This study compared a commonly used nutritional intervention for failure to thrive infants (Similac(r) with Iron Concentrate fed at 24 kcal/oz) with a more calorically dense formula (PediaSure(r) - 30 kcal/oz). A double-blind randomized trial was conducted in a sample of children with failure to thrive(FTT) to assess effects on anthropometrics, dietary intake, biochemical measures, formula tolerance, and parent satisfaction. All children were evaluated and managed in a multidisciplinary clinic for FTT. Explicit anthropometric criteria were used for inclusion; infants with medical disease that prohibited use of study formulae were excluded. One hundred three infants were randomized and eighty were available at the final data collection (44/55 of 30 kcal/oz group, 36/48 of 24 kcal/oz group). There was no difference between treatment groups in the number of children or reason for failing to complete the four-month study. All clinicians (except the study nutritionist) and the parents were unaware of formula assignment. Anthropometric data and 24-hour diet recall were collected at baseline and at one, two, and four-month follow-up (FU). Biochemical studies were collected at baseline and at two month FU. Parent satisfaction and formula tolerance questionnaires were collected at one and four month FU. Study groups did not differ in birth weight (m=2629 gms), age of enrollment (m=12.8 mos), gender, ethnicity, prematurity, maternal education, or income. The 30 kcal/oz group had more children born SGA, and all anthropometric analyses were adjusted for this variable. The change in Z scores weight for age and weight for length for individuals from baseline to four months improved significantly for both groups (p≤.01) and did not differ between formula groups. The 30 kcal/oz group reported significantly higher caloric intake at one-month follow-up(p<.05), but not at two or four months. All biochemical data were within the normal reference range for population. The BUN and Hg at two months follow-up were significantly (p<.008) greater than baseline for the 30 kcal/oz group only. The 30 kcal/oz formula group was rated significantly better (p<.05) on both the parent satisfaction and formula tolerance questionnaires at one month only. In this short-term blinded randomized trial both formula groups showed improvement in anthropometric status over four months. The 30 kcal/oz formulation was better accepted and resulted in reported caloric intake and biochemical changes at least as beneficial as the standard formula treatment group.

This research was funded by Ross Products Division of Abbott Laboratories.