Oropharyngeal Administration of Colostrum

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

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Biological: Oropharyngeal administration of own mother's colostrum; Other: Oropharyngeal administration of sterile water (placebo); Biological: Oropharyngeal administration of donor human milk

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.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 5 days (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Own mother's colostrum; Oropharyngeal administration of own mother's colostrum.	Biological: Oropharyngeal administration of own mother's colostrum; Other Names: OMC Group
PLACEBO_COMPARATOR: Placebo; Oropharyngeal administration of sterile water.	Other: Oropharyngeal administration of sterile water (placebo); Other Names: Placebo Group
ACTIVE_COMPARATOR: Donor human milk; Oropharyngeal administration of donor human milk.	Biological: Oropharyngeal administration of donor human milk; Other Names: DHM Group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia
• Collaborators: Fundação de Amparo à Pesquisa do estado de Minas Gerais

Publications and helpful links

General Publications

• Ferreira DMLM, Oliveira AMM, de Leves DV, de Bem EB, Fatureto GG, Navarro NF, Afonso NG, Santiago FM, Mineo JR, Sopelete MC, Martinez FE, Bernardino Neto M, Abdallah VOS. Randomized Controlled Trial of Oropharyngeal Colostrum Administration in Very-low-birth-weight Preterm Infants. J Pediatr Gastroenterol Nutr. 2019 Jul;69(1):126-130. doi: 10.1097/MPG.0000000000002356.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (ESTIMATE): September 23, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: colostrum
• Other Study ID Numbers: CEP 333.886

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO