Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea (COLOSTRUM)
Primary Purpose
Infant, Premature
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Colostrum feeding
formula for preterm infants
Sponsored by

About this trial
This is an interventional prevention trial for Infant, Premature
Eligibility Criteria
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
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Colostrum
Witness
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02650167
First Posted
January 6, 2016
Last Updated
September 28, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02650167
Brief Title
Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea
Acronym
COLOSTRUM
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 27, 2016 (Actual)
Primary Completion Date
May 5, 2018 (Actual)
Study Completion Date
September 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colostrum
Arm Type
Experimental
Arm Title
Witness
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Colostrum feeding
Intervention Type
Biological
Intervention Name(s)
formula for preterm infants
Primary Outcome Measure Information:
Title
Measuring caloric intake (number of days required for the calorie intake)
Description
number of days required for the calorie intake to 130 kcal / kg / day can be delivered exclusively enterally
Time Frame
2 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie DE SMET, Dr
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06003
Country
France
12. IPD Sharing Statement
Learn more about this trial
Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea
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