Rodriguez 2015b.

Trial name or title	Oropharyngeal administration of mother’s colostrum, health outcomes of preterm infants: study protocol for a randomised controlled trial
Methods	Prospective, multi‐centre, double‐blind, placebo‐controlled, randomised trial
Participants	Extremely preterm infants with birth weight < 1250 grams, within the infant’s first 96 hours of life Setting: 5 NICUs in hospitals within the United States 1. NorthShore University HealthSystem, Evanston, Illinois 2. Betty H. Cameron Women & Children's Hospital, New Hanover Regional Medical Center, Wilmington, North Carolina 3. St. Joseph's Children's Hospital, Paterson, New Jersey 4. Advocate Children's Hospital, Park Ridge, Illinois 5. Morristown Medical Center, Morristown, New Jersey Estimated enrolment: 622 participants, with an estimated dropout rate of 20%, allowing completed analysis of 489 participants
Interventions	Intervention group: oropharyngeal administration of mother's colostrum 1. Initial treatment with 0.2 mL of colostrum administered per dose followed by buccal swabbing for 10 seconds. The procedure is repeated 2‐hourly for 48 hours 2. Extended treatment period beginning immediately after completion of initial treatment. The procedure is repeated every 3 hours until the infant reaches 32 weeks' corrected gestational age Comparison: sterile water given by the same procedure for colostrum
Outcomes	Primary outcomes 1. Late‐onset sepsis defined as new onset of at least 2 clinical symptoms with a positive blood culture (noted after day of life 3) and identification of an organism known to be a cause of sepsis rather than a contaminant 2. NEC defined according to modified Bell's criteria stage > 2 with clinical signs and radiological evidence including any of the following: pneumatosis intestinalis or portal venous gas with or without pneumoperitoneum 3. Death Secondary outcomes Faecal microbiota, urinary biomarker of oxidative stress, concentrations of urinary lactoferrin
Starting date	November 2013
Contact information	Nancy Rodriguez; nrodriguez@northshore.org NorthShore University HealthSystem, Evanston, IL, USA
Notes	This trial is actively recruiting

IgA: immunoglobulin A.

MRSA: methicillin‐resistant Staphylococcus aureus.

NICU: neonatal intensive care unit.