Hypothermia in Premature Infants Clinical Trial
Official title:
Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room
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)?
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment