Preterm NeonatesPSacNCT02798926
Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?
An observational study of Preterm Neonates, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 0 to 7 days
- Conditions the study is for
- Preterm Neonates
- What is being tested?
- polyethylene bag
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2014to 23 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: preterm neonates less than 32 weeks of gestational age (WGA)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- polyethylene bag
- Keywords
- hypothermia, central venous catheter placement, Polyethylene bag
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene bagDevice
The infant will be wrapped in a polyethylene bag 15 min before starting central venous catheter placement
| Study group | Role | What they receive |
|---|---|---|
| with the use of a polyethylene bag | Not described Receives: Device: polyethylene bag | |
| without the use of a polyethylene bag | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
difference between the prehepatic temperature at the beginning of catheter placement and the lowest temperature observed during the procedure
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start19 Jun 2014
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm NeonatesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent GHYSELEN, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798926
- Sponsor's protocol ID
- AOL09-DR-GHYSELEN
- Acronym
- PSac
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?
- ClinicalTrials.gov ID
- NCT02798926
- Acronym / sponsor ID
- PSac / AOL09-DR-GHYSELEN
- Conditions
- Preterm Neonates
- Keywords
- hypothermia, central venous catheter placement, Polyethylene bag
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 19 Jun 2014 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with the use of a polyethylene bag | – | Device: polyethylene bag |
| without the use of a polyethylene bag | – | – |
Who may qualify
- Ages
- 0 to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- preterm neonates less than 32 weeks of gestational age (WGA)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyethylene bagThe infant will be wrapped in a polyethylene bag 15 min before starting central venous catheter placement | Device | with the use of a polyethylene bag |
Primary outcome
Temperature
Time frame: 1 hour
difference between the prehepatic temperature at the beginning of catheter placement and the lowest temperature observed during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent GHYSELEN, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Neonates, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.