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Search / Trial NCT03919188

Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Apr 15, 2019

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Preterm Neonates Incubator Management Body Temperature Relative Air Humidity Thermoneutrality

ClinConnect Summary

This clinical trial is investigating how different methods of controlling temperature in incubators can affect the growth and health of preterm infants born between 25 and 32 weeks of gestation. The researchers want to find out if using a special software that calculates the best air temperature for each baby can help them grow better during their first 10 days of life, compared to a traditional method that uses skin temperature as a guide. The study aims to see if this new approach can also reduce health problems that preterm infants often face.

To be part of this study, infants must be born very early (between 25 and 32 weeks) and be included in the trial within the first day of their lives. They will be cared for in a closed incubator, and parents will need to give their written consent for their baby's participation. The researchers hope to enroll several infants and will monitor their growth and health closely throughout the trial. This study could provide valuable information on how to better care for preterm babies and improve their chances of healthy development.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • preterm infant born between 25+0 and 32+0 weeks of gestation
  • preterm infant included in the study before 24 +/- 12 hours of life
  • preterm infant nursed in a closed incubator
  • written informed consent from his parents
  • Exclusion Criteria:
  • newborn infant with polymalformative syndrome
  • life threatening events or serious heart disease

About Centre Hospitalier Universitaire, Amiens

The Centre Hospitalier Universitaire (CHU) Amiens is a leading academic medical center in France dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on multidisciplinary collaboration, CHU Amiens integrates patient care, education, and research to enhance treatment outcomes and improve patient quality of life. The institution is committed to ethical standards and regulatory compliance in its clinical research endeavors, aiming to contribute significantly to the medical community and the development of new therapeutic approaches. By fostering partnerships with various stakeholders, CHU Amiens strives to translate scientific discoveries into practical applications that benefit patients and healthcare systems alike.

Locations

Amiens, Picardie, France

Patients applied

0 patients applied

Trial Officials

Alexandre Cénéric, Dr

Principal Investigator

CHU CAEN

Kévin Leduc, Dr

Principal Investigator

CHRU LILLE

Sophie Galène, MD

Principal Investigator

CHU Rouen

Guillaume ESCOURROU, MD

Principal Investigator

CHI André Grégoire - Montreuil

Julien Ghesquière, MD

Principal Investigator

CH Arras

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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