- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00005888
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Texas
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Houston, Texas, Stati Uniti, 77030
- Baylor College of Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Mascheramento: Doppio
Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: Richard J. Schanler, Baylor College of Medicine
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Maggiori informazioni
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Altri numeri di identificazione dello studio
- 199/15024
- BCM-H5433
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .