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NCT02650167 Clinical Trial

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

Infant, Premature Clinical Trial

— COLOSTRUM  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02650167
Other study ID # 15-AOI-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 27, 2016
Est. completion date September 24, 2020

Study information
Verified date September 2020
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date September 24, 2020
Est. primary completion date May 5, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Colostrum feeding

• formula for preterm infants

Locations
Country Name City State
France CHU de Nice Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measuring caloric intake (number of days required for the calorie intake) number of days required for the calorie intake to 130 kcal / kg / day can be delivered exclusively enterally 2 days
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