Recruitment

Recruitment Status
Completed

Inclusion Criteria

Birth weight ≥2500 g and ≤4500 g
Having obtained his/her parents'/legal representative's informed consent
Infant is ≤14 days old on day of enrollment
...
Birth weight ≥2500 g and ≤4500 g
Having obtained his/her parents'/legal representative's informed consent
Infant is ≤14 days old on day of enrollment
Healthy newborn infant
Singleton birth
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

Birth weight ≥2500 g and ≤4500 g
Having obtained his/her parents'/legal representative's informed consent
Infant is ≤14 days old on day of enrollment
...
Birth weight ≥2500 g and ≤4500 g
Having obtained his/her parents'/legal representative's informed consent
Infant is ≤14 days old on day of enrollment
Healthy newborn infant
Singleton birth
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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