Viewing Study NCT03844204



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Last Modification Date: 2024-10-26 @ 1:04 PM
Study NCT ID: NCT03844204
Status: COMPLETED
Last Update Posted: 2020-04-03
First Post: 2019-02-14

Brief Title: Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth
Sponsor: University Hospital Padova
Organization: University Hospital Padova

Study Overview

Official Title: Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth a Multicenter Prospective Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2020-04
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: SCOPRI
Brief Summary: Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved worldwide challenge

A list of interventions including adequate room temperature use of infant warmers polyethylene bagswrap pre-heated mattresses caps and heated and humidified gases to prevent thermal loss at birth in very preterm infants has been recommended but a certain percentage of very preterm infants are hypothermic at the time of the neonatal intensive care unit NICU admission suggesting that further measures are needed The thermal servo-controlled systems are routinely used in the NICU to accurately manage the patients temperature but their role during the immediate postnatal phase has not been previously assessed

We hypothesized that using a thermal servo-control system at delivery could prevent heat loss during this delicate phase and increase the percentage of very low birth weight infants VLBWI in the normal thermal range temperature 365-375C at NICU admission The aim of this study will be to compare two modes of thermal management with and without the use of a thermal servo-controlled system for preventing heat loss at birth in VLBWI infants
Detailed Description: None

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