Sepsis Clinical Trial
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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