Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
186 participants
INTERVENTIONAL
2009-09-30
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Breastfeeding (Reference)
No interventions assigned to this group
Basic starter formula: BSF
BSF
feeding amount according to individual baby need
BSF + Lactoferrin + Probiotics + OS
BSF + Lactoferrin + Probiotics + OS
feeding amount according to individual baby need
BSF + Lactoferrin + Probiotics
BSF + Lactoferrin + Probiotics
feeding amount according to individual baby need
Interventions
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BSF
feeding amount according to individual baby need
BSF + Lactoferrin + Probiotics
feeding amount according to individual baby need
BSF + Lactoferrin + Probiotics + OS
feeding amount according to individual baby need
Eligibility Criteria
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Inclusion Criteria
* Full term infant (≥ 37 weeks gestation; \< 42 weeks gestation)
* Birth weight from 2500g to 4500g
* For the formula-fed groups: babies whose mothers elected not to breastfeed at all
* For the breastfed group: babies whose mothers elected to exclusively breastfeed for at least 2 months
* Newborn whose parents / caregivers can be expected to comply with the protocol
* Study explained and written information given
* Informed consent signed
Exclusion Criteria
* Caesarian section
* Multiple birth
* Congenital illness or malformation that may affect normal growth
* Significant pre-natal and/or post-natal disease
* Newborn participating in another clinical trial
1 Day
3 Days
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Charles Pr Picaud
Role: PRINCIPAL_INVESTIGATOR
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
Locations
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Department of Pediatrics
Vienna, , Austria
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
Lyon, , France
Maternité Régionale, Service de Néonatologie
Nancy, , France
Service de Néonatologie
Nantes, , France
Hôpital Charles Nicolle, Département de Pédiatrie
Rouen, , France
Alexandra Regional General Hospital, Department of Neonatology
Palaió Fáliro, Athens, Greece
Countries
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Other Identifiers
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07.22.INF
Identifier Type: -
Identifier Source: org_study_id
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