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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
NA trial testing Colostrum feeding in Infant, Premature in 140 participants. Completed in 24 September 2020.
5 May 2018
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Nice |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 140 |
| Start date | 27 April 2016 |
| Primary completion | 5 May 2018 |
| Estimated completion | 24 September 2020 |
| Sites | 1 location across France |
Drugs / interventions tested
- Colostrum feeding — full drug profile →
- formula for preterm infants — full drug profile →
Conditions studied
- Infant, Premature — all drugs for Infant, Premature →
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):
-
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:
- PubMed search for NCT02650167
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT00009633 — Follow-up Visit of High Risk Infants · recruiting
Other Centre Hospitalier Universitaire de Nice trials
Trials by the same sponsor.
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- NCT07492251 — Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Ran · Phase 2 · not yet recruiting
- NCT07511608 — Development of a New Technique for Quantifying Mitochondrial DNA in Single Muscle Fibers · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02650167 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nice
- Last refreshed: 30 September 2020
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