Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants
Condition: Necrotizing Enterocolitis; Sepsis
MeSH terms: Sepsis; Enterocolitis; Enterocolitis, Necrotizing; Birth Weight
Study type: Interventional

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.
    

Intervention name(s): Fortified Pasteurized Donor Human Milk supplement; Preterm Formula supplement
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: gastrointestinal disorders; immunologic disorders and infectious disorders; low birth weight; necrotizing enterocolitis; neonatal disorders; rare disease; sepsis