NCT02911454
Completed
Not Applicable
Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations
Nutricia Research12 sites in 3 countries252 target enrollmentStarted: July 2016Last updated:
ConditionsHealthy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nutricia Research
- Enrollment
- 252
- Locations
- 12
- Primary Endpoint
- Stool consistency measured by Amsterdam Stool Scale.
Overview
Brief Summary
A prospective, multi-country, open label study to describe the stool characteristics and behaviour as well as the parents' experience in infants receiving a recently launched infant formula in a real life situation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 1 Hour to 6 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Healthy term infants, gestational age up to and including 37 weeks and 42 weeks and below. Healthy is defined as "no supervision or medical treatment by a medical specialist. Further more to be determined by HCP.
- •Birth weight between 2.5 - 4.5 KG (within normal range for gestational age and sex)
- •Infants up to 6 weeks of postnatal age (Including day 42)
- •Receiving exclusively or at least 1 complete infant formula feeding per day at study inclusion (retrospectively exclusively or partly formula fed)
- •Willingness to change from their regular infant formula to study product
- •Parents' or legal guardians' aged up to and including 18 years, written, informed consent.
Exclusion Criteria
- •Infants with a congenital condition and / or previous or current illness and (or) medication that could interfere with the study
- •Infants with established or suspected cows milk allergy, lactose intolerance, galactosaemia or infants on a prescribed fibre free (e.g. prebiotic oligosaccharides) diet
- •Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study
- •Investigator's uncertainty about the willingness of the parents / legal guardians to comply with the protocol requirements.
Outcomes
Primary Outcomes
Stool consistency measured by Amsterdam Stool Scale.
Time Frame: 15 months
Will be reported in diaries completed by the parents.
Crying time
Time Frame: 15 months
Will be reported in diaries completed by the parents.
Stool frequency
Time Frame: 15 months
Will be reported in diaries completed by the parents.
Secondary Outcomes
- Impact on family life(15 months)
- Eating behaviour(15 months)
- Parental experience of child behaviour(15 months)
Investigators
Study Sites (12)
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