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Oropharyngeal Administration of Colostrum

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02912585
Enrollment
145
Registered
2016-09-23
Start date
2013-07-31
Completion date
2016-07-31
Last updated
2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

Keywords

colostrum

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.

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.

Interventions

OTHEROropharyngeal administration of sterile water (placebo)
BIOLOGICALOropharyngeal administration of donor human milk

Sponsors

Fundação de Amparo à Pesquisa do estado de Minas Gerais
CollaboratorOTHER
Federal University of Uberlandia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
72 Hours to 5 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of late-onset sepsisan average of 3 monthsNumber of participants with late-onset sepsis
Measurement of immunologic factors in urine and blood samples using enzyme-linked immunoassay (ELISA).an average of 3 monthsELISA Index of immunologic factors in urine and blood samples

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026