About this trial
Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula.
Eligibility criteria
Qualifiers
Full-term infant(gestational age ≥37 weeks and ≤42 weeks).
Birth weight ≥2500 g and ≤4500 g.
Parent(s)/LAR deemed able to provide written informed consent for participation of their infant in the study (in the opinion of the investigator).
Participant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks) at time of enrollment.
Disqualifiers
Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
Congenital illness or malformation that may affect growth, or significant pre-natal and/or serious post-natal disease other than CMPA before randomization (per investigator's medical decision).
Demonstrated chronic malabsorption not due to CMPA.
History of severe anaphylaxis to CMP.
Trial design
Treatments tested in this trial
- New generation eHF
- Commercial eHF