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NCT02650167: COLOSTRUM

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

Completed NA Last updated 30 September 2020
What this trial tests

NA trial testing Colostrum feeding in Infant, Premature in 140 participants. Completed in 24 September 2020.

Timeline
27 April 2016
Primary endpoint
5 May 2018
24 September 2020

Quick facts

Lead sponsorCentre Hospitalier Universitaire de Nice
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment140
Start date27 April 2016
Primary completion5 May 2018
Estimated completion24 September 2020
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

Eligibility, any sex, with Infant, Premature. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Oropharyngeal Colostrum for Preterm Infants: A Systematic Review and Meta-Analysis.
    Panchal H, Athalye-Jape G, Patole S. · · 2019 · cited 28× · PMID 31147686 · DOI 10.1093/advances/nmz033

Verify or expand the search:

Other recruiting trials for Infant, Premature

Currently open trials in the same condition.

Other Centre Hospitalier Universitaire de Nice trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02650167.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing