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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02798926
Acronym
PSac
Enrollment
63
Registered
2016-06-14
Start date
2014-06-19
Completion date
2022-08-23
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Neonates

Keywords

hypothermia, central venous catheter placement, Polyethylene bag

Brief 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.

Interventions

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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 7 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Temperature1 hourdifference between the prehepatic temperature at the beginning of catheter placement and the lowest temperature observed during the procedure

Countries

France

Contacts

PRINCIPAL_INVESTIGATORLaurent GHYSELEN, PhD

CHU Amiens

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026