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

Sponsor

NorthShore University HealthSystem (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02116699

Collaborator

The Gerber Foundation (Other), Fundacion Para La Investigacion Hospital La Fe (Other), University of Chicago (Other)

260

Enrollment

Locations

Arms

107.3

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Infection Enterocolitis, Necrotizing Ventilator-associated Pneumonia	Other: oropharyngeal mother's milk Other: oropharyngeal sterile water	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 20, 2013

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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
Placebo Comparator: 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	Other: 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

Arm

Intervention/Treatment

Experimental: 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

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

Placebo Comparator: 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

Other: 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

Outcome Measures

Primary Outcome Measures

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
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]

Secondary Outcome Measures

Time to reach full enteral feeds [at 40 wks CGA]
defined as # days to reach a 120kcal/kg/day
Length of hospital stay [at 40 wks CGA]
Concentrations of lactoferrin in urine [1 day, 3 days, 32 weeks CGA]
Changes in stool microbiome [3 days, 2 weeks, 32 weeks CGA]
Changes in urinary biomarkers of oxidative stress [3 days,]
1 day, 3 days, 1 week, 32 weeks CGA

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 4 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Miami Hospital	Miami	Florida	United States	33143-4679
2	NorthShore University health System	Evanston	Illinois	United States	60201
3	Advocate Children's Hospital-Park Ridge	Park Ridge	Illinois	United States	60068
4	Morristown Medical Center	Morristown	New Jersey	United States	07960
5	Betty Cameron Women & Children's Hospital	Wilmington	North Carolina	United States	28403-6024