Ignite Creation Date:
2024-05-05 @ 9:40 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00930917
Status:
COMPLETED
Last Update Posted:
2009-07-02
First Post:
2009-06-30
Brief Title:
Heat Loss Prevention in Delivery Room Using a Polyethylene Cap
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
Heat Loss Prevention in Delivery Room a Prospective Randomised Controlled Trial of Polyethylene Caps in Very Preterm Infants
Status:
COMPLETED
Status Verified Date:
2009-06
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:
It is apparent that the head of a preterm infant should not be left uncovered however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss
We conducted a prospective randomised controlled trial in very preterm infants to evaluate if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive wrapping and conventional drying Furthermore we assessed body temperature 1 hour after admission to Neonatal Intensive Care Unit NICU to evaluate whether the polyethylene cap prevents postnatal heat loss
We conducted a prospective randomised controlled trial in very preterm infants to evaluate if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive wrapping and conventional drying Furthermore we assessed body temperature 1 hour after admission to Neonatal Intensive Care Unit NICU to evaluate whether the polyethylene cap prevents postnatal heat loss
Detailed Description:
The primary outcome measure was axillary temperature taken on admission to the NICU immediately after cap and wrap removal and again 1 hour later Axillary temperature was measured using a digital thermometer Terumo Digital Clinical Thermometer C202 Terumo Corporation Tokio Japan The occurrence of hypothermia defined as axillary temperature less then 364C on NICU admission was also evaluated
Secondary outcomes included mortality prior to hospital discharge presence of major brain injury sonographic evidence of intraventricular hemorrhage with ventricular dilatation parenchymal hemorrhagic infarction or periventricular leukomalacia tracheal intubation at birth Apgar scores delivery to admission time blood gas analysis and serum glucose concentration on NICU admission
Secondary outcomes included mortality prior to hospital discharge presence of major brain injury sonographic evidence of intraventricular hemorrhage with ventricular dilatation parenchymal hemorrhagic infarction or periventricular leukomalacia tracheal intubation at birth Apgar scores delivery to admission time blood gas analysis and serum glucose concentration on NICU admission
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