Recruitment

Recruitment Status
Completed

Inclusion Criterias

Healthy newborn infant
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
Gestational age ≥37 weeks (full term infants)
Having obtained his/her parents'/legal representative's informed consent
Birth weight ≥2500 g and ≤4500 g

Exclusion Criterias

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

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 Criterias

Healthy newborn infant
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
Gestational age ≥37 weeks (full term infants)
Having obtained his/her parents'/legal representative's informed consent
Birth weight ≥2500 g and ≤4500 g

Exclusion Criterias

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

Locations

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

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