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Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants Clinical research trials and Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants. Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants  Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants
Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants
For Condition: Necrotizing Enterocolitis,Sepsis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Baylor College of Medicine
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind
Minimum Age/Maximum Age: /96 Hours
Genders: Both
Protocol Entry Criteria: - 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
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
RichardSchanler, Study Chair, Baylor College of Medicine
Baylor College of Medicine
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: 199/15024; BCM-H5433
Study Start Date: January 1997
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005888
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Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants
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