Hypothermia in premature infants Neonatal Diseases Hypothermia
Conditions
Interventions
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: sta
Sponsors
University of Alberta and Sunnybrook and Women's College Health Sciences Centre (Canada) and The Vermont Oxford Network (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death to discharge or at six months corrected gestational age | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed