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

NCT02798926 | Unknown

• 1 other identifier: AOL09-DR-GHYSELEN
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Neonates

Keywords

hypothermia; central venous catheter placement; Polyethylene bag

Outcome Measures

Primary Outcomes (1)

• Temperature

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

  1 hour

Study Arms (2)

with the use of a polyethylene bag

Device: polyethylene bag

without the use of a polyethylene bag

Interventions

polyethylene bag DEVICE

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

with the use of a polyethylene bag

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• premature Newborn child = 32 weeks of gestational age
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent GHYSELEN, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent GHYSELEN, PhD

CONTACT

+33 3 22 08 76 13; ghyselen.laurent@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

FR (1)