PAEAN – Erythropoietin for hypoxic ischaemic encephalopathy in newborns

Phase 3

Active, not recruiting

• Conditions: neonatal hypoxic ischaemic encephalopathy; Reproductive Health and Childbirth - Complications of newborn; Neurological - Other neurological disorders

• Registration Number: ACTRN12614000669695
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-25
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

1.Male or female infants born greater than or equal to 35+0 weeks gestation and able to be randomised less than 23 hours after birth.

2.One or more of the following indications of perinatal depression:
a. Apgar less than or equal to 5 at 10 minutes after birth OR
b. receiving ongoing resuscitation eg assisted ventilation (positive pressure ventilation or CPAP) or chest compressions at 10 minutes after birth OR
c. on cord blood or arterial or venous blood obtained at less 60 minutes after birth the following values: pH less than 7.00 ORbase deficit greater than or equal to 12

3.Moderate to severe encephalopathy, defined between one and six hours after birth by one or both of the following
a. 3 out of 6 modified Sarnat criteria indicating moderate/severe encephalopathy
OR
b. 2 out of 6 modified Sarnat criteria plus seizure(s) requiring anticonvulsant treatment (diagnosed either clinically or using EEG monitoring)

4.Hypothermia treatment initiated by 6 hours of age; i.e. controlled whole-body cooling for 72 hours, to a target temperature (adjusted manually or with a device) and subsequent controlled re-warming

5.Study treatment both planned and able to start within 24 hours after birth (as soon as feasible after randomisation)

6.One parent greater than or equal to 18 years of age

7.Anticipated ability to collect primary endpoint at 2 years of age

8.Signed, written informed parental consent

Exclusion Criteria

1. Contraindications to investigational product

2. Indication prior to randomisation for erythropoietin or any other erythropoietic stimulating agent to be given during the first two weeks of life.

3. Severe intrauterine growth restriction (birth weight less than 1800g)

4. Suspected major chromosomal or congenital anomalies

5. Head circumference less than 3rd centile below the mean for gestation and gender.

6. Infant for whom imminent withdrawal of care is being planned.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare composite of death or moderate/severe disability in infants treated with either erythropoietin or control group (placebo) using death and disability assessments such as paediatric review (Any CP), GMFCS score (greater than or equal to 2) and Bayley Scale of Infant Development III (2 or more stand deviations below the mean)[2 years of age]

Secondary Outcome Measures

Name	Time	Method
Death (at any time from day 1 of treatment to 2 years of age)[2 years];Cerebral palsy assessed by paediatric assessment[2 years of age];Moderate-severe motor deficit is defined as any incident of cerebral palsy (any of quadriplegia (QP); triplegia; hemiplegia (HP), diplegia (DP) or monoplegia) plus any level of functional impairment using the Gross Motor Function Classification Scale (GMFCS) greater than or equal to 2.0.<br>[2 years of age];Cognitive deficit (Bayley III Cognitive Score)[2 years of age];Need for supplementary respiratory or nutritional support [2 years of age];Cortical visual impairment by paediatric exam[2 years of age];Hearing impairment by paediatric exam[2 years of age];Removal of secondary outcome [8]. [Removal of secondary outcome [8].];Epilepsy by paediatric exam[2 years of age];Cost of healthcare and service utilisation by parent completed questionnaire and Medicare service use[2 years of age]