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Completed

NCT Number: NCT02798926

Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?

Particular attention is paid to thermal management of preterm neonates in neonatal intensive care units because of the major risk of morbidity associated with hypothermia. Percutaneous central venous catheter placement is essential to ensure adequate caloric intake and intravenous administration of treatments, but this procedure can cause major body temperature variations, responsible for complications in these neonates, as convection incubator function is impaired during opening of the incubator, which can be prolonged (30 minutes to 2 hours) depending on the technical difficulties encountered during catheter placement.

In parallel, the use of a polyethylene bag or sheet in the delivery room and for neonatal transport is now clearly defined and ensures stability or even a considerable temperature gain during transfer immediately after birth. In the light of several clinical cases, the use of a polyethylene bag during central venous catheter placement appears to be effective to prevent body temperature loss in preterm neonates. No data are currently available concerning the value of this method of prevention of hypothermia during this type of procedure.

Preliminary studies conducted by our team on a dummy suggest that a polyethylene bag or sheet could be useful during this procedure by significantly reducing heat loss caused by convection and evaporation. However, compensation phenomena such as generalized vasoconstriction to cold in preterm infants are very poorly described, but can induce a functional conflict between mechanisms ensuring maintenance of homeostasis and those involved in maintenance of blood pressure.

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Key information

Age range

0 day–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • premature Newborn child = 32 weeks of gestational age
  • 7 days of life
  • Normothermic (core temperature between 36.5 and 37.5 ° C)
  • Stable on a hemodynamically manner
  • Need the installation of a central catheter KTEC

Exclusion criteria

  • Parental Refusal
  • hypothermia (temperature < 36.5 ° C)
  • Hyperthermia (temperature > 37.5 ° C)
  • heart disease and malformation syndromes life-threatening
  • Hemodynamic instability ( catecholamine vasoconstrictor and vasodilator )
  • Breakdown by oscillation

Treatment and study plan

polyethylene bag

Device

The infant will be wrapped in a polyethylene bag 15 min before starting central venous catheter placement

Primary outcomes

  1. Temperature

    Time frame: 1 hour

    difference between the prehepatic temperature at the beginning of catheter placement and the lowest temperature observed during the procedure

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: PSac

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2016
Registry last updated
Jun 12, 2026

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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