Status:
COMPLETED
Effect of Starter Formula on Infection Prevention
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Gastro-intestinal Infections
Infections With Fever
Eligibility:
All Genders
Up to 12 years
Phase:
NA
Brief Summary
The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.
Eligibility Criteria
Inclusion
- Healthy newborn infant
- Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
- Age of infant is ≤ 13 days at the time of enrollment
- Birth weight ≥ 2500g and ≤ 4500g
- For the FF groups: The infant's mother has elected not to breastfeed
- For the BF group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
- Having obtained his/her legal representative's informed consent
Exclusion
- Congenital illness or malformation that may affect normal growth (especially immunodeficiencies)
- Significant pre-natal and/or post-natal diseases
- Perinatal antibiotic or infants on antibiotics at the time of inclusion
- Infants whose mother has had an acute infection during the last month of pregnancy
- Re-hospitalisation for more than 2 days in the first 14 days of life (exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study)
- Receiving infant formula containing probiotics and/or prebiotics at the time of enrollment
- Newborn whose parents / caregivers cannot be expected to comply with treatment
- Newborn currently participating in another interventional clinical trial
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
477 Patients enrolled
Trial Details
Trial ID
NCT01880970
Start Date
October 1 2008
End Date
October 1 2013
Last Update
October 21 2015
Active Locations (7)
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1
Hôpital de la Croix Rousse, Service de réanimation néonatale
Lyon, France, 69317
2
Hôpital Arnaud de Villeneuve, Service de pédiatrie 2
Montpellier, France, 34295
3
Maternité régionale de Nancy, Service de Néonatologie
Nancy, France, 54042
4
Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin
Berlin, Germany, 13353