Recruitment

Recruitment Status
Completed

Inclusion Criteria

Gestational age ≥37 weeks (full term infants)
Birth weight ≥2500 g and ≤4500 g
Singleton birth
...
Gestational age ≥37 weeks (full term infants)
Birth weight ≥2500 g and ≤4500 g
Singleton birth
Healthy newborn infant
Infant is ≤14 days old on day of enrollment
Having obtained his/her parents'/legal representative's informed consent

Exclusion Criteria

Parents not expected to comply with the protocol during the period of study participation.
Re-hospitalization for more than 2 days in the first 14 days of life.
Infant undergoing antibiotic therapy.
...
Parents not expected to comply with the protocol during the period of study participation.
Re-hospitalization for more than 2 days in the first 14 days of life.
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

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

Gestational age ≥37 weeks (full term infants)
Birth weight ≥2500 g and ≤4500 g
Singleton birth
...
Gestational age ≥37 weeks (full term infants)
Birth weight ≥2500 g and ≤4500 g
Singleton birth
Healthy newborn infant
Infant is ≤14 days old on day of enrollment
Having obtained his/her parents'/legal representative's informed consent

Exclusion Criteria

Parents not expected to comply with the protocol during the period of study participation.
Re-hospitalization for more than 2 days in the first 14 days of life.
Infant undergoing antibiotic therapy.
...
Parents not expected to comply with the protocol during the period of study participation.
Re-hospitalization for more than 2 days in the first 14 days of life.
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

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