HypothermiaNCT00603837

Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.

A study testing NeoWrap and InfaTherm in people with Hypothermia, run by University of Oklahoma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming blankets. Read more about this study

Who is it for?: Ages 24 to 28 weeksHealthy volunteers can take part
Conditions the study is for: Hypothermia
What is being tested?: NeoWrap and InfaTherm
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: May 2007to Nov 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 24 to 28 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Participants in this study will be selected from the inborn population at University Hospital. Eligible patients will be selected from the group of babies with estimated gestational ages of 24-28 weeks and <1250g.

Who cannot join

Congenital anomalies with open lesions such as meningomyelocele, or omphaloceles
Blistering skin conditions
Resuscitation not performed secondary to infant being below limits of viability as assessed by the in-house attending physician (specifically, according to current NRP recommendations):
Where gestation, birth weight, and/or congenital anomalies are associated with almost certain early death, and unacceptably high morbidity is likely among the rare survivors, resuscitation is not indicated. Exceptions may be made based on parental desires.
Newborns with confirmed gestation age of less than 24 weeks or birth weight less than 400 grams
Anencephaly

Show all 10Show fewer

Confirmed Trisomy 13 or Trisomy 18 syndrome
Meconium staining of amniotic fluid
Birth assessment of gestational age > 28 weeks or >1250 grams
Maternal temp >38 degrees C around the time of delivery.

Trial locations and contacts

1 site in 1 country.

United States1 site

Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: Thermal Defense of Extremely Low Gestational Age Newborns (ELGANs) During Resuscitation: Exothermic Mattresses vs. Polyethylene Wrap

Conditions: Hypothermia
Being tested: NeoWrap, InfaTherm
Keywords: Hypothermia, Prevention, ELGANs(Extremely low gestational age neonates), Polyethylene Wrap, Sodium Acetate Transport Mattress
Medical subject headings: Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NeoWrapDevice
This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.
InfaThermDevice
A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.

Study groups in NCT00603837
Study group	Role	What they receive
Blanket	Experimental	This arm includes those Extremely low gestational age newborns (ELGANs) who are to be placed on a sodium acetate warming blanket after delivery. Receives: Device: InfaTherm
Wrap	Experimental	This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery. Receives: Device: NeoWrap

What is being measured

The primary outcome is the main question the study is designed to answer.

Neonatal Intensive Care Unit (NICU) Admission Temperature
Axillary temperature of the infant upon arrival to the neonatal intensive care unit.
Measured: At time of admission to the NICU - usually within 10-15 min of birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Nov 2008

First posted29 Jan 2008 (estimated)
Study startMay 2007
Primary completionNov 2008
Study completionNov 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypothermiaStudies of the same condition, open and under way.
More trials run by University of OklahomaThe 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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00603837
Sponsor's protocol ID: 13223
Status last verified: Oct 2009
First submitted: 19 Dec 2007
Last updated: 16 Oct 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypothermia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Thermal Defense of Extremely Low Gestational Age Newborns (ELGANs) During Resuscitation: Exothermic Mattresses vs. Polyethylene Wrap
ClinicalTrials.gov ID: NCT00603837
Acronym / sponsor ID: 13223
Conditions: Hypothermia
Keywords: Hypothermia, Prevention, ELGANs(Extremely low gestational age neonates), Polyethylene Wrap, Sodium Acetate Transport Mattress
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: University of OklahomaUniversity, hospital or other
Study start: May 2007
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 29 Jan 2008 (estimated)
Results: Posted 2 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Blanket	Experimental	Device: InfaThermThis arm includes those Extremely low gestational age newborns (ELGANs) who are to be placed on a sodium acetate warming blanket after delivery.
Wrap	Experimental	Device: NeoWrapThis arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.

Who may qualify

Ages: 24 to 28 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Participants in this study will be selected from the inborn population at University Hospital. Eligible patients will be selected from the group of babies with estimated gestational ages of 24-28 weeks and <1250g.

Key exclusion criteria (10 listed)

Congenital anomalies with open lesions such as meningomyelocele, or omphaloceles
Blistering skin conditions
Resuscitation not performed secondary to infant being below limits of viability as assessed by the in-house attending physician (specifically, according to current NRP recommendations):

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
NeoWrapThis is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.	Device	Wrap
InfaThermA gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.	Device	Blanket

Primary outcome

Neonatal Intensive Care Unit (NICU) Admission Temperature
Time frame: At time of admission to the NICU - usually within 10-15 min of birth
Axillary temperature of the infant upon arrival to the neonatal intensive care unit.

Results and safety

Results posted to the registry on 2 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Blanket	20	17
Wrap	19	19

Primary outcome: Neonatal Intensive Care Unit (NICU) Admission Temperature

Time frame: At time of admission to the NICU - usually within 10-15 min of birth. Mean (Standard Deviation). Unit: Celsius degrees

Measure	Blanket n = 17	Wrap n = 19
Value	36.5 (0.67)	36.1 (0.66)

Blanket vs Wrap: p = 0.445, t-test, 1 sided

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Blanket	0 of 0	0 of 0	Not reported
Wrap	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Technical difficulties with the polyethylene wrap were the main limitations (variation of use, heat loss during pulse oximeter adjustment).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypothermia

Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Not yet recruiting
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Pediatric Liver Transplantation

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.

Douglas Dannaway, MD principal investigator

University of Oklahoma

Parker L Simon, DO, MPH study director

University of Oklahoma

Marilyn Escobedo, MD study chair

University of Oklahoma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NeoWrap and InfaTherm in people with Hypothermia, run by University of Oklahoma at 1 site in United States.

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 1 inclusion and 10 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 16 Oct 2009. 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 United States. 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?

Yes. Results are posted in the registry (first posted 2 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Neonatal Intensive Care Unit (NICU) Admission Temperature (time frame: At time of admission to the NICU - usually within 10-15 min of birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00603837.

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 16 Oct 2009.