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

NCT00005888 | Completed

• 2 other identifiers: 199/15024BCM-H5433
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Enterocolitis; Sepsis

Keywords

gastrointestinal disorders; immunologic disorders and infectious disorders; low birth weight; necrotizing enterocolitis; neonatal disorders; rare disease; sepsis

Interventions

Fortified Pasteurized Donor Human Milk supplement BEHAVIORAL

Preterm Formula supplement BEHAVIORAL

Eligibility Criteria

• Age: 0 Years - 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Sepsis; Gastrointestinal Diseases; Immune System Diseases; Communicable Diseases; Infant, Newborn, Diseases; Rare Diseases

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Digestive System Diseases; Intestinal Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Richard J. Schanler

  Baylor College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: June 5, 2000
• Study Start: January 1, 1997
• Last Updated: June 24, 2005

Record last verified: 2002-04

Locations

US (1)