Clinical trial NCT02798926: Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?
Official title: Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Neonates
Keywords: hypothermia
central venous catheter placement
Polyethylene bag
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 60
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: preterm neonates less than 32 weeks of gestational age (WGA)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Temperature
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Laurent GHYSELEN, PhD
role: PRINCIPAL_INVESTIGATOR
References: