Infection Clinical Trial
Official title:
Oropharyngeal Administration of Mother's Colostrum: Health Outcomes of Premature Infants
Verified date | February 2023 |
Source | NorthShore University HealthSystem |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 260 |
Est. completion date | January 4, 2022 |
Est. primary completion date | October 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 4 Days |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | NorthShore University health System | Evanston | Illinois |
United States | South Miami Hospital | Miami | Florida |
United States | Morristown Medical Center | Morristown | New Jersey |
United States | Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois |
United States | Betty Cameron Women & Children's Hospital | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
NorthShore University HealthSystem | Fundacion Para La Investigacion Hospital La Fe, The Gerber Foundation, University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of of late-onset sepsis | positive blood cultures (not deemed contaminated) collected after 72 hours of age, and 2 clinical symptoms | at 40 wks CGA | |
Primary | Incidence of necrotizing enterocolitis | defined according to modified Bell's criteria stage >2 with clinical signs and radiological evidence of pneumatosis intestinalis or portal venous gas | at 40 weeks CGA | |
Primary | Incidence of ventilator-associated pneumonia | at 40 weeks CGA | ||
Secondary | Time to reach full enteral feeds | defined as # days to reach a 120kcal/kg/day | at 40 wks CGA | |
Secondary | Length of hospital stay | at 40 wks CGA | ||
Secondary | Concentrations of lactoferrin in urine | 1 day, 3 days, 32 weeks CGA | ||
Secondary | Changes in stool microbiome | 3 days, 2 weeks, 32 weeks CGA | ||
Secondary | Changes in urinary biomarkers of oxidative stress | 1 day, 3 days, 1 week, 32 weeks CGA | 3 days, |
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