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

Not Applicable

Completed

• Conditions: Infant, Premature
• Interventions: Biological: formula for preterm infants; Biological: Colostrum feeding

• Registration Number: NCT02650167
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Study Start: 2016-04-27
• Primary Completion: 2018-05-05
• Status Verified: 2020-09
• Study Completion: 2020-09-24
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Witness	formula for preterm infants	-
Colostrum	Colostrum feeding	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France