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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02650167
Acronym
COLOSTRUM
Enrollment
140
Registered
2016-01-08
Start date
2016-04-27
Completion date
2020-09-24
Last updated
2020-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Premature

Brief 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.

Interventions

BIOLOGICALColostrum feeding
BIOLOGICALformula for preterm infants

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measuring caloric intake (number of days required for the calorie intake)2 daysnumber of days required for the calorie intake to 130 kcal / kg / day can be delivered exclusively enterally

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026