NCT04066413
Terminated
Not Applicable
Growth and Tolerance Trial in Healthy Infants on Infant Formula Supplemented With a Human Milk Oligosaccharide
FrieslandCampina1 site in 1 country265 target enrollmentSeptember 23, 2019
ConditionsHealthy Growth
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Growth
- Sponsor
- FrieslandCampina
- Enrollment
- 265
- Locations
- 1
- Primary Endpoint
- Growth
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Gestational age ≥ 37 weeks
- •Birth weight ≥ 2500 grams
- •No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)
- •Boys and girls
- •Recruited \< 1 month/age
- •Being available for follow up until the age of 4 months
- •Exclusive formula feeding or exclusive breast feeding at time of recruitment
Exclusion Criteria
- •Gestational age \<37 weeks
- •Birth weight \<2500 grams
- •Severe acquired or congenital diseases, mental or physical disorders
- •Illness at screening/ inclusion
- •Incapability of parents/caregivers to comply with the study protocol
- •Received antibiotics within the first month of life
- •Not tolerating standard cow's milk based infant formula
- •Participation in another clinical trial
- •Maternal illicit drug use during pregnancy or post-partum period
- •Parent/caregiver does not have a cell phone to use for filling out questionnaires
Outcomes
Primary Outcomes
Growth
Time Frame: From enrollment until end of the 3 month-study
Infant growth measured as body weight gain per day
Secondary Outcomes
- Weight(Monthly, from enrollment until end of the 3 month-study)
- Head circumference(Monthly, from enrollment until end of the 3 month-study)
- Recumbent length(Monthly, from enrollment until end of the 3 month-study)
- Anthropometry z-scores(Monthly, from enrollment until end of the 3 month-study)
- Formula tolerance(Monthly, from enrollment until end of the 3 month-study)
- Gastro-intestinal comfort(Monthly, from enrollment until end of the 3 month-study)
Study Sites (1)
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