Oropharyngeal Administration of Mother's Colostrum for Premature Infants

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. This 5-year
placebo-controlled, double-blind randomized controlled trial will evaluate the safety,
efficacy and health outcomes of oropharyngeal administration of OMC/OMM in a sample of 622
(total patients enrolled) extremely premature infants with the following aims: Aim 1. To
determine if oropharyngeal administration of OMC/OMM to extremely premature infants will
reduce the risk of late-onset sepsis or death as the primary outcome, and necrotizing
enterocolitis and ventilator-associated pneumonia as pre-planned secondary outcomes. Aim 2:
To determine if extremely premature infants who receive OMC/OMM via the oropharyngeal route
have a shorter time to reach full enteral feeds and a shorter length of hospital stay. Aim 3:
To determine if oropharyngeal administration of OMC/OMM will have immunostimulatory effects
for extremely premature infants, as measured by (A) enhancement of gastrointestinal (fecal)
microbiota, (B) improvement in antioxidant defense maturation or reduction of pro-oxidant
status, and (C) maturation of immunostimulatory effects as measured by changes in urinary
lactoferrin. Results will confirm whether extremely premature infants demonstrate a
host-immune response to this intervention and whether there is a beneficial effect on common
morbidities in these high risk patients.

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