Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room

Hypothermia in Premature Infants Clinical Trial

— HeLP  

Official title:

Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00607464
• Other study ID #: MCT-71137
• Secondary ID: ISRCTN85045728
• Status: Terminated
• Phase: N/A
• First received: January 22, 2008
• Last updated: August 11, 2011
• Start date: September 2004
• Est. completion date: October 2012

Study information

• Verified date: August 2011
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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)?

Description:

Thermoregulation is a major problem for low birth weight infants. The EPICure study showed that 36% of infants born between 24 and 25 weeks gestation had an admission temperature less than 35 degrees Celsius. Hypothermia is associated with increased risk of morbidity and mortality. The HeLP trial hopes to address these issues with the use of a polyethylene occlusive wrap applied immediately after delivery to infants born at less that 28 weeks gestation. Forty-five centers are currently involved in this study. Infant enrollments began in December 2004.

Primary outcome: To determine if polyethylene occlusive wrap applied immediately after delivery to infants born between 24+0 and 27+6 weeks gestation results in decreased mortality compared with the conventional method of drying. Because of increased mortality and variable center specific resuscitation practices, infants born at less than 24 weeks gestation will be randomized as part of a separate Pilot Study and centers may choose if they wish to participate in this group or not. Secondary outcome: The key secondary outcome will be axillary temperature taken on introduction into a warm environment in the NICU. We will also record clinically important variables including: acidosis, hypotension, hypoglycaemia, seizures, patent ductus arteriosus, respiratory distress syndrome/chronic lung disease, necrotizing enterocolitis and head ultrasound results. Length of stay and cause of death at discharge will also be recorded. Long-term follow-up is critical to our understanding of the implications of any new intervention. As such, we ask parents from hospitals who agree to participate in the follow-up study for permission to contact them approximately 18 months after birth.

Preterm infants meeting the eligibility criteria will be randomly assigned within three gestational age strata (less than 24 weeks, 24+0 to 25+6 weeks gestation, and 26+0 to 27+6 weeks gestation) to either the occlusive skin wrap group or the standard of care (non-wrap) group.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1685
• Est. completion date: October 2012
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 28 Weeks

Eligibility

Inclusion Criteria:Infants born at less than 28 weeks and who have prior to birth a firm decision to provide full resuscitative measures and intensive support.

Exclusion Criteria:1. Infants born with major congenital anomalies that are not covered by skin (e.g. gastroschisis, meningomyelocele) 2. Infants born with blistering skin conditions that preclude the use of occlusive wrap

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia in Premature Infants

Intervention

Device:
• Polyethylene occlusive skin wrap
Polyethylene occlusive skin wrap applied immediately after birth and removed after the infant has been admitted to a stable thermoneutral environment

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR), University of Alberta, Vermont Oxford Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death to discharge or at six months corrected gestational age		discharge or six months corrected gestational age	No
Secondary	1. Axillary temperature upon arrival in Neonatal Intensive Care Unit (NICU)		upon arrival in NICU	No
Secondary	acidosis, hypotension, hypoglycaemia, seizures		first 12 hours of life	No
Secondary	4. Death and neurosensory disability measured at 18 months corrected gestational age		18 months corrected gestational age	No
Secondary	PDA, RDS, CLD, pneumothorax, sepsis, IVH, PVL, NEC, GI perforation, pulmonary hemorrhage, hearing, ROP		discharge from hospital or 6 months corrected gestational age	No

External Links

•   The Vermont Oxford Network