Energy‐ and protein‐enriched formula improves weight gain in infants with malnutrition due to cardiac and noncardiac etiologies

BACKGROUND: We aimed to assess safety, tolerability, and improvement in weight gain with an energy‐ and protein‐enriched formula (EPEF) in infants with poor growth. METHODS: Infants aged 1–8 months with poor growth received EPEF for 16 weeks. Our primary objective was improvement in weight as measured by change in weight‐for‐age z‐score (WAZ) and weight gain velocity (grams per day) ≥ median for age. Secondary objectives included improvement in other anthropometric z‐scores, formula tolerance, and safety. RESULTS: Twenty‐six patients with poor growth due to congenital heart disease (n = 15), other organic causes (n = 9), and nonorganic causes (n = 2) completed the study per protocol. Mean daily energy intake was 123 ± 32 kilocalories per kilogram of body weight, with >90% of energy coming from EPEF. Weight gain velocity exceeded the median for 83% (20 of 24) and 67% (16 of 24) of infants at ≥1 time point and for the overall study period, respectively. Mean ± SD WAZ improved from −2.92 ± 1.04 at baseline to −2.01 ± 1.12 at 16 weeks (P = 0.0001). Z‐scores for weight‐for‐length and head circumference (P = 0.0001) and for length‐for‐age (P = 0.003) improved significantly at 16 weeks. Compared with baseline, stool consistency was different at 2, 4, and 16 weeks (P < 0.05). There were no significant differences in vomiting, fussiness, or daily number of stools while there was a decrease or no change in spit‐up, flatulence, crying, or gassiness. CONCLUSION: EPEF is safe, well tolerated, and improves weight gain in infants with poor growth.