Multicentre randomised controlled trial of HELP (heat loss prevention) in the delivery room

ISRCTN	ISRCTN85045728
DOI	https://doi.org/10.1186/ISRCTN85045728
ClinicalTrials.gov (NCT)	NCT00607464
Protocol serial number	MCT-71137
Sponsor	University of Alberta and Sunnybrook and Women's College Health Sciences Centre (Canada) and The Vermont Oxford Network (USA)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-71137), Stollery Children's Hospital Foundation, Edmonton, Alberta (Canada)

Submission date: 09/09/2005
Registration date: 09/09/2005
Last edited: 07/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sunita Vohra
Scientific

University of Alberta
Dept. of Pediatrics
2C3 Walter MacKenzie Health Science Centre
8440 112 Street
Edmonton
T6G 2R7
Canada

Phone	+1 780-407-3798
Email	svohra@cha.ab.ca

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Multicentre randomised controlled trial of HELP (heat loss prevention) in the delivery room
Study acronym	HeLP
Study objectives	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(s)	University of Alberta Health Research Ethics Board (July 2004) & The Research Ethics Board of Sunnybrook & Women's College Health Sciences Centre (July 2004)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Death to discharge or at six months corrected gestational age
Key secondary outcome measure(s)	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
Completion date	31/10/2008

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	1685
Key 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.
Key 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
Date of first enrolment	01/09/2004
Date of final enrolment	31/10/2008

Locations

Countries of recruitment

Canada

Study participating centre

University of Alberta

Edmonton
T6G 2R7
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2015	07/02/2019	Yes	No
Protocol article	protocol	01/09/2013	07/02/2019	Yes	No

Editorial Notes

07/02/2019: Publication reference added.