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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
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant, Premature

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 6, 2016
Last Updated
September 28, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
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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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