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Oropharyngeal Administration of Colostrum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02912585
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Information provided by (Responsible Party):
Daniela Marques de Lima Mota Ferreira, Federal University of Uberlandia

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniela Marques de Lima Mota Ferreira, Principal Investigator / Professor of Pediatrics / Head of Neonatology Division, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT02912585    
Other Study ID Numbers: CEP 333.886
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Daniela Marques de Lima Mota Ferreira, Federal University of Uberlandia:
colostrum