A randomized, controlled, double-blind parallel group trial to study the effects of an infant formula containing partially hydrolysed proteins on growth and tolerance in healthy term infants
- Conditions
- growth, weight gain, anthropometry, gastrointestinal comfort, safety, suitability, hydrolysate, intact protein, infant formula
- Registration Number
- NL-OMON27338
- Lead Sponsor
- FrieslandCampina
- Brief Summary
N/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 276
• Full-term infants (born at gestational age =37 weeks).
• Healthy birthweight (according to WHO Child Growth Standards): between 2500 and 4200 g, retrieved from medical records
• Boys and girls
• Apparently healthy at birth and screening
• Weight-for-age Z-score (WAZ), weight-for-length (WHZ), and length-for-age (LAZ) Z-scores at screening within the normal range according to WHO Child Growth Standards (i.e. -2 = WAZ,WHZ,LAZ = 2)
• Age at enrolment: =28 days of age
• Exclusively formula fed for at least 5 days prior to inclusion
• Exclusively formula fed during the entire intervention period
• Parents agreeing to initiate complementary feeding after finalization of the study
• Being available for follow up until the age of approximately 3.5 months
• Written informed consent from parent(s) and/or legal guardian(s) aged =18 years
• Gestational age <37 weeks
• Birth weight <2500 g or >4200 g
• Age at enrolment: >28 days
• Severe acquired or congenital diseases, mental or physical disorders, including cow’s milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect growth (i.e. GI disorders)
• Illness at screening/inclusion
• Incapability of parents to comply with the study protocol
• Illiterate parents (i.e. not able to read and write in local language)
• Participation in another clinical trial
• Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation
• infants fed a special diet other than standard, non-hydrolysed, cow’s or goat’s milk based infant formula
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Growth, measured as weight gain in g/day
- Secondary Outcome Measures
Name Time Method Anthropometry, including <br><br>-Weight (kg)<br><br>-Recumbent length (cm and cm/day)<br><br>-Head circumference (cm and cm/day)<br><br>-BMI<br><br>-Z-scores for all the above