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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02116699
Other study ID # EH11-360
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2013
Est. completion date January 4, 2022

Study information

Verified date February 2023
Source NorthShore University HealthSystem
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Intervention

Other:
oropharyngeal mother's milk
Application of 0.2 mL of own mother's milk onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age
oropharyngeal sterile water
Application of 0.2 mL of sterile water onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age

Locations

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

Sponsors (4)

Lead Sponsor Collaborator
NorthShore University HealthSystem Fundacion Para La Investigacion Hospital La Fe, The Gerber Foundation, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

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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