Clinical trial NCT02116699: Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
Official title: Oropharyngeal Administration of Mother's Colostrum: Health Outcomes of Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Enterocolitis, Necrotizing
Ventilator-associated Pneumonia
Keywords: oropharyngeal
colostrum
mother's milk
premature
neonate
infection
necrotizing enterocolitis
ventilator-associated pneumonia
breastmilk
human milk
late-onset sepsis
microbiome
antioxidant
enteral feeds
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
name: Fundacion Para La Investigacion Hospital La Fe
name: University of Chicago
First posted: 2014-04-17
Enrollment: 260
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of of late-onset sepsis
timeFrame: at 40 wks CGA
measure: Incidence of necrotizing enterocolitis
timeFrame: at 40 weeks CGA
measure: Incidence of ventilator-associated pneumonia
timeFrame: at 40 weeks CGA
Secondary outcomes:
measure: Time to reach full enteral feeds
timeFrame: at 40 wks CGA
measure: Length of hospital stay
timeFrame: at 40 wks CGA
measure: Concentrations of lactoferrin in urine
timeFrame: 1 day, 3 days, 32 weeks CGA
measure: Changes in stool microbiome
timeFrame: 3 days, 2 weeks, 32 weeks CGA
measure: Changes in urinary biomarkers of oxidative stress
timeFrame: 3 days,
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Miami Hospital
state: Florida
city: Evanston
country: United States
facility: NorthShore University health System
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Children's Hospital-Park Ridge
state: Illinois
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Wilmington
country: United States
facility: Betty Cameron Women & Children's Hospital
state: North Carolina
Study officials:
affiliation: Endeavor Health
name: Nancy A Garofalo (previously Rodriguez), PhD APN NNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez NA, Vento M, Claud EC, Wang CE, Caplan MS. Oropharyngeal administration of mother's colostrum, health outcomes of premature infants: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:453. doi: 10.1186/s13063-015-0969-6.