Contact information
Type
Scientific
Primary contact
Dr Sunita Vohra
ORCID ID
Contact details
University of Alberta
Dept. of Pediatrics
2C3 Walter MacKenzie Health Science Centre
8440 112 Street
Edmonton
T6G 2R7
Canada
+1 780-407-3798
svohra@cha.ab.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00607464
Protocol/serial number
MCT-71137
Study information
Scientific title
Acronym
HeLP
Study hypothesis
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)?
Ethics approval
University of Alberta Health Research Ethics Board (July 2004) & The Research Ethics Board of Sunnybrook & Women's College Health Sciences Centre (July 2004)
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Hypothermia in premature infants
Intervention
Experimental arm: Polyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment
Control arm: standard care
For further information please contact Dr Vohra at the address listed below or Ms Maureen Reilly, RRT at Sunnybrook and Women's College Health Sciences Centre (maureen.reilly@sw.ca).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Death to discharge or at six months corrected gestational age
Secondary outcome measures
1. Axillary temperature upon arrival in Neonatal Intensive Care Unit (NICU)
2. Apgar scores, incidence of acidosis, hypotension, hypoglycaemia, seizures in the first 12 hours of life
3. Patent ductus arteriosus, respiratory distress, syndrome/chronic lung disease, necrotizing enterocolitis/GI perforation, Retinopathy of Prematurity, sepsis, hearing, pneumothorax, intraventricular Haemorrhage/periventricular leukomalacia, pulmonary hemorrhage all measured at 36 weeks corrected gestational age, or at time of death or discharge home
4. Death and neurosensory disability measured at 18 months corrected gestational age
Overall trial start date
01/09/2004
Overall trial end date
31/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Infants born at less than 28 weeks (aged 0 - 27 days, either sex) whose delivery is considered imminent and have consented (written) to participate in the trial. Prior to birth a firm decision to provide full resuscitative measures and intensive support must be made.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
1685
Participant exclusion criteria
1. Infants born with major congenital anomalies that are not covered by skin (e.g. gastroschisis, meningomyelocele)
2. Infants whose deliveries are not attended by the neonatal team (e.g. precipitous delivery on route to the labour suite)
3. Infants born with blistering skin conditions that preclude the use of occlusive wrap
Recruitment start date
01/09/2004
Recruitment end date
31/10/2008
Locations
Countries of recruitment
Canada
Trial participating centre
University of Alberta
Edmonton
T6G 2R7
Canada
Sponsor information
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-71137)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Stollery Children's Hospital Foundation, Edmonton, Alberta (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary