Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial
Authors: Merhar Stephanie L. , Hu Zhuopei , Devlin Lori A. , Ounpraseuth Songthip T. , Simon Alan E. , Smith P. Brian , Walsh Michele C. , Lee Jeannette Y. , Das Abhik , Higgins Rosemary D. , Crawford Margaret M. , Rice Ward , Paul David A. , Maxwell Jessie R. , Telang Sucheta D. , Fung Camille M. , Wright Tanner , Reynolds Anne-Marie , Hahn Devon , Ross Julie , McAllister Jennifer M. , Crowley Moira , Shaikh Sophie K. , Christ Lori , Brown Jaime , Riccio Julie , Wong Ramsey Kara , Braswell Erica F. , Tucker Lauren , McAlmon Karen , Dummula Krishna , Weiner Julie , White Jessica R. , Howell Meghan P. , Newman Sarah , Snowden Jessica N. , Young Leslie W. ,   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, Hubberd De Ann , Edwards Kathy , Whalen Bonny L. , MacMillan Kate , Pahl Adrienne , Sheehan Desselle Farrah , White Katie , Hibbs Anna Marie , Clarke Leslie , Serio Kathy , Kertesz Maria , Rodriguez Ashley , Driscoll Sarah , Hammond Kim , Hines Deborah , Kish Patricia , Schmidt Taylor , Stepp Jennifer , Jackson Jodi , Scott Allie , Brown Rochelle , Smith Kari , Rieper My , Miner Carrie , Ray Lynne , Kowel Karen , Reynolds Victoria , Castellone Diana , Mackley Amy , Schibler Kurt , Beiersdorfer Traci , Grisby Cathy , Kirker Kristin , McKeown Katherine , Loudermilk M. Katherine , Carnohan Amy , Froese Patti , Haddix April , Summe Virginia , Chlon Clara , Kunk Rita , Hamilton Jen , Moore Sadie , Ziegelmeyer Angela , Rolfes Lucy , Schomaker Erica , Strike Holly , Harvey Sharon , Richards Paula , Simon Ashley , Russell David , Gleason Christine A. , Allen Marilee C. , Boyle Robert J. , Clemons Traci , D’Alton Mary E. , Steinhorn Robin , Weiner Steven J. , Blaisdell Carol J. , Wilson Archer Stephanie , Amiotte Annette , Santos Moara , Taosaka Jill , Neal Charles , Atz Andrew M. , Summer Andrea , Amaya Michelle , Freeman Mary , Johnson Madison , Sarraf Layla Al , Ros-Demarize Rosemary , Sánchez Pablo J. , Slaughter Jonathan L. , Benninger Kristen , Luzader Patricia , Marzec Laura , DeSantis Brittany , Small Kristi , Newton Julia , Purnell Jessica , Reedy Rachel , Hanlon Cory , Naik Tanvi , Knox Jordan , Tallikar Aishwarya , Cobe Chelsea , Resetar Megan , McCool Jacqueline , Frailey Erin , Jones Stephanie , Williams Stacy , Staton Taise , Palmer Jacqueline N. , Erner Jana L. , Kovalcik Jason B. , Keels Erin L. , McCarty Teri , Harris Katherine , DeSpain Meagan , Boyd Jackie , Watson Sara , Sullivan Jan , Walsh Timothy , Anderson Brianna , Hahn Devon , Madden Christi , Nascimbeni Anne , Wilson Shannon , Gibson Theresa , Karlin John , Bann Carla M. , O’Donnell Auman Jeanette , Turner Eugene , Smith Emily , Bradley Lauren , Trochinski Lillian , Gabrio Jenna , Leblond David , Pickett James , Newman Jamie E. , Zaterka-Baxter Kristin M. , Baack Michelle L. , Hogden Laurie A. , Elenkiwich Chelsey , Henning Megan M. , Van Muyden Sarah , Martino Anna-Lisa , Lutz Allison , Nelson Jeralyn , Schumacher Bette , Brodkorb Aimee , Pritchett Deborah , Ford Kristen , Howard Darla , Orland Ryan , Diles Monique , Shuttleworth Kay L. , Hubberd DeAnn E. , Edwards Kathy D. , Lloyd Sherry L. , Banks-Johnson Catrice , Robinson Patrina , Griffith Melissa , Slaughter Amie , Kilkenny Teresa , Foster Kristina , Cross Morgan , Gier Jessica , Roberts Natalie , Wadman Jessica , Cathey Kathy , Todd Jenna , Fratesi Emily , Malloch Lacy , Alur Radha , Majure Joseph Marc , Walker Courtney , Powers Catherine , Annett Robert D. , Wellman Rachel , Miller Kerry , Anderson-Berry Ann , Raissy Hengameh , Kong Alberta , McCalmont Kate , Sundquist Beauman Sandra , Sanders Sarah , Eichenwald Eric C. , Mancini Toni , Ziolkowski Kristina , Dhawan Megan , Gambacorta Mary Kay , Pulsifer Allie , Brant Marisa , Schumacher Aida , Gocial Sydney , Azuma Kristen , Quigley Elizabeth , Zachritz Whitney , Pastore Nicole , Barber Jessica , McDowell Abby , Ferri Alissa , Parga-Belinkie Joanna , Guillet Ronnie , Jensen Rosemary L. , Kent Alison , Scorsone Ann Marie , Lakshminrusimha Satyan , Hartley-McAndrews Michelle E. , Li Emily , Donato Jennifer , McKee Kimberly G. , D’Angio Carl , Jones Rachel , Terrano Dacia , Solpietro Stephanie , Brei Lisa , Krokovich Lisa , Hart Sema , Pastore John , Kern Ashley , Mars Margaret , Volker Patricia , Mioneo Brady Annette , Voelker Kelsey , Horn Emily , Moreland Melissa , Kneusel Marcia , Balakrishnan Maya , Childres Jillian , Hanniman Melissa , White Rebecca , Ohls Robin K. , Baserga Mariana , Muniyappa Bhanu , Shakib Julie , Rau Carrie A. , Baker Shawna , Coleman Kathie , McGrath Kandace M. , Petersen Brandy , Waldvogel Jael , Bracken Monika , Ferrin Meredith , DeSantis Holly , Perkins Traci , Loertscher Manndi C. , McAlmon Karen , Goldstein Justin , Angelidou Asimenia , Donahue Nancy 
Published: August 2024

ImportanceInfants 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.ObjectiveTo evaluate feeding practices and weight trajectories in infants cared for with ESC vs usual care.Design, Setting, and ParticipantsESC-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.InterventionESC vs usual care.Main Outcomes and MeasuresOutcomes 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.ResultsThe 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 RelevanceIn 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 RegistrationClinicalTrials.gov Identifier: NCT04057820