Ignite Creation Date:
2024-05-06 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03344991
Status:
WITHDRAWN
Last Update Posted:
2021-10-26
First Post:
2017-11-14
Brief Title:
Cardboard Cot Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Cardboard Cot in Neonatal Thermoregulation Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Infants with an estimated gestational age 36 67 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available or who are delivered in a setting where an incubator is not available will be randomized to either standard protocol of open crib or mylar-lined cardboard cot for the duration of the hospital stay Axillary temperatures will be taken 1 hr 6 hrs and 24 hours after being placed in the cot or crib and then once every 24 hours All other care is provided as standard of care
Detailed Description:
Following parental consent preterm infants with an estimated gestational age 36 67 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available or who are in the newborn ICU in a setting where an incubator is not available will be randomized to to transfer either standard protocol of open crib or mylar-lined cardboard cot when their temperatures are stable for transfer The infants will remain in the cot or crib for the duration of the hospital stay Axillary temperatures will be taken 1 hr 6 hrs and 24 hours after being placed in the cot or crib and then once every 24 hours All other care is provided as standard of care including WHO warm chain thermoregulation guidelines of early and exclusive breastfeeding appropriate bundling and Kangaroo Mother Care as continuously as possible
If at any point a babies becomes moderately 320-359 C or severely hypothermic 320 C an extra blanket will be added to their bodies and a hat placed on their heads
If at any point a babies becomes moderately 320-359 C or severely hypothermic 320 C an extra blanket will be added to their bodies and a hat placed on their heads
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None