Oropharyngeal Administration of Colostrum
1 other identifier
interventional
145
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 27, 2016
CompletedFirst Posted
Study publicly available on registry
September 23, 2016
CompletedSeptember 23, 2016
September 1, 2016
3 years
July 27, 2016
September 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Own mother's colostrum
EXPERIMENTALOropharyngeal administration of own mother's colostrum.
Placebo
PLACEBO COMPARATOROropharyngeal administration of sterile water.
Donor human milk
ACTIVE COMPARATOROropharyngeal administration of donor human milk.
Interventions
Eligibility Criteria
You may qualify if:
- Birth weight \< 1500 g and gestational age \< 34 weeks
You may not qualify if:
- congenital anomalies
- gastrointestinal disorders
- maternal history of substance abuse or positive maternal HIV status.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 30964820DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator / Professor of Pediatrics / Head of Neonatology Division
Study Record Dates
First Submitted
July 27, 2016
First Posted
September 23, 2016
Study Start
July 1, 2013
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
September 23, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share