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

NCT03919188 | Recruiting

• 1 other identifier: PI2018_843_0056
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies have shown that mortality and morbidity in preterm neonates are correlated with the fall in body temperature on admission. Hypothermia can be decreased by reducing body heat losses to the environment. The investigator research hypothesis is that a new calculation of the air temperature in the incubator would promote the newborn infant weight growth from the period between birth and day 10 of life compared to cutaneous mode. The secondary hypotheses assumes a decrease in the side effects usually observed in both morbidity and mortality. A software is used to calculate the body heat loss (BHL) of each individual preterm infant, and to propose a specific air temperature setting inside the incubator to reduce BHL to zero. This software has been validated in a previous pilot study (Degorre et al. 2015). This study aims to compare the energy costs of providing incubated preterm infants born between 25 and 32 weeks of gestation with homeothermia using either specific individualized air temperature control (ATC) or skin servocontrol (SSC).

Conditions

Preterm Infant; Body Temperature

Keywords

preterm neonates; incubator management; body temperature; relative air humidity; thermoneutrality

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Change in body weight between birth and day 10 of life

  until day 10 of life

Secondary Outcomes (5)

• Comfort of the preterm infant

  until day 10 of life

• thermal stress occurence

  until day 10 of life

• humidity challenge using TEWL

  until day 10 of life

• neonatal morbidity occurence

  until age corresponding to 40 weeks of amenorrhea

• length of hospitalization stay

  until age corresponding to 40 weeks of amenorrhea or end of hospitalization

Study Arms (2)

air temperature control (ATC)

ACTIVE COMPARATOR

Incubator control using air temperature control (ATC) method

Procedure: air temperature control (ATC)

skin servocontrol (SSC)

ACTIVE COMPARATOR

Incubator control using skin servocontrol method

Procedure: skin servocontrol (SSC)

Interventions

air temperature control (ATC) PROCEDURE

Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): second parameter : air temperature control (ATC)

air temperature control (ATC)

skin servocontrol (SSC) PROCEDURE

Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): Third parameter : skin servocontrol (SSC).

skin servocontrol (SSC)

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• newborn infant with polymalformative syndrome
• life threatening events or serious heart disease

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• University Hospital, Rouen: collaborator
• University Hospital, Caen: collaborator
• University Hospital, Lille: collaborator
• Centre Hospitalier Arras: collaborator
• Centre Hospitalier de Montreuil: collaborator

Study Sites (1)

Amiens University Hospital

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Alexandre Cénéric, Dr

  CHU CAEN

  PRINCIPAL INVESTIGATOR

• Kévin Leduc, Dr

  CHRU LILLE

  PRINCIPAL INVESTIGATOR

• Sophie Galène, MD

  CHU Rouen

  PRINCIPAL INVESTIGATOR

• Guillaume ESCOURROU, MD

  CHI André Grégoire - Montreuil

  PRINCIPAL INVESTIGATOR

• Julien Ghesquière, MD

  CH Arras

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Tourneux, Pr

CONTACT

(33)322087604; tourneux.pierre@chu-amiens.fr

Momar Diouf, Dr

CONTACT

(33)322088371; diouf.momar@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 18, 2019
• Study Start: January 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)