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NCT Number: NCT03919188

Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in 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).

Recruiting

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Key information

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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).

Primary outcomes

  1. Change in body weight

    Time frame: until day 10 of life

    Change in body weight between birth and day 10 of life

Secondary outcomes

  1. Comfort of the preterm infant

    Time frame: until day 10 of life

    Comfort of the preterm infant will be estimated by using the newborn infant physical examination (NIPE)

  2. thermal stress occurence

    Time frame: until day 10 of life

    Thermal stress are hyperthermia rate, hypothermia rate, mean time in thermal comfort= thermal challenge

  3. humidity challenge using TEWL

    Time frame: until day 10 of life

    TEWL = transepidermal water loss. It is a daily skin monitoring of hydric loss

  4. neonatal morbidity occurence

    Time frame: until age corresponding to 40 weeks of amenorrhea

    neonatal morbidities are infectious rate, necrotizing enterocolitis (NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary dysplasia (BPD) and death

  5. length of hospitalization stay

    Time frame: until age corresponding to 40 weeks of amenorrhea or end of hospitalization

    length of hospitalization stay (number of days of hospitalization)

Study contacts

Contact information is provided by the study sponsor or research team.

Momar Diouf, Dr

CONTACT

[email protected]

(33)322088371

Pierre Tourneux, Pr

CONTACT

[email protected]

(33)322087604

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Centre Hospitalier Arras
  • Centre Hospitalier de Montreuil
  • University Hospital, Caen
  • University Hospital, Lille
  • University Hospital, Rouen

Registry information

Official study title

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

Acronym: ThermoKPreterm

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2019
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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