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

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.

Completed

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Key information

Conditions

Necrotizing Enterocolitis Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Disease Attributes Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Immune System Diseases Infant, Newborn, Diseases Infections Inflammation Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Sepsis Systemic Inflammatory Response Syndrome

Age range

0 year–96 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fortified Pasteurized Donor Human Milk supplement

Behavioral

Preterm Formula supplement

Behavioral

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

Baylor College of Medicine

Registry information

Important dates

Study start: 1997
First posted: Jun 5, 2000
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed