NCT06522581

Brief Summary

Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births. Infants afflicted with moderate HIE face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. The prognosis is graver for severe HIE, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

July 22, 2024

Last Update Submit

August 12, 2024

Conditions

Hypoxic Ischemic Encephalopathy of Newborn

Outcome Measures

Primary Outcomes (1)

  • survival in newborn babies with HIE

    we will be evaluationg the efficacy of citicoline in newborns with HIE

    one year after the start of study

Study Arms (2)

neonates with HIE receiving citicoline

EXPERIMENTAL

this arm will include neonates suffering from hypoxic ischemic encephalopathy and who will be given injection citicoline

Drug: Citicoline Sodium

neonates with HIE receiving placebo

PLACEBO COMPARATOR

this arm will include neonates who will be suffering from HIE but will recieve rotuine care in NICU but will not receive injection citicoline

Drug: Citicoline Sodium

Interventions

Citicoline SodiumDRUG

one group of neonates with confirmed HIE grade II and III will receive injection citicoline through IV route within 06 hours of birth

Also known as: placebo
neonates with HIE receiving citicolineneonates with HIE receiving placebo

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all indoor newborn babies with HIE II and III
  • who have not received therapeutic hypothermia

You may not qualify if:

  • grade I HIE
  • Babies on TH
  • babies with major congential malformations -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MH

Rawalpindi, 68000, Pakistan

RECRUITING

Study Officials

  • arshad Khushdil, FCPS

    PEMH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

arshad Khushdil

CONTACT

03463300030drarshad104589@yahoo.com

arshad Khushdil

CONTACT

03463300030

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 26, 2024

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

August 14, 2024

Record last verified: 2024-08

Locations

PA(1)