Oropharyngeal Administration of Colostrum
|ClinicalTrials.gov Identifier: NCT02912585|
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Health Behavior||Biological: Oropharyngeal administration of own mother's colostrum Other: Oropharyngeal administration of sterile water (placebo) Biological: Oropharyngeal administration of donor human milk||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||145 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Oropharyngeal Administration of Colostrum and Prevention of Infections in Very Low Birthweight Infants|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Own mother's colostrum
Oropharyngeal administration of own mother's colostrum.
Biological: Oropharyngeal administration of own mother's colostrum
Other Name: OMC Group
Placebo Comparator: Placebo
Oropharyngeal administration of sterile water.
Other: Oropharyngeal administration of sterile water (placebo)
Other Name: Placebo Group
Active Comparator: Donor human milk
Oropharyngeal administration of donor human milk.
Biological: Oropharyngeal administration of donor human milk
Other Name: DHM Group
- Incidence of late-onset sepsis [ Time Frame: an average of 3 months ]Number of participants with late-onset sepsis
- 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