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

Not Applicable

Recruiting

• Conditions: Preterm Infant; Body Temperature
• Interventions: Procedure: air temperature control (ATC); Procedure: skin servocontrol (SSC)

• Registration Number: NCT03919188
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-18
• Study Start: 2022-01-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
air temperature control (ATC)	air temperature control (ATC)	Incubator control using air temperature control (ATC) method
skin servocontrol (SSC)	skin servocontrol (SSC)	Incubator control using skin servocontrol method

Primary Outcome Measures

Name	Time	Method
Change in body weight	until day 10 of life	Change in body weight between birth and day 10 of life

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Amiens University Hospital; 🇫🇷 Amiens, Picardie, France