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Not yet recruitingNCT06950723Updated Apr 30, 2025

Chest Physical Therapy on Arterial Blood Gases for Neonates Post Hypoxic Ischemic Encephalopathy

An interventional study of Chest Physical Therapy (CPT) modalities , Medical Treatment in Hypoxic Ischemic Encephalopathy of Newborn, sponsored by Cairo University. Not yet recruiting. Open to participants aged 1 Day to 10 Days. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.

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Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
1 Day to 10 Days
Sex
All
01

Study 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.

Read the detailed description

The purpose of this study to investigate the effect of chest physical therapy on Arterial Blood Gases for neonates post hypoxic ischemic encephalopathy (HIE) in Neonatal intensive care unit.

Methods: Fifty neonates from both sexes, age from birth to 10 days, post HIE with chest problems were selected from neonatal intensive care unit (NICU) at Minia University hospital, Egypt. They were divided into two equal groups, control group (CG) received traditional medical treatment according to American Academy of Pediatrics (AAP) recommendations and study group (SG) received traditional medical treatment plus Chest Physical Therapy (CPT) modalities in the form of postural drainage, percussion and vibration. The sessions will apply once daily for 6 days/week, each session is about 30 minutes, according to the neonate tolerance till complete clinical cure and discharge from NICU.

the outcome will measure by Timing of Arterial blood gases improvement, Duration required for clinical improvement, Duration of Mechanical ventilation, Duration of Hospitalization.

02

Conditions studied

  • Hypoxic Ischemic Encephalopathy of Newborn
03

In context

Hypoxia-Ischemia, Brain

261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.

Browse Hypoxia-Ischemia, Brain studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,457 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 10 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Neonates with chest problems post Hypoxic-ischemic encephalopathy

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Chest physical Therapy group

    Study group

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

  • Experimental
    Medical treatment group

    Control group

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

Interventions

  • OtherChest Physical Therapy (CPT) modalities , Medical Treatment

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

06

What researchers measure

Primary outcomes

  1. Timing of Arterial blood gases improvement

    Time needed to improve Arterial blood gases due to CPT

    Time frame: 3-14 days

  2. Timing required for clinical improvement

    Time needed to improve clinical signs due to CPT

    Time frame: 3-14 days

  3. Timing needed for Mechanical Ventilation

    Time needed to Mechanical Ventilation support.

    Time frame: 3-7 days

  4. Hospitalization time

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

    Time frame: 5-21 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2025; primary completion for Jun 2025, 1 month later.

Of 46 non-industry interventional studies with no phase under Hypoxia-Ischemia, Brain, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 63. This study's planned 1 month is below that.

Counting every sponsor, half of 47 studies reached it within 33 months; a quarter within 19 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2025
First posted
Apr 30, 2025
StartEst.
May 10, 2025
Primary completionEst.
Jun 10, 2025
CompletionEst.
Jul 15, 2025
Last update
Apr 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06950723
Lead sponsor
Cairo University
Responsible party
Elsayed Mehrem (Principal Investigator, Cairo University) — Principal investigator
First posted
Apr 30, 2025
Start date
May 10, 2025 (estimated)
Primary completion
Jun 10, 2025 (estimated)
Completion
Jul 15, 2025 (estimated)
Last update
Apr 30, 2025

Study contacts

Elsayed Mehrem, Associate Professor
Contact
sayed7555@yahoo.com
+201006973334

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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