Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room (HeLP)
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| ClinicalTrials.gov Identifier: NCT00607464 |
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Recruitment Status :
Terminated
First Posted : February 5, 2008
Last Update Posted : April 25, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypothermia in Premature Infants | Device: Polyethylene occlusive skin wrap | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 804 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | March 2010 |
| Actual Study Completion Date : | October 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Polyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment
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Device: Polyethylene occlusive skin wrap
Polyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment
Other Name: occlusive skin wrap |
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No Intervention: 2
Standard care
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- Death to discharge or at six months corrected gestational age [ Time Frame: discharge or six months corrected gestational age ]
- 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 ]
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| Ages Eligible for Study: | 24 Weeks to 28 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607464
| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Principal Investigator: | Maureen C Reilly, RRT | Sunnybrook Health Sciences Centre | |
| Principal Investigator: | Sunita Vohra, MD FRCPC MSc | University of Alberta/Stollery Children's Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Maureen Reilly, RRT, Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT00607464 |
| Other Study ID Numbers: |
MCT-71137 ISRCTN85045728 |
| First Posted: | February 5, 2008 Key Record Dates |
| Last Update Posted: | April 25, 2016 |
| Last Verified: | April 2016 |
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Hypothermia, premature infants, Polyethylene occlusive wrap |
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Hypothermia Body Temperature Changes |