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Randomized Controlled Trial
. 2024 Oct 1;178(10):976-984.
doi: 10.1001/jamapediatrics.2024.2578.

Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial: A Secondary Analysis of a Randomized Clinical Trial

Stephanie L Merhar  1   2 , Zhuopei Hu  3 , Lori A Devlin  4 , Songthip T Ounpraseuth  3 , Alan E Simon  5   6 , P Brian Smith  7 , Michele C Walsh  8 , Jeannette Y Lee  3 , Abhik Das  9 , Rosemary D Higgins  10 , Margaret M Crawford  9 , Ward Rice  1   2   11 , David A Paul  12 , Jessie R Maxwell  13 , Sucheta D Telang  4 , Camille M Fung  14 , Tanner Wright  15 , Anne-Marie Reynolds  16 , Devon Hahn  17 , Julie Ross  18 , Jennifer M McAllister  1 , Moira Crowley  19 , Sophie K Shaikh  20 , Lori Christ  21 , Jaime Brown  22 , Julie Riccio  23 , Kara Wong Ramsey  24 , Erica F Braswell  25 , Lauren Tucker  26 , Karen McAlmon  27 , Krishna Dummula  28 , Julie Weiner  29 , Jessica R White  30 , Meghan P Howell  31 , Sarah Newman  32 , Jessica N Snowden  33 , Leslie W Young  34 ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Tri; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Trials Network
Collaborators, Affiliations
Randomized Controlled Trial

Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial: A Secondary Analysis of a Randomized Clinical Trial

Stephanie L Merhar et al. JAMA Pediatr. .

Abstract

Importance: Infants with neonatal opioid withdrawal syndrome (NOWS) cared for with the Eat, Sleep, Console (ESC) care approach receive less pharmacologic treatment and have shorter hospital stays compared to usual care with the Finnegan Neonatal Abstinence Scoring Tool, but the effects of these approaches on feeding and weight are unknown.

Objective: To evaluate feeding practices and weight trajectories in infants cared for with ESC vs usual care.

Design, setting, and participants: ESC-NOW is a cluster randomized trial of infants with NOWS born at 36 weeks' gestation or later at 26 US hospitals from September 2020 to March 2022. Each site transitioned from usual care to ESC (the study intervention) at a randomized time. Feeding was per site practice and not specified by the intervention. Feeding and weight outcomes were assessed at hospital discharge.

Intervention: ESC vs usual care.

Main outcomes and measures: Outcomes include prospectively identified secondary end points related to feeding and weight. z Scores were used for growth to account for corrected gestational age at the time of measurement. All analyses were intention to treat and adjusted for study design. Maternal/infant characteristics were included in adjusted models.

Results: The analyses included 1305 infants (702 in usual care and 603 in ESC; mean [SD] gestational age, 38.6 [1.3] weeks; 655 [50.2%] male and 650 [49.8%] female). Baseline demographic characteristics were similar between groups. The proportion of breastfed infants was higher in the ESC group (52.7% vs 41.7%; absolute difference, 11%; 95% CI, 1.0-20.9). A higher proportion of infants cared for with ESC received exclusive breast milk (15.1% vs 6.7%; absolute difference, 8.4%; 95% CI, 0.9-5.8) or any breast milk (38.8% vs 27.4%; absolute difference, 11.4%; 95% CI, 0.2-23.1) and were directly breastfeeding at discharge (35.2% vs 19.5%; absolute difference, 15.7%; 95% CI, 4.1-27.3). There was no difference in proportion of infants with weight loss greater than 10% or maximum percentage weight loss, although infants cared for with ESC had a lower weight z score on day of life 3 (-1.08 vs -1.01; absolute difference, 0.07; 95% CI, 0.02-0.12). When pharmacologic treatment was added into the model, no breastfeeding outcomes were statistically significant.

Conclusions and relevance: In this study, infants cared for with ESC were more likely to initiate and continue breastfeeding and had no difference in percentage weight loss. The improvement in breastfeeding with ESC may be driven by reduction in pharmacologic treatment and provision of effective nonpharmacologic care.

Trial registration: ClinicalTrials.gov Identifier: NCT04057820.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Devlin reported grants from the National Institutes of Health Helping to End Addiction Long-term Initiative during the conduct of the study and outside the submitted work. Dr Ounpraseuth reported grants from the National Institutes of Health Helping to End Addiction Long-term Initiative during the conduct of the study. Dr Simon conducted this work when he was part of the Environmental Influences on Child Health Outcomes program. Dr Walsh reported grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (employed as a project scientist) and fees from Elsevier for editing Fanaroff and Martin's Neonatal Perinatal Medicine textbook during the conduct of the study. Dr Lee reported grants from the National Institutes of Health during the conduct of the study. Dr Das reported grants from the National Institutes of Health during the conduct of the study. Dr Higgins reported other from National Institutes of Health former employee during the conduct of the study. Dr Crawford reported grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development during the conduct of the study. Dr Paul reported grants from the Institutional Development Awards States Pediatric Trial Network during the conduct of the study. Dr Fung reported grants from the University of Utah during the conduct of the study. Dr Reynolds reported grants from the National Institutes of Health during the conduct of the study. Dr Ross reported grants from the Helping to End Addiction Long-term Initiative of National Institutes of Health during the conduct of the study. Dr Shaikh reported grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development during the conduct of the study. Dr McAlmon reported grants from the National Institutes of Health during the conduct of the study. Dr Dummula reported grants from the National Institutes of Health during the conduct of the study. Dr Weiner reported grants from the National Institutes of Health during the conduct of the study. Dr White reported grants from the National Institutes of Health/Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network during the conduct of the study. Dr Howell reported grants from the National Institutes of Health/Environmental Influences on Child Health Outcomes during the conduct of the study. Dr Snowden reported grants from the National Institutes of Health during the conduct of the study as well as personal fees from Pfizer (advisory board; ended November 2023, not related to this work) outside the submitted work. Dr Young reported grants from the National Institutes of Health during the conduct of the study. No other disclosures were reported.

Figures

Figure.
Figure.. CONSORT Flow Diagram of Participants Throughout the Eat, Sleep, Console (ESC) Trial
NOWS indicates neonatal opioid withdrawal syndrome.
See this image and copyright information in PMC

References

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