Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea
COLOSTRUM
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2016
CompletedFirst Posted
Study publicly available on registry
January 8, 2016
CompletedStudy Start
First participant enrolled
April 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2020
CompletedSeptember 30, 2020
September 1, 2020
2 years
January 6, 2016
September 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Colostrum
EXPERIMENTALWitness
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- New premature infant with a term weight ≤ 32 weeks amenorrhea at Nice University Hospital
- Mother seronegative for HIV
You may not qualify if:
- Neonates with congenital pathologies immediate prenatal or neonatal diagnosis will not be included.
- Therapy of the mother incompatible with breastfeeding during pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice
Nice, 06003, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stéphanie DE SMET, Dr
Centre Hospitalier Universitaire de Nice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2016
First Posted
January 8, 2016
Study Start
April 27, 2016
Primary Completion
May 5, 2018
Study Completion
September 24, 2020
Last Updated
September 30, 2020
Record last verified: 2020-09