NCT06950723

Brief Summary

Hypoxic-ischemic encephalopathy (HIE) is a dangerous illness that happens when a newborn's brain does not receive adequate oxygen and blood flow, which can result in serious effects such as cerebral palsy and epilepsy. Infant diagnosed with HIE required ventilator support and subsequently developed pneumonia. They experienced respiratory problems and feeding challenges. Chest Physical Therapy is the best modalities to clear chest and improve ventilation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

May 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

April 9, 2025

Last Update Submit

April 27, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Timing of Arterial blood gases improvement

    Time needed to improve Arterial blood gases due to CPT

    3-14 days

  • Timing required for clinical improvement

    Time needed to improve clinical signs due to CPT

    3-14 days

  • Timing needed for Mechanical Ventilation

    Time needed to Mechanical Ventilation support.

    3-7 days

  • Hospitalization time

    All staying duration need for the neonates from admission till discharge from the hospital.

    5-21 days

Study Arms (2)

Chest physical Therapy group

EXPERIMENTAL

Study group

Other: Chest Physical Therapy (CPT) modalities , Medical Treatment

Medical treatment group

EXPERIMENTAL

Control group

Other: Chest Physical Therapy (CPT) modalities , Medical Treatment

Interventions

Chest Physical Therapy (CPT) modalities in the form of postural drainage, percussion and vibration.

Chest physical Therapy groupMedical treatment group

Eligibility Criteria

Age1 Day - 10 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonates with chest problems post Hypoxic-ischemic encephalopathy

You may not qualify if:

  • Neonates with chest problems due to other Causes except post Hypoxic-ischemic encephalopathy.
  • unstable medical status
  • Neonates with Post-operative s' respiratory problems due to any reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Central Study Contacts

Elsayed Mehrem, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 30, 2025

Study Start

May 10, 2025

Primary Completion

June 10, 2025

Study Completion

July 15, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04