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

Preterm Infant Clinical Trial

— ThermoKPreterm  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03919188
• Other study ID #: PI2018_843_0056
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Pierre Tourneux, Pr
• Phone: (33)322087604
• Email: tourneux.pierre[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature
• Premature Birth
• Preterm Infant

Intervention

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)
• 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).

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens	Picardie

Sponsors (6)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre Hospitalier Arras, Centre Hospitalier de Montreuil, University Hospital, Caen, University Hospital, Lille, University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Change in body weight between birth and day 10 of life	until day 10 of life
Secondary	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
Secondary	thermal stress occurence	Thermal stress are hyperthermia rate, hypothermia rate, mean time in thermal comfort= thermal challenge	until day 10 of life
Secondary	humidity challenge using TEWL	TEWL = transepidermal water loss. It is a daily skin monitoring of hydric loss	until day 10 of life
Secondary	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
Secondary	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