Hypothermia in Premature InfantsHeLPNCT00607464
Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room
A study testing Polyethylene occlusive skin wrap in people with Hypothermia in Premature Infants, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Does polyethylene occlusive wrap applied immediately after delivery to infants born at less than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the standard of care as determined by the Neonatal Resuscitation Program guidelines (i.e. drying under radiant heat)? Read more about this study
- Who is it for?
- Ages 24 to 28 weeks
- Conditions the study is for
- Hypothermia in Premature Infants
- What is being tested?
- Polyethylene occlusive skin wrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Oct 2012
- Phase
- Interventional
- 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 24 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria:Infants born at less than 28 weeks and who have prior to birth a firm decision to provide full resuscitative measures and intensive support.
-
Exclusion Criteria:1. Infants born with major congenital anomalies that are not covered by skin (e.g. gastroschisis, meningomyelocele) 2. Infants born with blistering skin conditions that preclude the use of occlusive wrap
-
Trial locations and contacts
1 site in 1 country.
About this study
Does polyethylene occlusive wrap applied immediately after delivery to infants born at less than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the standard of care as determined by the Neonatal Resuscitation Program guidelines (i.e. drying under radiant heat)?
Read the detailed description
Thermoregulation is a major problem for low birth weight infants. The EPICure study showed that 36% of infants born between 24 and 25 weeks gestation had an admission temperature less than 35 degrees Celsius. Hypothermia is associated with increased risk of morbidity and mortality. The HeLP trial hopes to address these issues with the use of a polyethylene occlusive wrap applied immediately after delivery to infants born at less that 28 weeks gestation. Forty-five centers are currently involved in this study. Infant enrollments began in December 2004.
Primary outcome: To determine if polyethylene occlusive wrap applied immediately after delivery to infants born between 24+0 and 27+6 weeks gestation results in decreased mortality compared with the conventional method of drying. Because of increased mortality and variable center specific resuscitation practices, infants born at less than 24 weeks gestation will be randomized as part of a separate Pilot Study and centers may choose if they wish to participate in this group or not. Secondary outcome: The key secondary outcome will be axillary temperature taken on introduction into a warm environment in the NICU. We will also record clinically important variables including: acidosis, hypotension, hypoglycaemia, seizures, patent ductus arteriosus, respiratory distress syndrome/chronic lung disease, necrotizing enterocolitis and head ultrasound results. Length of stay and cause of death at discharge will also be recorded. Long-term follow-up is critical to our understanding of the implications of any new intervention. As such, we ask parents from hospitals who agree to participate in the follow-up study for permission to contact them approximately 18 months after birth.
Preterm infants meeting the eligibility criteria will be randomly assigned within three gestational age strata (less than 24 weeks, 24+0 to 25+6 weeks gestation, and 26+0 to 27+6 weeks gestation) to either the occlusive skin wrap group or the standard of care (non-wrap) group.
