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

ISRCTN ISRCTN85045728
DOI https://doi.org/10.1186/ISRCTN85045728
ClinicalTrials.gov number NCT00607464
Secondary identifying numbers MCT-71137
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

Study designMulticentre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleMulticentre randomised controlled trial of HELP (heat loss prevention) in the delivery room
Study acronymHeLP
Study objectivesDoes 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) studiedHypothermia in premature infants
InterventionExperimental 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 typeOther
Primary outcome measureDeath to discharge or at six months corrected gestational age
Secondary outcome measures1. 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 study start date01/09/2004
Completion date31/10/2008

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants1685
Key inclusion criteriaInfants 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 criteria1. 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 enrolment01/09/2004
Date of final enrolment31/10/2008

Locations

Countries of recruitment

  • Canada

Study participating centre

University of Alberta
Edmonton
T6G 2R7
Canada

Sponsor information

University of Alberta and Sunnybrook and Women's College Health Sciences Centre (Canada) and The Vermont Oxford Network (USA)
University/education

University of Alberta
222 Campus Tower
8625 - 112 Street NW
Edmonton
T6G 2E1
Canada

ROR logo "ROR" https://ror.org/03wefcv03

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-71137)

No information available

Stollery Children's Hospital Foundation, Edmonton, Alberta (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

07/02/2019: Publication reference added.