidence of benefit, and there have been no trials reporting follow-up to 4 years of age. The INNOVO trial recruited 108 infants (55 iNO arm and 53 controls) from 15 neonatal units. By 1 year of age 59% had died, and 84% of the survivors had signs of impairment or disability. OBJECTIVE: This paper reports the long-term clinical effectiveness and costs of adding NO to the ventilator gases of preterm infants with severe respiratory failure. PATIENTS AND METHODS: Children were assessed at age 4-5 years by interview, examination, cognitive and behavioural assessments. The outcome data were divided into seven domains and were described as normal, impaired or disabled (mild, moderate or severe) by the degree of functional loss. RESULTS: 38 of the 43 survivors had follow-up assessments. In the iNO group 62% (34/55) had died or were severely disabled, compared to 70% (37/53) in the no iNO group (RR 0.89, 95% CI 0.67 to 1.16). There was no evidence of difference in the levels of impairment or disability between the two groups in any of the domains studied, or of cost differences, amongst the survivors. CONCLUSION: For this group of babies with severe respiratory failure there was no evidence of difference in the longer-term outcome between those babies allocated to iNO and those who were allocated to no iNO. The challenge is to identify those premature babies who are able to respond to NO with clinically important health improvements. TRIAL REGISTRATION NUMBER: 17821339.

Published
2016

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