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OpenTrials
Completed

NCT Number: NCT02650167

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

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.

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colostrum feeding

Biological

formula for preterm infants

Biological

Primary outcomes

  1. Measuring caloric intake (number of days required for the calorie intake)

    Time frame: 2 days

    number of days required for the calorie intake to 130 kcal / kg / day can be delivered exclusively enterally

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: COLOSTRUM

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jan 8, 2016
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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