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Completed

NCT Number: NCT02912585

Oropharyngeal Administration of Colostrum

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.

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Key information

Conditions

Health Behavior Behavior

Age range

72 hour–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Background: 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.

Methods: This was a prospective, randomized and blind study that included infants less than 34 weeks gestational age and birth weight less than 1,500 g, from 15 July 2013 to 15 July 2015.

The babies were divided initially into two groups for oropharyngeal administration or not of mother's own milk: Group 1 - underwent oropharyngeal administration of mother's own milk of and Group 2 - underwent oropharyngeal administration of sterile water, considered an inert substance. Newborns who were drawn to the Group 1 and it was not possible to obtain sufficient mother's own milk volume constituted a third group called Group 3 that receive oropharyngeal administration of donor breast milk. Oropharyngeal administration were initiated within the first 48-72 hours of life and maintained for 48 hours. Before the oropharyngeal administration, 24 hours after and 14 days after, samples of blood and urine were collected from the newborns to IgA and lactoferrin dosage.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Birth weight < 1500 g and gestational age < 34 weeks

Exclusion criteria

  • congenital anomalies
  • gastrointestinal disorders
  • maternal history of substance abuse or positive maternal HIV status.

Treatment and study plan

Oropharyngeal administration of own mother's colostrum

Biological

Other names: OMC Group

Oropharyngeal administration of sterile water (placebo)

Other

Other names: Placebo Group

Oropharyngeal administration of donor human milk

Biological

Other names: DHM Group

Primary outcomes

  1. Incidence of late-onset sepsis

    Time frame: an average of 3 months

    Number of participants with late-onset sepsis

  2. Measurement of immunologic factors in urine and blood samples using enzyme-linked immunoassay (ELISA).

    Time frame: an average of 3 months

    ELISA Index of immunologic factors in urine and blood samples

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Collaborators

  • Fundação de Amparo à Pesquisa do estado de Minas Gerais

Registry information

Official study title

Oropharyngeal Administration of Colostrum and Prevention of Infections in Very Low Birthweight Infants

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2016
Registry last updated
Sep 23, 2016

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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