Oropharyngeal Administration of Colostrum
Condition: Health Behavior
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Oropharyngeal administration of own mother's colostrum; Oropharyngeal administration of sterile water (placebo); Oropharyngeal administration of donor human milk
Intervention type(s): Biological; Other; Biological
Other intervention name(s): OMC Group; Placebo Group; DHM Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: colostrum