A New Adaptive Feeding Plan for Newborns
1 other identifier
interventional
186
3 countries
6
Brief Summary
The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 10, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedJune 5, 2013
June 1, 2013
1.3 years
September 10, 2009
June 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
gut maturation : Specific proteins in stools
3rd day, at 1 week, 2 weeks and 1 month of age
Secondary Outcomes (1)
Growth and gut microbiota
At 1 month and 2 months
Study Arms (4)
Breastfeeding (Reference)
NO INTERVENTIONBasic starter formula: BSF
ACTIVE COMPARATORBSF + Lactoferrin + Probiotics + OS
EXPERIMENTALBSF + Lactoferrin + Probiotics
EXPERIMENTALInterventions
feeding amount according to individual baby need
feeding amount according to individual baby need
Eligibility Criteria
You may qualify if:
- Healthy newborn infant
- 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
You may not qualify if:
- Mother who had antibiotics in the 7 days preceding delivery
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Department of Pediatrics
Vienna, 1090, Austria
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
Lyon, 69317, France
Maternité Régionale, Service de Néonatologie
Nancy, 54042, France
Service de Néonatologie
Nantes, 44093, France
Hôpital Charles Nicolle, Département de Pédiatrie
Rouen, 76031, France
Alexandra Regional General Hospital, Department of Neonatology
Palaió Fáliro, Athens, 17562, Greece
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Charles Pr Picaud
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2009
First Posted
September 25, 2009
Study Start
September 1, 2009
Primary Completion
January 1, 2011
Study Completion
February 1, 2011
Last Updated
June 5, 2013
Record last verified: 2013-06