TOPLINE

Hydrolyzed rice formula (HRF) was used in routine pediatric practice as an additional nutritional option for infants with cow’s milk protein allergy (CMPA). Overall improvement with HRF was comparable to that with an extensively hydrolyzed formula (eHF).

METHODOLOGY

• Researchers conducted a real-world observational study to assess recommendations for and use of HRF and eHF in infants (median age at diagnosis, 2 months) with CMPA as well as short-term response to these formulas.
• They analyzed 1505 infant-level records from 269 pediatricians in primary care and hospital pediatric units across public and private healthcare settings in Spain.
• Of these, 1094 records from infants (46.7% girls) were in the prospective recommendation cohort, wherein pediatricians recorded formula recommendations for CMPA management, and 411 records from infants (39.2% girls) were in the retrospective treated cohort, wherein infants had already received one of the formulas and were followed up from day 0 to day 7.
• Outcomes included CMPA-related symptoms measured using the Cow’s Milk-related Symptom Score (CoMiSS) at baseline and day 7, percentage reduction in CoMiSS, time to observed clinical improvement, global clinical evolution, and product satisfaction.

TAKEAWAY

• In the prospective cohort, HRF was recommended in 19.6% of records. Older infant age was associated with higher odds of an HRF recommendation (odds ratio, 1.034 per month; P = .036), whereas immunoglobulin E (IgE)-mediated CMPA was associated with lower odds than non-IgE-mediated CMPA (odds ratio, 0.673; P = .043).
• Both formula groups showed marked symptom improvement from day 0 to day 7, with the absolute reduction in CoMiSS not being significantly different between the two formulas.
• The proportion of infants achieving reduction in CoMiSS and a CoMiSS < 6 at day 7 was significantly higher in the eHF group. The median time to observed clinical improvement was shorter with eHF (5 vs 7 days; P = .015).
• The global clinical evolution and product satisfaction scores were high and did not differ significantly between the formulas.

IN PRACTICE

“The findings support the feasibility and apparent short-term clinical usefulness of HRF in routine practice but should not be interpreted as evidence of equivalence or noninferiority to eHF,” the authors wrote.

SOURCE

Rafael Martín-Masot, MD, PhD, with the Hospital Regional Universitario de Málaga in Málaga, Spain, was the corresponding author of the study, which was published online on July 2 in Nutrients.

LIMITATIONS

This was an observational real-world study without random formula allocation; therefore, confounding by indication was a major limitation. Pediatricians may have chosen HRF or eHF based on clinical phenotype, perceived risk for allergy, prior formula refusal, palatability, family preference, or other unmeasured factors.

DISCLOSURES

Laboratorios Ordesa S.L. funded the ETAPA project and supported project logistics and data management. This study was an observational analysis from the ETAPA project. One author reported being an employee of the funding agency and contributed to the project. The remaining authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.