Tolerance and growth outcomes in children diagnosed with cow’s milk protein allergy and prescribed an extensively hydrolyzed casein formula (Damira 2000©) in Spain: The DELISA study

OBJECTIVE: This study assessed the tolerance of a commercial, extensively hydrolyzed casein formula (eHCF), in a cohort of children with cow's milk protein allergy (CMPA) as a primary outcome, as well as its effect on growth outcomes. METHODS: Observational retrospective study of CMPA patients taking eHCF for at least 4 months. Patients were followed for three visits. RESULTS: A total of 61 evaluable pediatric patients with CMPA were included in the study. The patients had a follow-up period of 8.4 months, with a mean age of 3.1 ± 2.5 months at the first hospital visit, and 11.5 ± 5.3 months at the second follow-up visit. At the first hospital visit, the weight, height, and body mass index (BMI) were recorded as 5.6 ± 1.4 kg, 59.3 ± 6.1 cm, and 15.6 ± 1.7, respectively, increasing to 9.2 ± 1.5 kg, 73.9 ± 6.5 cm, and 16.9 ± 1.4 at the second follow-up visit. The mean Z-scores for weight-for-age (WAZ), height-for-age (HAZ), BMI for age (BAZ), and weight-for-height (WHZ) were -0.36 ± 0.95, -0.26 ± 1.00, -0.29 ± 1.05, and -0.22 ± 1.1, respectively, at the first hospital visit, and 0.09 ± 0.79, 0.05 ± 1.03, 0.10 ± 0.87, and 0.13 ± 0.85 at the second follow-up visit. The eHCF was well tolerated by 100% of patients with no immediate allergic or intestinal reactions recorded during the follow-up visits. CONCLUSIONS: The participating physicians rated the tolerance of the eHCF as good in 100% of the patients (95% CI: 94.1-100). Over a follow-up period of 8.4 months, pediatric patients with CMPA consuming the eHCF showed anthropometric Z-scores WAZ, HAZ, BAZ, and WHZ between -1 and 1, within a range close to the mean of a standard normal distribution.