Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life (PREMARISQ)

August 9, 2018 updated by: Centre Hospitalier Universitaire, Amiens
Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit will be included after informing the parents. Abdominal skin and peripheral (arm or leg) and incubator air temperatures and relative humidity will be obtained from data recorded by the incubator without using any additional transducer compared to standard care. Pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization will also be recorded from routine monitoring. A case report form and a wide-angle video recording of the infant's room will allow description of the type of care, determine the duration of care and the impact on incubator function. Data will be recorded for the first 7 days of life of the preterm neonate.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit

Description

Inclusion Criteria:

  • Preterm infants of 25-32 weeks of gestation
  • Birth in one of the two maternity hospitals of Amiens agglomeration (CGO or clinic of Europe )
  • Arrived in the Neonatal Medicine unit < 2 hours of life
  • Necessitated a care in an incubator

Exclusion Criteria:

  • Preterm infants > 32 weeks of gestation
  • Birth outside the Amiens metropolitan area
  • Arrived in the Neonatal Medicine unit after 2 hours of life
  • Present a malformation syndrome or severe heart disease
  • Pathology requiring support within the first 7 days of life
  • Apgar score < 5 to 10 minutes of life
  • Need for initial management in open incubator
  • Unavailability of a type of incubator " Caleo® "

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
hypothermia
Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lowest abdominal skin temperature
Time Frame: 20 minutes
20 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
The nadir for peripheral skin temperature
Time Frame: 20 minutes
20 minutes
Pulse rate
Time Frame: 20 minutes
20 minutes
Morbidity
Time Frame: 7 days
7 days
mortality
Time Frame: 7 days
7 days
respiratory rate
Time Frame: 20 minutes
20 minutes
Blood pressure
Time Frame: 20 minutes
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Pierre TOURNEUX, MD,PhD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOL08-DR-TOURNEUX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypothermia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe