Effect of Recombinant Human EPO on Outcome of Encephalopathy Patients

Effect of Recombinant Human EPO on Outcome of Ischemic Hypoxic Encephalopathy Patients Born In Hajar Hospital of Shahrekord, Iran

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013033011470N2

Enrollment

Registered

2013-05-24

Start date

2013-05-09

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic Ischaemic Encephalopathy. Hypoxic Ischaemic Encephalopathy Of Newborn

Interventions

Intervention 1: Control group: standard therapies including hypothermia reduces apoptosis mechanisms. Intervention 2: In the intervention group, in addition to supportive treatment with recombinant hu

Rehabilitation

Treatment - Drugs

Control group: standard therapies including hypothermia reduces apoptosis mechanisms

In the intervention group, in addition to supportive treatment with recombinant human erythropoietin therapy to a dose of 25,000 units per Kg of body weight subcutaneously at 6-4 hours after birth as

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 38 and 42 weeks for gestational age; Apgar score less than 3 at minutes or delay in breathing more than 5 minutes after the birth; mixed metabolic acidosis with serum bicarbonate less than 12 mmol dL on initial ABG; evidence of mild or moderate encephalopathy; such as lethargy, seizures, abnormal neonatal reflexes, hypotonia, early on birthday. Exclusion criteria: Twin pregnancy; congenital malformation; chromosome abnormalities; maternal diabetes mellitus; maternal infection or chorioaminionitis; IUGR.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Clinical Changes. Timepoint: 6th month. Method of measurement: Denver Screening Test - Type 2.;Developmental Progression of Neurologic. Timepoint: 6th Month. Method of measurement: MRI And EEG.	—

Secondary

Measure	Time frame
Overall levels of nitrite and nitrate. Timepoint: Birth and two weeks after treatment. Method of measurement: Providing blood samples and spectrophotometric.;Side Effects. Timepoint: Two Weeks After The Treatment. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Abolfazl Khoshdel

Shahrekord University of Medical Sciences

fazelkh@skums.ac.ir+98 38 1222 0016

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026