Clinical trial NCT00930917: Heat Loss Prevention in Delivery Room Using a Polyethylene Cap
Official title: Heat Loss Prevention in Delivery Room: a Prospective, Randomised, Controlled Trial of Polyethylene Caps in Very Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypothermia, Preterm Infants
Keywords: delivery room, polyethylene cap, preterm infant, temperature
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 96
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: It is apparent that the head of a preterm infant should not be left uncovered, however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss.

We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap prevents postnatal heat loss.

Detailed description: The primary outcome measure was axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later. Axillary temperature was measured using a digital thermometer (Terumo Digital Clinical Thermometer C202, Terumo Corporation, Tokio, Japan). The occurrence of hypothermia, defined as axillary temperature less then 36.4°C, on NICU admission was also evaluated.

Secondary outcomes included mortality prior to hospital discharge, presence of major brain injury (sonographic evidence of intraventricular hemorrhage with ventricular dilatation, parenchymal hemorrhagic infarction, or periventricular leukomalacia), tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.

Eligibility criteria: Inclusion Criteria:

* infants \<29 weeks' gestation born in the study center.

Exclusion Criteria:

* congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team.

Primary outcomes:
measure: Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later.
timeFrame: Admission to the NICU
Secondary outcomes:
measure: Mortality prior to hospital discharge, presence of major brain injury, tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.
timeFrame: NICU discharge
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Ospedaliera of Padua
name: Daniele Trevisanuto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trevisanuto D, Doglioni N, Cavallin F, Parotto M, Micaglio M, Zanardo V. Heat loss prevention in very preterm infants in delivery rooms: a prospective, randomized, controlled trial of polyethylene caps. J Pediatr. 2010 Jun;156(6):914-917.e1. doi: 10.1016/j.jpeds.2009.12.021. Epub 2010 Mar 15.