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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-27

Study Completion Date

2020-09-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Infant, Premature

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Colostrum

Group Type EXPERIMENTAL

Colostrum feeding

Intervention Type BIOLOGICAL

Witness

Group Type EXPERIMENTAL

formula for preterm infants

Intervention Type BIOLOGICAL

Interventions

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Colostrum feeding

Intervention Type BIOLOGICAL

formula for preterm infants

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No