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

Primary Purpose

Infection, Enterocolitis, Necrotizing, Ventilator-associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
oropharyngeal mother's milk
oropharyngeal sterile water
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection focused on measuring oropharyngeal, colostrum, mother's milk, premature, neonate, infection, necrotizing enterocolitis, ventilator-associated pneumonia, breastmilk, human milk, late-onset sepsis, microbiome, antioxidant, enteral feeds

Eligibility Criteria

1 Day - 4 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • South Miami Hospital
  • NorthShore University health System
  • Advocate Children's Hospital-Park Ridge
  • Morristown Medical Center
  • Betty Cameron Women & Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

oropharyngeal mother's milk

oropharyngeal sterile water

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of of late-onset sepsis
positive blood cultures (not deemed contaminated) collected after 72 hours of age, and 2 clinical symptoms
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
Incidence of ventilator-associated pneumonia

Secondary Outcome Measures

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

Full Information

First Posted
April 11, 2014
Last Updated
February 27, 2023
Sponsor
NorthShore University HealthSystem
Collaborators
The Gerber Foundation, Fundacion Para La Investigacion Hospital La Fe, University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02116699
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2013 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
January 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NorthShore University HealthSystem
Collaborators
The Gerber Foundation, Fundacion Para La Investigacion Hospital La Fe, University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oropharyngeal mother's milk
Arm Type
Experimental
Arm Description
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
Arm Title
oropharyngeal sterile water
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
oropharyngeal mother's milk
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
oropharyngeal sterile water
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of of late-onset sepsis
Description
positive blood cultures (not deemed contaminated) collected after 72 hours of age, and 2 clinical symptoms
Time Frame
at 40 wks CGA
Title
Incidence of necrotizing enterocolitis
Description
defined according to modified Bell's criteria stage >2 with clinical signs and radiological evidence of pneumatosis intestinalis or portal venous gas
Time Frame
at 40 weeks CGA
Title
Incidence of ventilator-associated pneumonia
Time Frame
at 40 weeks CGA
Secondary Outcome Measure Information:
Title
Time to reach full enteral feeds
Description
defined as # days to reach a 120kcal/kg/day
Time Frame
at 40 wks CGA
Title
Length of hospital stay
Time Frame
at 40 wks CGA
Title
Concentrations of lactoferrin in urine
Time Frame
1 day, 3 days, 32 weeks CGA
Title
Changes in stool microbiome
Time Frame
3 days, 2 weeks, 32 weeks CGA
Title
Changes in urinary biomarkers of oxidative stress
Description
1 day, 3 days, 1 week, 32 weeks CGA
Time Frame
3 days,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
4 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A Garofalo (previously Rodriguez), PhD APN NNP
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33143-4679
Country
United States
Facility Name
NorthShore University health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Advocate Children's Hospital-Park Ridge
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Betty Cameron Women & Children's Hospital
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403-6024
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
26458907
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.
Results Reference
derived

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

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