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

Preterm Neonates Clinical Trial

— PSac  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02798926
• Other study ID #: AOL09-DR-GHYSELEN
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2016
• Last updated: June 9, 2016
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Laurent GHYSELEN, PhD
• Phone: +33 3 22 08 76 13
• Email: ghyselen.laurent[@]chu-amiens.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypothermia
• Premature Birth
• Preterm Neonates

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature	difference between the prehepatic temperature at the beginning of catheter placement and the lowest temperature observed during the procedure	1 hour	No