Oropharyngeal Administration of Colostrum

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Health Behavior

Intervention / Treatment
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* Biological: Oropharyngeal administration of own mother's colostrum
* Other: Oropharyngeal administration of sterile water (placebo)
* Biological: Oropharyngeal administration of donor human milk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 72 Hours
Maximum Age: 5 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Own mother's colostrum<br>Oropharyngeal administration of own mother's colostrum. | Biological: Oropharyngeal administration of own mother's colostrum<br> <br> * Other names: OMC Group;|
| Placebo Comparator: Placebo<br>Oropharyngeal administration of sterile water. | Other: Oropharyngeal administration of sterile water (placebo)<br> <br> * Other names: Placebo Group;|
| Active Comparator: Donor human milk<br>Oropharyngeal administration of donor human milk. | Biological: Oropharyngeal administration of donor human milk<br> <br> * Other names: DHM Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of late-onset sepsis | Number of participants with late-onset sepsis | 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 | an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colostrum