Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)

Infection Clinical Trial

Official title:

Oropharyngeal Administration of Mother's Colostrum: Health Outcomes of Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116699
• Other study ID #: EH11-360
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Infection
• Pneumonia
• Pneumonia, Ventilator-Associated
• Premature Birth
• Ventilator-associated Pneumonia

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,