Trials / Completed
CompletedNCT02650167
Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Nice · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Colostrum feeding | |
| BIOLOGICAL | formula for preterm infants |
Timeline
- Start date
- 2016-04-27
- Primary completion
- 2018-05-05
- Completion
- 2020-09-24
- First posted
- 2016-01-08
- Last updated
- 2020-09-30
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02650167. Inclusion in this directory is not an endorsement.