Energy- and protein-enriched formula improves weight gain in infants with malnutrition due to cardiac and non-cardiac 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 were enrolled to receive EPEF for 16 weeks. PRIMARY OBJECTIVE improvement in weight as measured by change in weight-for-age z-score (WAZ) and weight gain velocity (g/day) ≥ median weight gain velocity for age based on WHO growth standards. Secondary objectives: improvements in other anthropometric z-scores, formula tolerance, and safety. RESULTS 26 subjects with poor growth due to congenital heart disease (15/26), other organic causes (9/26), and non-organic causes (2/26) completed the study per protocol. Mean calorie intake was 123 ± 32 kcals/kg body weight per day with >90% of calories coming from EPEF. Weight gain velocity exceeded the WHO median for 83% (20/24) and 67% (16/24) 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) were significantly improved at 16 weeks. There were no significant differences from baseline in vomiting, fussiness, or number of stools per day. Compared to baseline, stool consistency was different at 2,4, and 16 weeks (p < 0.05). 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. This article is protected by copyright. All rights reserved.