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Randomized Controlled Trial
. 2018 Jan;8(1):7-14.
doi: 10.1542/hpeds.2017-0114.

Randomized Clinical Trial of Standard- Versus High-Calorie Formula for Methadone-Exposed Infants: A Feasibility Study

Debra L Bogen  1 , Barbara H Hanusa  2 , Robyn Baker  3   4 , Barbara Medoff-Cooper  5 , Barbara Cohlan  3   4
Affiliations
Randomized Controlled Trial

Randomized Clinical Trial of Standard- Versus High-Calorie Formula for Methadone-Exposed Infants: A Feasibility Study

Debra L Bogen et al. Hosp Pediatr. 2018 Jan.

Abstract

Background: Newborns who are prenatally exposed to methadone are at risk for neonatal abstinence syndrome and the associated excess weight loss and poor weight gain. This pilot feasibility study aimed to evaluate early caloric enhancement on weight patterns among infants born to women receiving methadone maintenance therapy while pregnant.

Methods: In this double-blind pilot feasibility study, we randomly assigned infants with fetal methadone exposure to 24 or 20 kcal/oz formula from days 3 to 21. Randomization was stratified by any breastfeeding, sex of the infant, and gestational age. Eligible infants were ≥35 weeks' gestation and weighed ≥2200 g. Outcomes were days to weight nadir, maximum percent weight loss, days to birth weight, percentage weight change per day, and feasibility.

Results: A total of 49 infants were randomly assigned (22 to standard- and 27 to high-calorie formula); groups had comparable demographic characteristics. Main outcomes comparing standard- to high-calorie formula groups were not significant (days to weight nadir, 5.0 vs 4.4 days; P = .20; maximum percent weight loss, -9.4% vs -8.6%; P = .15; days to birth weight, 14.7 vs 13.6 days; P = .07); however, in longitudinal analyses (days 4 to 21), the high-calorie group had a higher percent weight gained per day compared with the standard-calorie group (P <.001). There were high levels of protocol adherence, and no adverse effects were observed.

Conclusions: Study findings suggest that early initiation of high-calorie formula for infants with prenatal methadone exposure may be beneficial for weight gain; evaluation in a larger study is warranted.

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Conflict of interest statement

POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

Figures

FIGURE 1
FIGURE 1
Consort diagram. MWH, Magee-Womens Hospital.
FIGURE 2
FIGURE 2
Results of the longitudinal analyses of weight change over time for infants in the 2 treatment groups. The lines represent the mean percent weight gain, and the shaded areas are the 95% confidence intervals of the lines. The differences in the 2 lines are a function of days; the lines diverge more as the days increase, which necessitates a day-squared term. The increase in percent weight gain between days 4 and 21 was estimated by −12% + 0.62% × day + 0.02% × day2 for the standard-calorie group and by −9% + 0.01% × day + 0.06 × day2 for the high-calorie group. Overall, the model with treatment, day and day2, and the interactions of treatment by day and treatment by day2 has a χ2 (degrees of freedom = 5) of 4316.67 and a P value <.001. All individual terms and interactions had a P value <.08.
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Comment in

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