Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
- Conditions
- Ventilator-associated PneumoniaInfectionEnterocolitis, Necrotizing
- Interventions
- Other: oropharyngeal mother's milkOther: oropharyngeal sterile water
- Registration Number
- NCT02116699
- Lead Sponsor
- NorthShore University HealthSystem
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description oropharyngeal mother's milk oropharyngeal mother's milk 0.2 mL every 2 hours for 48 hours beginning within 96 hours post-birth, followed by 0.2 mL every 3 hours until 32 weeks post conceptional age oropharyngeal sterile water oropharyngeal sterile water 0.2 mL every 2 hours for 48 hours beginning within 96 hours post-birth, followed by 0.2 mL every 3 hours until 32 weeks post conceptional age
- Primary Outcome Measures
Name Time Method Incidence of necrotizing enterocolitis at 40 weeks CGA defined according to modified Bell's criteria stage \>2 with clinical signs and radiological evidence of pneumatosis intestinalis or portal venous gas
Incidence of ventilator-associated pneumonia at 40 weeks CGA Incidence of of late-onset sepsis at 40 wks CGA positive blood cultures (not deemed contaminated) collected after 72 hours of age, and 2 clinical symptoms
- Secondary Outcome Measures
Name Time Method Changes in stool microbiome 3 days, 2 weeks, 32 weeks CGA Length of hospital stay at 40 wks CGA Time to reach full enteral feeds at 40 wks CGA defined as # days to reach a 120kcal/kg/day
Concentrations of lactoferrin in urine 1 day, 3 days, 32 weeks CGA Changes in urinary biomarkers of oxidative stress 3 days, 1 day, 3 days, 1 week, 32 weeks CGA
Trial Locations
- Locations (5)
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Betty Cameron Women & Children's Hospital
🇺🇸Wilmington, North Carolina, United States
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