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

• Conditions: Preterm Neonates
• Interventions: Device: polyethylene bag

• Registration Number: NCT02798926
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Status Verified: 2016-06
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-09
• Last Update Submitted: 2016-06-09
• Study First Posted: 2016-06-14
• Last Update Posted: 2016-06-14
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with the use of a polyethylene bag	polyethylene bag	-

Primary Outcome Measures

Name	Time	Method
Temperature	1 hour	difference between the prehepatic temperature at the beginning of catheter placement and the lowest temperature observed during the procedure

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France