Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005888
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-06-02
Brief Title:
Study of the Relationship Between Feeding and Late Onset Sepsis andor Necrotizing Enterocolitis in Low Birth Weight Infants
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Compare the incidence of late onset sepsis andor necrotizing enterocolitis and duration of hospitalization in low birth weight infants fed with fortified mothers milk supplemented with either fortified pasteurized donor human milk or preterm formula and with fortified mothers 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 eg 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
II Determine the relationship between functional antibody titers in serial milk samples and the incidence of pathogen specific late onset sepsis eg 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 mothers 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 mothers milk arm III and preterm formula only arm IV
Milk samples are obtained from the patients mother for analyses of functional antibody against Staphylococcus epidermidis and Staphylococcus aureus bacterial culture and sensitivity bacterial colony count and immunoglobulin and nutrient composition ie energy protein Maternal blood samples to measure functional antibody are obtained every 2 weeks throughout hospitalization as long as infant is receiving own mothers 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 eg 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
Milk samples are obtained from the patients mother for analyses of functional antibody against Staphylococcus epidermidis and Staphylococcus aureus bacterial culture and sensitivity bacterial colony count and immunoglobulin and nutrient composition ie energy protein Maternal blood samples to measure functional antibody are obtained every 2 weeks throughout hospitalization as long as infant is receiving own mothers 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 eg 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCM-H5433 | None | None | None |