ClinicalTrials.Veeva

Menu

Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea (COLOSTRUM)

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Infant, Premature

Treatments

Biological: Colostrum feeding
Biological: formula for preterm infants

Study type

Interventional

Funder types

Other

Identifiers

NCT02650167
15-AOI-02

Details and patient eligibility

About

Colostrum is the first milk secreted by the mother when the tight junctions of mammary epithelium open, allowing the cellular transport of a multitude of components and immunological protective derivatives of the maternal circulation to the milk, and especially immunoglobulins A type. Colostrum is not given to preterm neonates. The assumption behind this work is that the oro pharyngeal administration of colostrum early in preterm infants could help deliver an oral immunotherapy even before the installation of enteral nutrition, through interactions with lymphoid tissues of the oropharynx and the gastrointestinal tract. This practice would improve the digestive tolerance and the establishment of enteral feeding, the decrease in mucosal inflammatory phenomena, but also to provide any protection against subsequent infections. Finally, there could be an improvement in the secondary immune tolerance with a decrease in the occurrence of allergic phenomena.

Enrollment

140 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • New premature infant with a term weight ≤ 32 weeks amenorrhea at Nice University Hospital
  • Mother seronegative for HIV

Exclusion criteria

  • Neonates with congenital pathologies immediate prenatal or neonatal diagnosis will not be included.
  • Therapy of the mother incompatible with breastfeeding during pregnancy

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Colostrum
Experimental group
Treatment:
Biological: Colostrum feeding
Witness
Experimental group
Treatment:
Biological: formula for preterm infants

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems