Recruiting NCT05868408
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Control Formula, Experimental Formula 1, Experimental Formula 2.
- Who it may be relevant to
- Registry conditions: Infant Nutritional Physiological Phenomena, Infant Formula, Infant Health, Infant Development. Basic parameters: 0 Days — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Philippines, Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial
Overview
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
Interventions
- Other Control Formula
Infant formula made with intact protein - minimum 1.8g protein/100kcal - Other Experimental Formula 1
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal - Other Experimental Formula 2
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Primary outcome measures
- Difference in growth in first 4 months of life between control and experimental groups [Time frame: From enrollment to age 4 months]
- Equivalence in growth in first 4 months of life in experimental groups [Time frame: From enrollment to age 4 months]
Secondary outcome measures (12)
- Gastrointestinal (GI) tolerance [Time frame: Enrollment and age 4, 6, and 12 months]
- Stooling pattern [Time frame: Age 2 and 4 months]
- Atopic dermatitis severity [Time frame: Enrollment and age 4, 6, and 12 months]
- Allergy-related symptoms [Time frame: Enrollment and age 4, 6, and 12 months]
- Dietary intake [Time frame: Age 6 months]
- Weight [Time frame: Enrollment and age 1, 2, 3, 4, and 6 months]
- Length [Time frame: Enrollment and age 1, 2, 3, 4, and 6 months]
- Head circumference [Time frame: Enrollment and age 1, 2, 3, 4, and 6 months]
- Weight-for-age z-score [Time frame: Enrollment and age 1, 2, 3, 4, and 6 months]
- Weight-for-length z-score [Time frame: Enrollment and age 1, 2, 3, 4, and 6 months]
- Length-for-age z-score [Time frame: Enrollment and age 1, 2, 3, 4, and 6 months]
- Head circumference-for-age z-score [Time frame: Enrollment and age 1, 2, 3, 4, and 6 months]
Eligibility criteria
Inclusion criteria
- Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\]), if applicable)
- Infant gestational age ≥37 completed weeks
- Infant birth weight of ≥2.5 kg and ≤4.5 kg
- Singleton birth
- For Saudi: Infant postnatal age ≤28 days (date of birth = day 0); For Philippines: Infant postnatal age ≥ 14 days and ≤ 28 days (date of birth = day 0).
- Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
- 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
- Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
- Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
- Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
- Infants with special dietary needs other than standard infant formula
- Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet
- Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
- Currently participating or having participated in another interventional clinical trial prior to enrollment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
Saudi Arabia · 3 centers
- National Guard Hospital — Jeddah
- King Faisal Specialist Hospital and Research Center — Riyadh
- National Guard Hospital — Riyadh
Philippines · 2 centers
- Biomedical Research Institute — Cavite City
- Biomedical Research Institute — Las Piñas
Identifiers
NCT: NCT05868408 · 21.10.INF