Effects of Specific Lipid Fractions-enriched Infant Formulae
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Having obtained his/her parents'/legal representative's informed consent
- Singleton birth
- Healthy newborn infant
- ...
- Having obtained his/her parents'/legal representative's informed consent
- Singleton birth
- Healthy newborn infant
- Birth weight ≥2500 g and ≤4500 g
- Infant is ≤14 days old on day of enrollment
- Gestational age ≥37 weeks (full term infants)
Exclusion Criteria
- Parents not expected to comply with the protocol during the period of study participation.
- Infant undergoing antibiotic therapy.
- Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
- ...
- Parents not expected to comply with the protocol during the period of study participation.
- Infant undergoing antibiotic therapy.
- Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
- Infants currently participating in another trial
- Re-hospitalization for more than 2 days in the first 14 days of life.
Summary
- Conditions
- Infant Growth
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Participation Requirements
- Age
- Younger than 14 years
- Gender
- Both males and females
Inclusion Criteria
- Having obtained his/her parents'/legal representative's informed consent
- Singleton birth
- Healthy newborn infant
- ...
- Having obtained his/her parents'/legal representative's informed consent
- Singleton birth
- Healthy newborn infant
- Birth weight ≥2500 g and ≤4500 g
- Infant is ≤14 days old on day of enrollment
- Gestational age ≥37 weeks (full term infants)
Exclusion Criteria
- Parents not expected to comply with the protocol during the period of study participation.
- Infant undergoing antibiotic therapy.
- Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
- ...
- Parents not expected to comply with the protocol during the period of study participation.
- Infant undergoing antibiotic therapy.
- Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
- Infants currently participating in another trial
- Re-hospitalization for more than 2 days in the first 14 days of life.
Tracking Information
- NCT #
- NCT02111837
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Claude Billeaud, MD Hôpital des enfants, CHU Pellegrin, Bordeaux, France
- Claude Billeaud, MD Hôpital des enfants, CHU Pellegrin, Bordeaux, France
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