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Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)

NCT02116699 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2023-03-01

No results posted yet for this study

Summary

Extremely premature (BW\<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. The investigators hypothesize that infants who receive oropharyngeal mother's colostrum and milk will have significantly lower rates of infection and improved health outcomes, compared to infants who receive a placebo.

Conditions

  • Infection
  • Enterocolitis, Necrotizing
  • Ventilator-associated Pneumonia

Interventions

OTHER

oropharyngeal mother's milk

Application of 0.2 mL of own mother's milk onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age

OTHER

oropharyngeal sterile water

Application of 0.2 mL of sterile water onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • Fundacion Para La Investigacion Hospital La Fe

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Nancy A Garofalo (previously Rodriguez), PhD APN NNP · Endeavor Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
4 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-20
Primary Completion
2021-10-30
Completion
2022-01-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116699 on ClinicalTrials.gov