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Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants

Primary Purpose

Necrotizing Enterocolitis, Sepsis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fortified Pasteurized Donor Human Milk supplement
Preterm Formula supplement
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotizing Enterocolitis focused on measuring gastrointestinal disorders, immunologic disorders and infectious disorders, low birth weight, necrotizing enterocolitis, neonatal disorders, rare disease, sepsis

Eligibility Criteria

0 Years - 96 Hours (Child)All SexesDoes not accept healthy volunteers

Infants of less than 30 weeks gestational age Less than 96 hours after birth No HIV positive mothers who plan to nurse No major congenital malformations

Sites / Locations

  • Baylor College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00005888
Brief Title
Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Baylor College of Medicine

4. Oversight

5. Study Description

Brief Summary
OBJECTIVES: I. Compare the incidence of late onset sepsis and/or necrotizing enterocolitis and duration of hospitalization in low birth weight infants fed with fortified mother's milk supplemented with either fortified pasteurized donor human milk or preterm formula, and with fortified mother's milk versus preterm formula. II. Determine the relationship between functional antibody titers in serial milk samples and the incidence of pathogen specific late onset sepsis (e.g., Staphylococcus epidermidis, Staphylococcus aureus) in these patients. III. Determine the long term sequelae (growth, body composition, health, and neurodevelopment) of human milk versus formula feeding in these patients. IV. Determine the relationship between stress and milk production in the mothers of these patients.
Detailed Description
PROTOCOL OUTLINE: This is a randomized, double blind study in arms I and II. Patients are randomized to receive either fortified pasteurized donor human milk (arm I) or preterm formula (arm II) as a supplement to mother's milk, if needed. Patients are stratified according to gestational age (less than 26 weeks vs 27-29 weeks) and prior antenatal steroids (yes vs no). Patients are also assigned to groups receiving fortified mother's milk (arm III) and preterm formula only (arm IV). Milk samples are obtained from the patient's mother for analyses of functional antibody against Staphylococcus epidermidis and Staphylococcus aureus; bacterial culture and sensitivity; bacterial colony count; and immunoglobulin and nutrient composition (i.e., energy, protein). Maternal blood samples to measure functional antibody are obtained every 2 weeks throughout hospitalization as long as infant is receiving own mother's milk. Cord blood is obtained at delivery. Patients are studied at 40 week postmenstrual age, and then every 6 months for 3 years. Records of health (e.g., number of doctor, clinic, and emergency room visits; hospitalizations; and illnesses), dietary intake, and growth are collected. Urine is collected every 2 weeks to monitor infection. Neurodevelopment is assessed at 3 years using the McCarthy Scales of Infant Development. Mothers who plan to nurse their infants after hospital discharge complete the STAI "trait" form at beginning of study. Mothers are assessed weekly for 6 weeks postpartum, and every other week thereafter as long as they are expressing milk by mechanical means only. Following a session of skin to skin contact, the number of milk expressions, the duration of each pumping, and a 24 hour milk collection is obtained. Mothers also complete the Spielberger State Trait Anxiety Inventory, STAI, Beck Depression Inventory, Norbeck Social Support questionnaire, Parental Stressor Scale, and the Neonatal Perception Inventory during each 24 hour milk collection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis, Sepsis
Keywords
gastrointestinal disorders, immunologic disorders and infectious disorders, low birth weight, necrotizing enterocolitis, neonatal disorders, rare disease, sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Fortified Pasteurized Donor Human Milk supplement
Intervention Type
Behavioral
Intervention Name(s)
Preterm Formula supplement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
96 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Infants of less than 30 weeks gestational age Less than 96 hours after birth No HIV positive mothers who plan to nurse No major congenital malformations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J. Schanler
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants

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