- Conditions
- Hypothermia in Premature Infants
- Being tested
- Polyethylene occlusive skin wrap
- Keywords
- Hypothermia, premature infants, Polyethylene occlusive wrap
- Medical subject headings
- Hypothermia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene occlusive skin wrapDevice
Also called occlusive skin wrap
Polyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Polyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment Receives: Device: Polyethylene occlusive skin wrap |
| 2 | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death to discharge or at six months corrected gestational age
Measured: discharge or six months corrected gestational age
Secondary outcomes (4)
1. Axillary temperature upon arrival in Neonatal Intensive Care Unit (NICU)
Measured: upon arrival in NICU
acidosis, hypotension, hypoglycaemia, seizures
Measured: first 12 hours of life
4. Death and neurosensory disability measured at 18 months corrected gestational age
Measured: 18 months corrected gestational age
PDA, RDS, CLD, pneumothorax, sepsis, IVH, PVL, NEC, GI perforation, pulmonary hemorrhage, hearing, ROP
Measured: discharge from hospital or 6 months corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startSep 2004
- Primary completionMar 2010
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypothermia in Premature InfantsStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Vermont Oxford Network, University of Alberta
- Responsible party
- Principal investigator, Maureen Reilly, Sunnybrook Health Sciences Centre
- Investigators
- Maureen C Reilly, RRT, Principal investigator, Sunnybrook Health Sciences CentreSunita Vohra, MD FRCPC MSc, Principal investigator, University of Alberta/Stollery Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607464
- Sponsor's protocol ID
- MCT-71137
- Other IDs
- ISRCTN85045728
- Acronym
- HeLP
- Status last verified
- Apr 2016
- First submitted
- 22 Jan 2008
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vincer MJ, Reilly MC, Vohra S, Rac VE, Bhaloo Z, Dunn M, Ferrelli K, Kiss A, Wimmer J, Zayack D, Soll R; Vermont Oxford Network HeLP Trial Study Group. Randomized trial of occlusive wrap for heat loss prevention in preterm infants: neurodevelopmental outcome. BMC Pediatr. 2026 Aug 8;26(1):781. doi: 10.1186/s12887-025-05678-6.
PubMed 42638093Reilly MC, Vohra S, Rac VE, Dunn M, Ferrelli K, Kiss A, Vincer M, Wimmer J, Zayack D, Soll RF; Vermont Oxford Network Heat Loss Prevention (HeLP) Trial Study Group. Randomized trial of occlusive wrap for heat loss prevention in preterm infants. J Pediatr. 2015 Feb;166(2):262-8.e2. doi: 10.1016/j.jpeds.2014.09.068. Epub 2014 Nov 12.
PubMed 25449224Vohra S, Reilly M, Rac VE, Bhaloo Z, Zayack D, Wimmer J, Vincer M, Ferrelli K, Kiss A, Soll R, Dunn M. Study protocol for multicentre randomized controlled trial of HeLP (Heat Loss Prevention) in the delivery room. Contemp Clin Trials. 2013 Sep;36(1):54-60. doi: 10.1016/j.cct.2013.06.001. Epub 2013 Jun 11.
PubMed 23770234
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room
- ClinicalTrials.gov ID
- NCT00607464
- Acronym / sponsor ID
- HeLP / MCT-71137
- Conditions
- Hypothermia in Premature Infants
- Keywords
- Hypothermia, premature infants, Polyethylene occlusive wrap
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Vermont Oxford Network, University of Alberta
- Study start
- Sep 2004
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Feb 2008 (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.
Does polyethylene occlusive wrap applied immediately after delivery to infants born at less than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the standard of care as determined by the Neonatal Resuscitation Program guidelines (i.e. drying under radiant heat)?
Detailed description
Thermoregulation is a major problem for low birth weight infants. The EPICure study showed that 36% of infants born between 24 and 25 weeks gestation had an admission temperature less than 35 degrees Celsius. Hypothermia is associated with increased risk of morbidity and mortality. The HeLP trial hopes to address these issues with the use of a polyethylene occlusive wrap applied immediately after delivery to infants born at less that 28 weeks gestation. Forty-five centers are currently involved in this study. Infant enrollments began in December 2004.
Primary outcome: To determine if polyethylene occlusive wrap applied immediately after delivery to infants born between 24+0 and 27+6 weeks gestation results in decreased mortality compared with the conventional method of drying. Because of increased mortality and variable center specific resuscitation practices, infants born at less than 24 weeks gestation will be randomized as part of a separate Pilot Study and centers may choose if they wish to participate in this group or not. Secondary outcome: The key secondary outcome will be axillary temperature taken on introduction into a warm environment in the NICU. We will also record clinically important variables including: acidosis, hypotension, hypoglycaemia, seizures, patent ductus arteriosus, respiratory distress syndrome/chronic lung disease, necrotizing enterocolitis and head ultrasound results. Length of stay and cause of death at discharge will also be recorded. Long-term follow-up is critical to our understanding of the implications of any new intervention. As such, we ask parents from hospitals who agree to participate in the follow-up study for permission to contact them approximately 18 months after birth.
