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Abstract Background With increased use of telehealth, interventions to improve infant sleep environments have not been explored. This study sought to assess the feasibility and efficacy of using electronic health record patient portals to transmit photographs of infant sleep between mothers and healthcare professionals as part of an intervention to promote sleep environments consistent with AAP guidelines. Methods One hundred eighty-four mother-newborn dyads consented to participate in a randomized trial requiring patient portal registration within 1 month of delivery. We first assessed feasibility as measured by a) the proportion of consented mothers enrolling in the portal and b) maternal adherence to prompts to submit photographs of their infant sleeping to the research team through the patient portal. Intervention group mothers were prompted at 1 and 2 months; controls were prompted only at 2 months. Efficacy was determined via research assistant review of submitted photographs. These assistants were trained to detect sudden unexplained infant death risk factors utilizing AAP guidelines. Standardized feedback was returned to mothers through the patient portal. We used Fisher’s Exact test to assess group differences in guideline adherence at 2 months. Results One hundred nine mothers (59%) enrolled in the patient portal and were randomized to intervention (N = 55) and control (N = 54) groups. 21 (38, 95% CI 25–52%) intervention group participants sent photographs at 1 month and received personalized feedback. Across both groups at 2 months, 40 (37, 95% CI 28–46%) sent photographs; 56% of intervention group participants who submitted photographs met all safe sleep criteria compared with 46% of controls (difference 0.10, 95% CI − 0.26 to 0.46, p = .75). Common reasons for guideline non-adherence were sleeping in a room without a caregiver (43%), loose bedding (15%) and objects (8%) on the sleep surface. Conclusions Utilizing the patient portal to individualize safe infant sleep is possible, however, we encountered numerous barriers in this trial to assess its effects on promoting safe infant sleep. Photographs of infants sleeping showed substantial non-adherence to AAP guidelines, suggesting further needs for improvement to promote safe infant sleep practices. Trial registration Name: Improving Infant Sleep Safety With the Electronic Health Record; Clinicaltrials.gov: NCT03662048 ; Date of Registration: September 7, 2018; Data Sharing Statement: None

Abstract Background Weight is critical for the medical management of infants; however, scales can be unavailable or inaccessible in some practice settings. We recently developed and validated a robust infant weight estimation method based on chest circumference (CC) and head circumference (HC). This study was designed to determine the human factors (HF) experience with, and predictive performance of, an infant weight estimation device that implements this method. Methods Prospective, multi-center, observational, masked study of 486 preterm and term infants (0–90 days) assessed by 15 raters. Raters measured the infant using calibrated scales/measures and masked versions of the device. Raters also evaluated critical tasks associated with device use. Mean error (ME) and mean percentage error (MPE) were used to assess predictive performance. Result Among 486 infants enrolled (36.8 ± 4.0 weeks gestational age, 31.5 ± 28.6 days postnatal age), predicted weight correlated highly with actual weight (r = 0.97, ME: − 69 ± 257 g, MPE: − 1.3 ± 6.9%). Predicted weight was within 10 and 15% of actual weight in 86 and 99%, of infants. HF errors were low, 0.1–0.8% depending on task. In all cases raters were confident or very confident in their measurements. Conclusion The device was statistically equivalent to the method on which it was based and approximated weight with acceptable variance from the true weight. HF data suggest the device is easy to use. This device can be used to estimate weight in infants when calibrated scales are impractical or unavailable.

Abstract Background Use of food to soothe infant distress has been linked to greater weight in observational studies. We used ecological momentary assessment to capture detailed patterns of food to soothe and evaluate if a responsive parenting intervention reduced parents’ use of food to soothe. Methods Primiparous mother-newborn dyads were randomized to a responsive parenting intervention designed for obesity prevention or a safety control group. Responsive parenting curriculum included guidance on using alternative soothing strategies (e.g., swaddling), rather than feeding, as the first response to infant fussiness. After the initial intervention visit 3 weeks after delivery, mothers (n = 157) were surveyed for two 5–8 day bursts at infant ages 3 and 8 weeks. Surveys were sent via text message every 4 h between 10:00 AM-10:00 PM, with 2 surveys sent at 8:00 AM asking about nighttime hours. Infant fusses and feeds were reported for each 4-h interval. Food to soothe was defined as “Fed First” and “Not Fed First” in response to a fussy event. Use of food to soothe was modeled using random-intercept logistic regression. Results The control group had greater odds of having Fed First, compared to the responsive parenting group at ages 3 and 8 weeks (3 weeks: OR = 1.9; 95% CI = 1.4–2.7; p

Abstract Background The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System. Methods The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical literature, manufacturer postmarket safety databases, and news/media reports to identify cases from January 2008 through September 2016. Each data source was evaluated by the proportion of detected cases determined to be eligible (met case criteria) and the proportion determined to be evaluable (able to determine causal relationship between adverse event and exposure). Results A total of 7184 unique cases were identified from 27,597 detected reports. Of these, 6447 (89.7%) were evaluable. The data source with the highest volume of detected cases was news/media; however, only 0.3% of those cases were eligible for panel review and only 0.2% (24 out of 13,450 cases) were evaluable. The data source with the highest proportion of eligible and evaluable cases was NPDS with 7691 detected cases, 6113 (79.5%) eligible cases, and 5587 (72.6%) evaluable cases. Conclusions The data sources utilized to evaluate the safety profile of pediatric CCMs yielded variable detection and evaluation rates, but overall provided a comprehensive look at exposures that otherwise cannot be studied in clinical trials. While this study suggests that each source made a valuable contribution and that evaluable cases are generalizable, improvements are needed in case completeness and accuracy to enhance the quality of postmarket safety evaluations.

