CClinicalTrials.gg
CompletedNCT02798926PSacUpdated Jun 12, 2026

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

An observational study in Preterm Neonates, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 0 Days to 7 Days. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
63
Ages
0 Days to 7 Days
Sex
All
01

Study summary

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.

02

Conditions studied

  • Preterm Neonates

Browse trials for

Keywords

  • hypothermia
  • central venous catheter placement
  • Polyethylene bag
03

In context

Hypothermia

499 studies on the registry are indexed under Hypothermia; 53 are open to participants now.

This study's enrollment of 63 is below the median of 97 across 126 observational studies indexed under Hypothermia.

Browse Hypothermia studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days to 7 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

preterm neonates less than 32 weeks of gestational age (WGA)

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No

Groups and cohorts

  • with the use of a polyethylene bag

    Device: polyethylene bag

  • without the use of a polyethylene bag

Interventions

  • Devicepolyethylene bag

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

06

What researchers measure

Primary outcomes

  1. Temperature

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

    Time frame: 1 hour

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80054, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02798926
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jun 14, 2016
Start date
Jun 19, 2014
Primary completion
Aug 23, 2022
Completion
Aug 23, 2022
Last update
Jun 12, 2026

Study contacts

Laurent GHYSELEN, PhD
principal investigator · CHU Amiens
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion