An interventional study of Oropharyngeal administration of own mother's colostrum and Oropharyngeal administration of sterile water (placebo) in Health Behavior, sponsored by Federal University of Uberlandia. Completed. Open to participants aged 72 Hours to 5 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-23.
Sponsored by Federal University of Uberlandia · Not applicable, Interventional, and Prevention
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.
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.
251 studies on the registry are indexed under Health Behavior; 98 are open to participants now.
This study's enrollment of 145 is above the median of 120 across 215 interventional studies indexed under Health Behavior.
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Exclusion Criteria:
Oropharyngeal administration of own mother's colostrum.
Biological: Oropharyngeal administration of own mother's colostrum
Oropharyngeal administration of sterile water.
Other: Oropharyngeal administration of sterile water (placebo)
Oropharyngeal administration of donor human milk.
Biological: Oropharyngeal administration of donor human milk
Also known as: OMC Group
Also known as: Placebo Group
Also known as: DHM Group
Incidence of late-onset sepsis
Number of participants with late-onset sepsis
Time frame: an average of 3 months
Measurement of immunologic factors in urine and blood samples using enzyme-linked immunoassay (ELISA).
ELISA Index of immunologic factors in urine and blood samples
Time frame: an average of 3 months
No study locations are listed for this record.
Plan to share: No
The record gives a start of Jul 2013, a primary completion of Jul 2016 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Federal University of Uberlandia