Oropharyngeal Administration of Colostrum

NCT ID: NCT02912585

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-07-31

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.

Conditions

Health Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Own mother's colostrum

Oropharyngeal administration of own mother's colostrum.

Group Type: EXPERIMENTAL

Oropharyngeal administration of own mother's colostrum

Intervention Type: BIOLOGICAL

Placebo

Oropharyngeal administration of sterile water.

Group Type: PLACEBO_COMPARATOR

Oropharyngeal administration of sterile water (placebo)

Intervention Type: OTHER

Donor human milk

Oropharyngeal administration of donor human milk.

Group Type: ACTIVE_COMPARATOR

Oropharyngeal administration of donor human milk

Intervention Type: BIOLOGICAL

Interventions

Oropharyngeal administration of own mother's colostrum

Intervention Type: BIOLOGICAL

Oropharyngeal administration of sterile water (placebo)

Intervention Type: OTHER

Oropharyngeal administration of donor human milk

Intervention Type: BIOLOGICAL

Other Intervention Names

OMC Group; Placebo Group; DHM Group

Eligibility 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.

• Minimum Eligible Age: 72 Hours
• Maximum Eligible Age: 5 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role: collaborator

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

Daniela Marques de Lima Mota Ferreira

Principal Investigator / Professor of Pediatrics / Head of Neonatology Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 30964820 (View on PubMed)

Other Identifiers

CEP 333.886

Identifier Type: -

Identifier Source: org_study_id