drugset / Trial / NCT02912585

Oropharyngeal Administration of Colostrum

NCT02912585 ↗

RandomizedParallel-groupTriple-blindPrevention

Summary

Infections are the main causes of morbidity and mortality in very low birth weight infants. Use of mother's own breast milk in feeding these babies is associated with a decreased risk of acquiring nosocomial infection. This protective effect is assigned to a plurality of immune components in human milk. However, clinical instability of the preterm newborn in the first days of life results in delayed initiation of enteral nutrition. Thus, alternative methods for colostrum administration have been investigated, such as oropharyngeal administration with evidence that would be safe and feasible to perform in children admitted to the NICU in the first hours of life. Objective: To evaluate the immune stimulatory effect of oropharyngeal administration of colostrum in the incidence of sepsis in very low birth weight preterm infants.

Timeline

Start
2013-07
Primary completion
2016-07
Completion
2016-07

Outcome

Missed primary endpoint

paper We found no statistically significant differences between colostrum and placebo groups in the incidence of late-onset clinical sepsis PMID 30964820 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator donor human milk Unknown — Other
Subject maternal colostrum Unknown 0.2 ml Other

Indications

No indication recorded.