Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
Completed · Not applicable
Conditions studied: Infection, Enterocolitis, Necrotizing, Ventilator-associated Pneumonia
In brief
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.
Key facts
- Study ID
- NCT02116699
- Run by
- Endeavor Health
- People needed
- 260
- Starts
- 2013-11-20
- Expected to finish
- 2022-01-04
- Last updated by the study team
- 2023-03-01
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Birthweight <1250g Mother plans to pump and provide breastmilk for at least 2 months Absence of severe congenital anomalies Admission to the neonatal intensive care unit within 24 hours after birth Ability to begin protocol within 96 hours of life
You may not qualify if…
- Gastrointestinal anomaly pH < 7.0 on initial blood gas in NICU Maternal +HIV status Maternal drug or substance use that precludes infant from receiving mother's milk Tracheoesophageal fistula
Where it is running
- South Miami Hospital — Miami, Florida, United States
- NorthShore University health System — Evanston, Illinois, United States
- Advocate Children's Hospital-Park Ridge — Park Ridge, Illinois, United States
- Morristown Medical Center — Morristown, New Jersey, United States
- Betty Cameron Women & Children's Hospital — Wilmington, North Carolina, United States
Full record on ClinicalTrials.gov
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