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Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room (HeLP)

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ClinicalTrials.gov Identifier: NCT00607464
Recruitment Status : Terminated
First Posted : February 5, 2008
Last Update Posted : April 25, 2016
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Vermont Oxford Network
University of Alberta
Information provided by (Responsible Party):
Maureen Reilly, Sunnybrook Health Sciences Centre

Study Description
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Brief 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)?

Condition or disease Intervention/treatment Phase
Hypothermia in Premature Infants Device: Polyethylene occlusive skin wrap Not Applicable

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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Polyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment
 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
No Intervention: 2
Standard care


Outcome Measures
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Primary Outcome Measures :
  1. Death to discharge or at six months corrected gestational age [ Time Frame: discharge or six months corrected gestational age ]

Secondary Outcome Measures :
  1. 1. Axillary temperature upon arrival in Neonatal Intensive Care Unit (NICU) [ Time Frame: upon arrival in NICU ]
  2. acidosis, hypotension, hypoglycaemia, seizures [ Time Frame: first 12 hours of life ]
  3. 4. Death and neurosensory disability measured at 18 months corrected gestational age [ Time Frame: 18 months corrected gestational age ]
  4. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Vermont Oxford Network
University of Alberta
Investigators
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Principal Investigator: Maureen C Reilly, RRT Sunnybrook Health Sciences Centre
Principal Investigator: Sunita Vohra, MD FRCPC MSc University of Alberta/Stollery Children's Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Maureen Reilly, Sunnybrook Health Sciences Centre:
Hypothermia, premature infants, Polyethylene occlusive wrap
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms