Condition category
Neonatal Diseases
Date applied
09/09/2005
Date assigned
09/09/2005
Last edited
20/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Organisation

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

Sponsor details

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

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes