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Oropharyngeal Administration of Colostrum

NCT02912585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2016-09-23

No results posted yet for this study

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.

Conditions

  • Health Behavior

Interventions

BIOLOGICAL

Oropharyngeal administration of own mother's colostrum

OTHER

Oropharyngeal administration of sterile water (placebo)

BIOLOGICAL

Oropharyngeal administration of donor human milk

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do estado de Minas Gerais

    collaborator OTHER

  • Federal University of Uberlandia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
72 Hours
Max Age
5 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-07-31
Completion
2016-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02912585 on ClinicalTrials.gov