Oropharyngeal Administration of Colostrum

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912585
• Other study ID #: CEP 333.886
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: September 22, 2016
• Start date: July 2013
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Fundação de Amparo a Pesquisa de Minas Gerais
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Health Behavior

Intervention

Biological:
• Oropharyngeal administration of own mother's colostrum

Other:
• Oropharyngeal administration of sterile water (placebo)

Biological:
• Oropharyngeal administration of donor human milk

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Uberlandia	Fundação de Amparo à Pesquisa do estado de Minas Gerais

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of late-onset sepsis	Number of participants with late-onset sepsis	an average of 3 months	Yes
Primary	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	Yes