Abstract Background Infants with neonatal abstinence syndrome (NAS) initially experience neurologic excitability, poor feeding, and/or hyperphagia in the setting of increased metabolic demand. Because the longitudinal effects of these early symptoms and behaviors on weight trends are unknown, we sought to contrast weight gain patterns through age 1 year for infants diagnosed with NAS with matched controls. Methods Retrospective cohort of 70 singletons with a gestational age of ≥37 weeks and an ICD-9 or ICD-10 diagnosis of NAS made ≤7 days after birth with institutional follow-up matched to patients without NAS. Infants were matched on gestational age (±2 weeks), birth weight (±20 g), sex (exact), and insurance type (exact). Quantile regression methods were used to estimate 10th, 25th, 50th, 75th and 90th percentiles of weight over time. Results The mean gestational age for an infant with NAS was 38.8 weeks (standard deviation [SD], 1.3). The mean birth weight was 3.141 kg (SD, 0.510). NAS patients had a median of 24 weights recorded between birth and 400 days (inter-quartile range [IQR], 16–32 weights). Patients without NAS had a median of 12 weights recorded (IQR, 10–16). Growth curves were similar over the first 400 days of life. Patients with NAS had non-significantly higher and lower estimated weights for the 90th and 10th percentiles, respectively. Conclusion Infants with a diagnosis of NAS grew similarly to controls during their first year. Given the frequently-encountered NAS symptoms of hyperphagia and irritability, future studies may evaluate whether early differences in caregiver feeding exist and whether they have longer-term impacts on growth.

Abstract Background Economically disadvantaged families receive care in both clinical and community settings, but this care is rarely coordinated and can result in conflicting educational messaging. WEE Baby Care is a pragmatic randomized clinical trial evaluating a patient-centered responsive parenting (RP) intervention that uses health information technology (HIT) strategies to coordinate care between pediatric primary care providers (PCPs) and the Special Supplemental Nutrition Program for Women, Infant and Children (WIC) community nutritionists to prevent rapid weight gain from birth to 6 months. It is hypothesized that data integration and coordination will improve consistency in RP messaging and parent self-efficacy, promoting shared decision making and infant self-regulation, to reduce infant rapid weight gain from birth to 6 months. Methods/design Two hundred and ninety mothers and their full-term newborns will be recruited and randomized to the “RP intervention” or “standard care control” groups. The RP intervention includes: 1) parenting and nutrition education developed using the American Academy of Pediatrics Healthy Active Living for Families curriculum in conjunction with portions of a previously tested RP curriculum delivered by trained pediatric PCPs and WIC nutritionists during regularly scheduled appointments; 2) parent-reported data using the Early Healthy Lifestyles (EHL) risk assessment tool; and 3) data integration into child’s electronic health records with display and documentation features to inform counseling and coordinate care between pediatric PCPs and WIC nutritionists. The primary study outcome is rapid infant weight gain from birth to 6 months derived from sex-specific World Health Organization adjusted weight-for-age z-scores. Additional outcomes include care coordination, messaging consistency, parenting behaviors (e.g., food to soothe), self-efficacy, and infant sleep health. Infant temperament and parent depression will be explored as moderators of RP effects on infant outcomes. Discussion This pragmatic patient-centered RP intervention integrates and coordinates care across clinical and community sectors, potentially offering a fundamental change in the delivery of pediatric care for prevention and health promotion. Findings from this trial can inform large scale dissemination of obesity prevention programs. Trial registration Restrospective Clinical Trial Registration: NCT03482908. Registered March 29, 2018.

Abstract Background What, when, how, how much, and how often infants are fed have been associated with childhood obesity risk. The objective of this secondary analysis was to examine the effect of a responsive parenting (RP) intervention designed for obesity prevention on parents’ infant feeding practices in the first year after birth. Methods Primiparous mother-newborn dyads were randomized to the Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study RP intervention or child safety control. Research nurses delivered intervention content at home at infant age 3–4, 16, 28, and 40 weeks, and at a research center at 1 year. RP feeding guidance advised feeding that was contingent (i.e., feed in response to hunger and satiety signs, alternatives to using food to soothe), and developmentally appropriate (i.e., delaying introduction of solids, age-appropriate portion sizes). Infant feeding practices (i.e., bottle use, introduction of solids, food to soothe) were assessed by phone interviews and online surveys and dietary intake was assessed using a food frequency questionnaire. Results RP mothers were more likely to use of structure-based feeding practices including limit-setting (p

Abstract Background Sedentary behaviors, including screen time, in childhood have been associated with an increased risk for overweight. Beginning in infancy, we sought to reduce screen time and television exposure and increase time spent in interactive play as one component of a responsive parenting (RP) intervention designed for obesity prevention. Methods The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study is a randomized trial comparing a RP intervention with a safety control intervention. Primiparous mother-newborn dyads (N = 279) were randomized after childbirth. Research nurses delivered intervention content at infant ages 3, 16, 28, and 40 weeks and research center visits at 1 and 2 years. As one component of INSIGHT, developmentally appropriate messages on minimizing screen time, reducing television exposure in the home, and promoting parent-child engagement through interactive play were delivered. Mothers self-reported their infant’s screen time at ages 44 weeks, 1, 1.5, 2 and 2.5 years; interactive play was reported at 8 and 20 weeks and 2 years. Results More RP than control parents reported their infants met the American Academy of Pediatrics’ no screen time recommendation at 44 weeks (53.0% vs. 30.2%) and at 1 year on weekdays (42.5% vs. 27.6%) and weekends (45.5% vs. 26.8%), but not after age 1 year. RP mothers and RP children had less daily screen time than controls at each time point (p ≤ 0.01). Fewer RP than control group mothers reported the television was ever on during infant meals (p

An amendment to this paper has been published and can be accessed via the original article.