Clinical trial NCT01880970: Effect of Starter Formula on Infection Prevention
Official title: Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-intestinal Infections
Infections With Fever
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-06-19
Enrollment: 477
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Diarrhea and all infections with fever
timeFrame: over 6 months and 1 year
Secondary outcomes:
measure: Morbidity
timeFrame: over 6 months and 1 year
measure: Anthropometry
timeFrame: until 1 year
measure: Digestive tolerance
timeFrame: until 1 year
measure: Stool characteristics
timeFrame: at 3 and 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse, Service de réanimation néonatale
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve, Service de pédiatrie 2
city: Nancy
country: France
facility: Maternité régionale de Nancy, Service de Néonatologie
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin
city: Giessen
country: Germany
facility: Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin
city: Potsdam
country: Germany
facility: Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde
Study officials:
affiliation: Maternité régionale de Nancy
name: Jean Michel Hascoet, Prof.
role: PRINCIPAL_INVESTIGATOR
References: