Growth And Safety Outcomes In Infants With Cow´s Milk Protein Allergy (CMPA) Fed A Novel Extensively Hydrolyzed Formula (eHF)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age29-22
SponsorSociété des Produits Nestlé (SPN)

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

Treatment groups

410 Participants
are divided into 2 treatment groups

Locations

This trial has no locations