An extension study of JR-031 in infants with neonatal hypoxic ischemic encephalopathy (hereinafter referred to as nHIE) for which hypothermia therapy is indicated

JRCT ID: jRCT2033200293

Registered date:13/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: neonatal hypoxic ischemic encephalopathy (nHIE)
• Date of first enrollment: 22/02/2021
• Target sample size: 13
• Study type: Observational
• Intervention(s): None

Outcome(s)

• Primary Outcome: Kyoto Scale of Psychological Development 2001

Key inclusion & exclusion criteria

• Age minimum: > 1age old
• Age maximum: < 2age old
• Gender: Both
• Include criteria: An infant whose parent (legal representative) provides written informed consent
• Exclude criteria: An infant who, in the opinion of the investigator or subinvestigator, is not appropriate for the study

Related Information

• Primary Sponsor: Yamamoto Tatsuyoshi