Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

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.
Infants currently participating in another trial
...
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.
Infants currently participating in another trial
Infant undergoing antibiotic therapy.
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

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

Exclusion Criteria

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.
Infants currently participating in another trial
...
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.
Infants currently participating in another trial
Infant undergoing antibiotic therapy.
Re-hospitalization for more than 2 days in the first 14 days of life.

Locations

Caen, Cedex 9, 14033
Tours, Cedex 9, 37044
Bordeaux, 33076
Palermo, 90127
...
Caen, Cedex 9, 14033
Tours, Cedex 9, 37044
Bordeaux, 33076
Palermo, 90127

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