Pilot study to explore additional indication of therapeutic hypothermia for neonates

Not Applicable

• Conditions: eonatal encephalopathy

• Registration Number: JPRN-UMIN000035536
• Lead Sponsor: Kurume University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-12-01
• Study Start: 2019-01-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Gestational age <33 weeks or body weight <1500g. Older than 12 hours of birth. Neonates deemed inappropriate for cooling because of critical clinical conditions, such as severe haemorrhagic diathesis, congenital malformations, infection and cardiopulmonary failure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death or severe adverse events until hospital discharge

Secondary Outcome Measures

Name	Time	Method
Days on mechanical ventilation Age at hospital discharge Requirement for tube-feeding at discharge Death or moderate disability (Time Frame: Birth to 18-22 months corrected age) Brain MRI findings (Time Frame: 5-14 days)