Effects of Specific Lipid Fractions-enriched Infant Formulae
Multicenter, Randomized, Double-blind, Parallel-group, Reference-controlled, Safety Pilot Study to Evaluate the Effects of Specific Lipid Fractions-enriched Infant Formulae in Infants Aged 0-4 Months
1 other identifier
interventional
199
2 countries
4
Brief Summary
This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
4 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
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 9, 2014
CompletedFirst Posted
Study publicly available on registry
April 11, 2014
CompletedApril 11, 2014
April 1, 2014
1.1 years
April 9, 2014
April 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Mean weight gain (g/day)
Enrollment to age 4 months
Study Arms (3)
Standard infant formula
PLACEBO COMPARATORStandard infant formula fed ad libitum
Standard infant formula with PL1
EXPERIMENTALStandard infant formula enriched with PL1 lipid fraction fed ad libitum
Standard infant formula with PL2
EXPERIMENTALStandard infant formula enriched with PL2 lipid fraction fed ad libitum
Interventions
Eligibility Criteria
You may qualify if:
- Healthy newborn infant
- Infant is ≤14 days old on day of enrollment
- Gestational age ≥37 weeks (full term infants)
- Birth weight ≥2500 g and ≤4500 g
- Singleton birth
- Having obtained his/her parents'/legal representative's informed consent
You may not qualify if:
- Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
- Infant undergoing antibiotic therapy.
- Re-hospitalization for more than 2 days in the first 14 days of life.
- Parents not expected to comply with the protocol during the period of study participation.
- Infants currently participating in another trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU de Caen
Caen, Cedex 9, 14033, France
Hôpital Bretonneau - UPM
Tours, Cedex 9, 37044, France
Groupe Hospitalier Pellegrin
Bordeaux, 33076, France
Istituto di Ostetricia e Ginecologia Neonatalogia
Palermo, 90127, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Claude Billeaud, MD
Hôpital des enfants, CHU Pellegrin, Bordeaux, France
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
April 9, 2014
First Posted
April 11, 2014
Study Start
November 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 11, 2014
Record last verified: 2014-04