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

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. Identifier: NCT00005888
Recruitment Status : Completed
First Posted : June 5, 2000
Last Update Posted : June 24, 2005
Baylor College of Medicine
Information provided by:
National Center for Research Resources (NCRR)

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.

Condition or disease Intervention/treatment Phase
Necrotizing Enterocolitis Sepsis Behavioral: Fortified Pasteurized Donor Human Milk supplement Behavioral: Preterm Formula supplement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight Sepsis

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 96 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

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 identifier (NCT number): NCT00005888

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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Baylor College of Medicine
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Study Chair: Richard J. Schanler Baylor College of Medicine

Layout table for additonal information Identifier: NCT00005888     History of Changes
Other Study ID Numbers: 199/15024
First Posted: June 5, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2002
Keywords provided by National Center for Research Resources (NCRR):
gastrointestinal disorders
immunologic disorders and infectious disorders
low birth weight
necrotizing enterocolitis
neonatal disorders
rare disease
Additional relevant MeSH terms:
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Enterocolitis, Necrotizing
Birth Weight
Systemic Inflammatory Response Syndrome
Pathologic Processes
Body Weight
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases