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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Preterm Infant; Body Temperature
• Intervention / Treatment: Procedure: air temperature control (ATC); Procedure: skin servocontrol (SSC)

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Tourneux, Pr; Phone Number: (33)322087604; Email: tourneux.pierre@chu-amiens.fr
• Study Contact Backup: Name: Momar Diouf, Dr; Phone Number: (33)322088371; Email: diouf.momar@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • Amiens University Hospital
      • Contact: Pierre Tourneux, MD; Phone Number: +33 3 22 66 82 86; Email: tourneux.pierre@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: air temperature control (ATC); Incubator control using air temperature control (ATC) method	Procedure: air temperature control (ATC); 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)
Active Comparator: skin servocontrol (SSC); Incubator control using skin servocontrol method	Procedure: skin servocontrol (SSC); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Change in body weight between birth and day 10 of life	until day 10 of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort of the preterm infant	Comfort of the preterm infant will be estimated by using the newborn infant physical examination (NIPE)	until day 10 of life
thermal stress occurence	Thermal stress are hyperthermia rate, hypothermia rate, mean time in thermal comfort= thermal challenge	until day 10 of life
humidity challenge using TEWL	TEWL = transepidermal water loss. It is a daily skin monitoring of hydric loss	until day 10 of life
neonatal morbidity occurence	neonatal morbidities are infectious rate, necrotizing enterocolitis (NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary dysplasia (BPD) and death	until age corresponding to 40 weeks of amenorrhea
length of hospitalization stay	length of hospitalization stay (number of days of hospitalization)	until age corresponding to 40 weeks of amenorrhea or end of hospitalization

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Rouen; University Hospital, Caen; University Hospital, Lille; Centre Hospitalier Arras; Centre Hospitalier de Montreuil
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: preterm neonates; body temperature; incubator management; relative air humidity; thermoneutrality
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: PI2018_843_0056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No