Erythropoietin and darbepoetin treatment to reduce brain injury after birth asphyxia

Not Applicable

• Conditions: eonatal encephalopathy; Neonatal Diseases; Neonatal encephalopathy

• Registration Number: ISRCTN13423963
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-20
• Last Update Posted: 16 October 2023
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Study 1: Healthy adult volunteers

Study 2: Babies (> 36-week gestation and birthweight > 1.8 kg) requiring resuscitation at birth with evidence of acute perinatal asphyxia (metabolic acidosis in cord and/or blood gas (pH< 7.15; BE > -12) within 1h of birth; acute obstetric event) AND the need for continued resuscitation or ventilation at 10 minutes and a 10 min Apgar score < 6 AND evidence of moderate or severe HIE on an NICHD neurological examination performed between 1 and 6h of birth AND cooling was initiated before 6 h of age.

Exclusion Criteria

Study 1:
1. Adults with disease
2. Adults with metal implant fitted, such as a pacemaker or artificial joint
3. Pregnant adults

Study 2:
1. Babies with lethal congenital malformations
2. Concomitant participation in other research projects
3. Lack of parental consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean (SD) of thalamic NAA level in babies treated with Epo and Darbe when compared with untreated infants, measured using magnetic resonance spectroscopy between 1 and 2 weeks after birth

Secondary Outcome Measures

Name	Time	Method
umber of babies in whom thalamic NAA level could be accurately quantified in magnetic resonance spectroscopy in 3 Tesla and 1.5 Tesla MR scanners, measured between 1 and 2 weeks after birth