Does Folinic acid supplementation affect the outcome in neonates with Hypoxic ischemic encephalopathy?

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260309001

Enrollment

270

Registered

2026-03-09

Start date

2026-02-21

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

hypoxic Ischemic encephalopathy neonates, hypoxic Ischemic encephalopathy. Folinic acid, neurodevelopment outcome

Interventions

folinic acid 2.5mg per dose twice a day for 5 days

Experimental Dietary Supplement

Folinic acid

Eligibility

Sex/Gender

All

Age

1 Hours to 28 Days

Inclusion criteria

Inclusion criteria: All neonates more than 37 weeks of gestation with hypoxic ischemic encephalopathy Age less than 24 hours

Exclusion criteria

Exclusion criteria: Any neonate with underlying congenital structural neurological problem, congenital heart defect, inborn error of metabolism and sepsis

Design outcomes

Primary

Measure	Time frame
cerebral folate levels Cerebrospinal fluid analysis after 5 days treatment Cerebrospinal fluid analysis,neurodevelopment outcome at 3 and 6 months of age schedule of growing skills II,Ventricular size and cortical thickness at discharge and at 3 and 6 months cranial Ultrasound,The short-term outcome will be measured in terms of early initiation of feed, early seizure control, duration of stay, outcome (discharge/death) at initial disposition clinical examination	—

Measure

Time frame

cerebral folate levels Cerebrospinal fluid analysis after 5 days treatment Cerebrospinal fluid analysis,neurodevelopment outcome at 3 and 6 months of age schedule of growing skills II,Ventricular size and cortical thickness at discharge and at 3 and 6 months cranial Ultrasound,The short-term outcome will be measured in terms of early initiation of feed, early seizure control, duration of stay, outcome (discharge/death) at initial disposition clinical examination

—

Secondary

Measure	Time frame
Neurodevelopment outcome after 6 months Schedule of growing skills II	—

Countries

Pakistan

Contacts

Public ContactBushra Fatima

University of child health sciences, Lahore

fatimaalvi2000@yahoo.com03364472031

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026