At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 256 enrolled

Drug / intervention

Cooling cap (YJW608-04B)device

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00890409

NCT00890409Phase 3Completed

Compare CT.gov

Selective Head Cooling With Mild Systemic Hypothermia After Neonatal Hypoxic-Ischemic Encephalopathy: A Multi-Center Randomized Controlled Trial in China

Fudan University·interventional·Posted Apr 29, 2009·Updated May 28, 2009

In Brief

A Phase 3 clinical trial evaluating Cooling cap (YJW608-04B) for Hypoxic-Ischemic Encephalopathy. Completed, enrolled 256 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHypoxic-Ischemic Encephalopathy

CountriesChina

CollaboratorsQingdao Children's Hospital, Guangxi Maternity and Infant health Hospital, Quanzhou Children's Hospital, The Second Hospital of Nanjing Medical University

Timeline

Phase 3CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2002

Primary CompletionJun 2004

Study CompletionAug 2005

First PostedApr 2009

TodayJul 2026

First PostedApr 29, 2009

Enrollment StartMay 1, 2002

Primary CompletionJun 1, 2004

Study CompletionAug 1, 2005

TodayJul 2, 2026

Enrollment to primary: 2.1 yearsPosted 17.2 years ago

Interventions

Cooling cap (YJW608-04B)device

A semiconductor water circulation cooling device (YJW608-04B, Henyang Radio Manufactory, Hunan, China) was used to conduct head cooling. The hypothermia group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C. All infants were nursed under a servo-controlled radiant warmer and the rectal temperature was maintained at 34.5 to 35 degree C. Head cooling was started within 6 hours after birth for 72 hours followed by spontaneous re-warming and the average time to reach the target temperature was 2 hours.