Ignite Creation Date:
2024-05-06 @ 12:52 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01671241
Status:
UNKNOWN
Last Update Posted:
2012-08-23
First Post:
2012-07-17
Brief Title:
Heat Loss Prevention in Very Preterm Infants in Delivery Rooms A Multicenter Randomized Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2012-08
Last Known Status:
RECRUITING
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:
Hypothermia after delivery is a world-wide problem associated with morbidity and mortality The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is unsuccessful in a large proportion of very preterm infants Polyethylene occlusive skin wrapping covering the infants body up to the neck will reduce postnatal heat loss in very preterm babies and represents the standard of care recommended by the International Guidelines for Neonatal Resuscitation The use of a polyethylene head cap will also reduce heat loss 9 and its efficacy is comparable to that obtained with the wrap However the proportions of hypothermic infants at NICU admission temperature 34C in the wrapped group 62 as well as in the infants covered with a polyethylene cap 43 remain high The combination of body and head protection with a polyethylene wrap needs to be evaluated further The investigators conducted a prospective randomized controlled trial in very preterm infants to evaluate whether a polyethylene total body wrapping body plus head prevents heat loss after delivery better than polyethylene occlusive wrapping
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None