Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants

Launched by SOCIÉTÉ DES PRODUITS NESTLÉ (SPN) · May 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special type of infant formula called partially hydrolyzed, whey-based formula on the growth and digestive comfort of healthy babies. The goal is to see how well this formula helps infants gain weight and tolerate feeding, which can be important for their overall health and development.

To participate in this study, infants need to be at least 37 weeks old, weigh between 2.5 and 4.5 kilograms at birth, and be no more than 28 days old. The baby must be fully formula-fed and not breastfeeding. Parents or guardians will need to give their permission for their baby to join the study. Throughout the trial, participants will be monitored to ensure they are growing well and handling the formula comfortably. This research could provide valuable information for parents and healthcare providers about the best nutritional options for infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\]), if applicable)
• • 2. Infant gestational age ≥37 completed weeks
• • 3. Infant birth weight of ≥2.5 kg and ≤4.5 kg
• • 4. Singleton birth
• • 5. Infant postnatal age ≤28 days (date of birth = day 0)
• • 6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
• • 7. Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol
• Exclusion Criteria:
• • 1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
• • 2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
• • 3. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
• • 4. Infants with special dietary needs other than standard infant formula
• • 5. Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet
• • 6. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
• • 7. Currently participating or having participated in another interventional clinical trial prior to enrollment