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
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 |
|---|---|
| svohra@cha.ab.ca |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/09/2004 |
| Completion date | 31/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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
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/education
University of Alberta
222 Campus Tower
8625 - 112 Street NW
Edmonton
T6G 2E1
Canada
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
