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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02116699
Recruitment Status : Completed
First Posted : April 17, 2014
Last Update Posted : March 1, 2023
Sponsor:
Collaborators:
The Gerber Foundation
Fundacion Para La Investigacion Hospital La Fe
University of Chicago
Information provided by (Responsible Party):
NorthShore University HealthSystem

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infection Enterocolitis, Necrotizing Ventilator-associated Pneumonia Other: oropharyngeal mother's milk Other: oropharyngeal sterile water Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : November 20, 2013
Actual Primary Completion Date : October 30, 2021
Actual Study Completion Date : January 4, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence of of late-onset sepsis [ Time Frame: at 40 wks CGA ]
    positive blood cultures (not deemed contaminated) collected after 72 hours of age, and 2 clinical symptoms

  2. Incidence of necrotizing enterocolitis [ Time Frame: 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

  3. Incidence of ventilator-associated pneumonia [ Time Frame: at 40 weeks CGA ]

Secondary Outcome Measures :
  1. Time to reach full enteral feeds [ Time Frame: at 40 wks CGA ]
    defined as # days to reach a 120kcal/kg/day

  2. Length of hospital stay [ Time Frame: at 40 wks CGA ]
  3. Concentrations of lactoferrin in urine [ Time Frame: 1 day, 3 days, 32 weeks CGA ]
  4. Changes in stool microbiome [ Time Frame: 3 days, 2 weeks, 32 weeks CGA ]
  5. Changes in urinary biomarkers of oxidative stress [ Time Frame: 3 days, ]
    1 day, 3 days, 1 week, 32 weeks CGA


Eligibility Criteria
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Ages Eligible for Study:   1 Day to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116699


Locations
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United States, Florida
South Miami Hospital
Miami, Florida, United States, 33143-4679
United States, Illinois
NorthShore University health System
Evanston, Illinois, United States, 60201
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States, 60068
United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07960
United States, North Carolina
Betty Cameron Women & Children's Hospital
Wilmington, North Carolina, United States, 28403-6024
Sponsors and Collaborators
NorthShore University HealthSystem
The Gerber Foundation
Fundacion Para La Investigacion Hospital La Fe
University of Chicago
Investigators
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Principal Investigator: Nancy A Garofalo (previously Rodriguez), PhD APN NNP NorthShore University HealthSystem
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT02116699    
Other Study ID Numbers: EH11-360
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Keywords provided by NorthShore University HealthSystem:
oropharyngeal
colostrum
mother's milk
premature
neonate
infection
necrotizing enterocolitis
 ventilator-associated pneumonia
breastmilk
human milk
late-onset sepsis
microbiome
antioxidant
enteral feeds
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Ventilator-Associated
Enterocolitis
Enterocolitis, Necrotizing
Premature Birth
Infections
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Healthcare-Associated Pneumonia
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases