Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

Infant undergoing antibiotic therapy.
Parents not expected to comply with the protocol during the period of study participation.
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.
Parents not expected to comply with the protocol during the period of study participation.
Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
Re-hospitalization for more than 2 days in the first 14 days of life.
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

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

Exclusion Criteria

Infant undergoing antibiotic therapy.
Parents not expected to comply with the protocol during the period of study participation.
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.
Parents not expected to comply with the protocol during the period of study participation.
Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
Re-hospitalization for more than 2 days in the first 14 days of life.
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