Erythropoietin, magnesium sulfate and hypothermia for hypoxic-ischemic encephalopathy

Phase 1

Completed

• Conditions: eonatal hypoxic-ischemic encephalopathy; Neonatal Diseases; Hypoxic ischaemic encephalopathy of newborn

• Registration Number: ISRCTN33604417
• Lead Sponsor: Osaka City General Hospital

Brief Summary

2019 results in: https://doi.org/10.1186/s12887-018-1389-z

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-12-31
• Study Start: 2018-09-14
• Last Update Posted: 29 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Neonates admitted to the Osaka City General Hospital Neonatal Intensive Care Unit (NICU) and diagnosed with HIE, meeting institutional criteria for therapeutic hypothermia

Exclusion Criteria

1. Infants older than 6 hours of birth at the time of initiation of hypothermia therapy
2. Infants with major congenital abnormalities
3. Infants with severe growth restriction with birth weight less than 1800 g
4. Infants who were considered critically ill and unlikely to bene?t from neonatal intensive care by the attending neonatologist

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality and morbidity in neonatal period, measured by clinical records regarding in-hospital death, establishment of oral feeding, establishment of spontaneous respiration and brain MRI findings at 1 month of age

Secondary Outcome Measures

Name	Time	Method
eurodevelopmental outcome measured using the Kyoto Scale of Psychological Development (KSPD) at 18 months of age