Journal of perinatology : official journal of the California Perinatal Association · 2026
Randomized pilot study comparing standard vs high-calorie feeding in infants with Neonatal Opioid Withdrawal Syndrome.
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Cheng Frances Y, Tuttle McKenzie, Dionne Elyssa, Shabanova Veronika, McCollum Sarah, Morrison Alyssa, McMillan Chandler J, Anyoha Sandra N, Swerling Lynda S, Petrucelli Amy, Lary Lauren K, Fulton Kristen, Abeyaratne Dhatri, Wang Grace, Hodelin Christine, Elmansy Lina A, Carlson Kailey, Shapiro Eugene D, Grossman Matthew R
Аннотация
OBJECTIVE: We assessed feasibility of high-calorie feeds in infants with NOWS at risk for excessive weight loss managed using Eat, Sleep, Console.
STUDY DESIGN: In this double-blind pilot study (NCT04419857, Connecticut, USA), we randomized methadone- or buprenorphine-prenatally-exposed infants <48 h old to standard- or high-calorie feeds. Primary outcomes were enrollment, adherence, and retention; exploratory outcomes included breastfeeding and stooling frequency.
RESULTS: From December 2020 to August 2023, 35/65 infants (53.8%) were randomized. During hospitalization, 84% of feeds adhered to the randomized feeding approach. In-hospital retention was 71.4%; 14-day post-discharge retention was 28.6%. Groups did not differ significantly in demographic characteristics, maximum percent weight loss (p = 0.12), length of stay (p = 0.88), or stool frequency (p = 0.59). High-calorie-fed infants more frequently received breastmilk at discharge (p = 0.04).
CONCLUSION: Enrollment, adherence, and in-hospital retention were comparable to other feasibility trials; post-discharge follow-up was poor. Early high-calorie feeding did not appear to be negatively associated with breastfeeding or stooling.
STUDY DESIGN: In this double-blind pilot study (NCT04419857, Connecticut, USA), we randomized methadone- or buprenorphine-prenatally-exposed infants <48 h old to standard- or high-calorie feeds. Primary outcomes were enrollment, adherence, and retention; exploratory outcomes included breastfeeding and stooling frequency.
RESULTS: From December 2020 to August 2023, 35/65 infants (53.8%) were randomized. During hospitalization, 84% of feeds adhered to the randomized feeding approach. In-hospital retention was 71.4%; 14-day post-discharge retention was 28.6%. Groups did not differ significantly in demographic characteristics, maximum percent weight loss (p = 0.12), length of stay (p = 0.88), or stool frequency (p = 0.59). High-calorie-fed infants more frequently received breastmilk at discharge (p = 0.04).
CONCLUSION: Enrollment, adherence, and in-hospital retention were comparable to other feasibility trials; post-discharge follow-up was poor. Early high-calorie feeding did not appear to be negatively associated with breastfeeding or stooling.