CompletedNot Applicable

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

United States260 participantsStarted 2013-11-20

Plain-language 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.

Who can participate

Age range1 Day – 4 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Exclusion Criteria: 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

What they're measuring

Incidence of of late-onset sepsis

Timeframe: at 40 wks CGA

Incidence of necrotizing enterocolitis

Timeframe: at 40 weeks CGA

Incidence of ventilator-associated pneumonia

Timeframe: at 40 weeks CGA

Trial details

NCT IDNCT02116699

SponsorEndeavor Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-30

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