The role of pre- and probiotics in infections in term infants (De role van pre- en probiotica in infecties in a terme geboren kinderen)
Completed
- Conditions
- Heathy term infants with intercurrent diseases: diarrhoea and respiratory infectionsNeonatal DiseasesOther conditions originating in the perinatal period
- Registration Number
- ISRCTN65140085
- Lead Sponsor
- Royal Friesland Foods B.V. (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 375
Inclusion Criteria
1. Healthy term infants with a post-menstrual age of 37 - 42 weeks, either sex
2. Birth weight between P10 and P90
3. Informed consent of both parents
Exclusion Criteria
1. Neonatal sepsis
2. Severe congenital malformations
3. Birth asphyxia (apgar less than six at 5 minutes, and/or umbilical cord pH less than 7.00 and/or necessity of reanimation)
4. Admission to a paediatric ward
5. No Dutch or English speaking parents
6. Antibiotics to the mother during labour
7. Antibiotics to the infant in the first week of life
8. History of allergy with parents or siblings
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method