Preterm infants meeting the eligibility criteria will be randomly assigned within three gestational age strata (less than 24 weeks, 24+0 to 25+6 weeks gestation, and 26+0 to 27+6 weeks gestation) to either the occlusive skin wrap group or the standard of care (non-wrap) group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Polyethylene occlusive skin wrapPolyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment |
| 2 | No intervention | –Standard care |
Who may qualify
- Ages
- 24 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 occlusive skin wrapAlso: occlusive skin wrapPolyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment | Device | 1 |
Primary outcome
Death to discharge or at six months corrected gestational age
Time frame: discharge or six months corrected gestational age
4 secondary outcomes
1. Axillary temperature upon arrival in Neonatal Intensive Care Unit (NICU)
Time frame: upon arrival in NICU
acidosis, hypotension, hypoglycaemia, seizures
Time frame: first 12 hours of life
4. Death and neurosensory disability measured at 18 months corrected gestational age
Time frame: 18 months corrected gestational age
PDA, RDS, CLD, pneumothorax, sepsis, IVH, PVL, NEC, GI perforation, pulmonary hemorrhage, hearing, ROP
Time frame: discharge from hospital or 6 months corrected gestational age
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Derived from this study: PubMed 42638093Vincer MJ, Reilly MC, Vohra S, Rac VE, Bhaloo Z, Dunn M, Ferrelli K, Kiss A, Wimmer J, Zayack D, Soll R; Vermont Oxford Network HeLP Trial Study Group. Randomized trial of occlusive wrap for heat loss prevention in preterm infants: neurodevelopmental outcome. BMC Pediatr. 2026 Aug 8;26(1):781. doi: 10.1186/s12887-025-05678-6.
- Derived from this study: PubMed 25449224Reilly MC, Vohra S, Rac VE, Dunn M, Ferrelli K, Kiss A, Vincer M, Wimmer J, Zayack D, Soll RF; Vermont Oxford Network Heat Loss Prevention (HeLP) Trial Study Group. Randomized trial of occlusive wrap for heat loss prevention in preterm infants. J Pediatr. 2015 Feb;166(2):262-8.e2. doi: 10.1016/j.jpeds.2014.09.068. Epub 2014 Nov 12.
- Derived from this study: PubMed 23770234Vohra S, Reilly M, Rac VE, Bhaloo Z, Zayack D, Wimmer J, Vincer M, Ferrelli K, Kiss A, Soll R, Dunn M. Study protocol for multicentre randomized controlled trial of HeLP (Heat Loss Prevention) in the delivery room. Contemp Clin Trials. 2013 Sep;36(1):54-60. doi: 10.1016/j.cct.2013.06.001. Epub 2013 Jun 11.
- The Vermont Oxford NetworkLink provided by the sponsor.
Related trials for Hypothermia in Premature Infants
Active, not recruitingObservational study
Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
Neonatal Encephalopathy
RecruitingObservational study
Cerebral/ Cortical Visual Impairment: Screening, Identification and Outcome Prediction in Neonates
Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
RecruitingObservational study
Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
Neonatal Hypothermia, Brown Adipose Tissue
Recruiting
Blood Warming in Preterm Infants to Decrease Hypothermia
Preterm Birth, Blood Transfusion Complication
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.
Maureen C Reilly, RRT principal investigator
Sunnybrook Health Sciences Centre
Sunita Vohra, MD FRCPC MSc principal investigator
University of Alberta/Stollery Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene occlusive skin wrap in people with Hypothermia in Premature Infants, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 25 Apr 2016. 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 Canada. 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 was stopped early. Results are not available in the source record.
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?
Death to discharge or at six months corrected gestational age (time frame: discharge or six months corrected gestational age). 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 NCT00607464, which also lists 3 linked publications.
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 25 Apr 2016.