Randomized, parallel-group comparative study of JR-031 in infants with neonatal hypoxic ischemic encephalopathy (hereinafter referred to as nHIE) for which hypothermia therapy is indicated

Phase 1

Completed

• Conditions: infants with neonatal hypoxic ischemic encephalopathy (nHIE)

• Registration Number: JPRN-jRCT1080224818
• Lead Sponsor: JCR Pharmaceuticals Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1) An infant diagnosed with nHIE and receiving hypothermia therapy
2) An infant whose parent (legal representative) provides written informed consent

Exclusion Criteria

1) An infant with congenital anomaly (e.g., autosomal chromosome anomaly, congenital heart disease, congenital malformation syndrome)
2) An infant with severe intracranial hemorrhage as detected by cranial ultrasonography or CT
3) An infant with severe infection (e.g., sepsis)
4) An infant with hyperkalemia
5) An infant whose parent has a history of serious drug allergy or hypersensitivity
6) An infant whose mother was treated with another investigational drug or product within 10 months before delivery of the infant
7) An infant whose mother was found to be positive for HBs antigen, HCV antibody, or HIV antibody or be serologically positive for syphilis during pregnancy
8) An infant who, in the opinion of the investigator or subinvestigator, is not appropriate for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>Kyoto Scale of Psychological Development 2001

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>1) Developmental assessment (Kyoto Scale of Psychological Development 2001, Bayley Scales of Infant and Toddler Development Third Edition) <br>2) Assessment of abnormality on brain MRI scans<br>3) Gross Motor Function Classification System<br>4) Assessment of Thompson score<br>5) Presence or absence of epileptic seizure<br>6) Presence or absence of gastrostomy<br>7) Presence or absence of ventilation with tracheostomy<br>8) Presence or absence of use of inotropes<br>9) Number of days on artificial ventilation<br>10) General condition