Hypoxic Ischemic Encephalopathy of NewbornNCT06950723
Chest Physical Therapy on Arterial Blood Gases for Neonates Post Hypoxic Ischemic Encephalopathy
A study testing Chest Physical Therapy (CPT) modalities , Medical Treatment in people with Hypoxic Ischemic Encephalopathy of Newborn, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 10 days
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy of Newborn
- What is being tested?
- Chest Physical Therapy (CPT) modalities , Medical Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with chest problems post Hypoxic-ischemic encephalopathy
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Chest Physical Therapy on Arterial Blood Gases for Neonates Post Hypoxic Ischemic Encephalopathy in Neonatal Intensive Care Unit: A Clinical Trial Study
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.
- Being tested
- Chest Physical Therapy (CPT) modalities , Medical Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Physical Therapy (CPT) modalities , Medical TreatmentOther
Chest Physical Therapy (CPT) modalities in the form of postural drainage, percussion and vibration.
| Study group | Role | What they receive |
|---|---|---|
| Chest physical Therapy group | Experimental | Study group Receives: Other: Chest Physical Therapy (CPT) modalities , Medical Treatment |
| Medical treatment group | Experimental | Control group Receives: Other: Chest Physical Therapy (CPT) modalities , Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of Arterial blood gases improvement
Time needed to improve Arterial blood gases due to CPT
Measured: 3-14 days
Timing required for clinical improvement
Time needed to improve clinical signs due to CPT
Measured: 3-14 days
Timing needed for Mechanical Ventilation
Time needed to Mechanical Ventilation support.
Measured: 3-7 days
Hospitalization time
All staying duration need for the neonates from admission till discharge from the hospital.
Measured: 5-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start10 May 2025 (estimated)
- Primary completion10 Jun 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Ischemic Encephalopathy of NewbornStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Mehrem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950723
- Sponsor's protocol ID
- Sayed75
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chest Physical Therapy on Arterial Blood Gases for Neonates Post Hypoxic Ischemic Encephalopathy in Neonatal Intensive Care Unit: A Clinical Trial Study
- ClinicalTrials.gov ID
- NCT06950723
- Acronym / sponsor ID
- Sayed75
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 May 2025 (estimated)
- Primary completion
- 10 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest physical Therapy group | Experimental | Other: Chest Physical Therapy (CPT) modalities , Medical TreatmentStudy group |
| Medical treatment group | Experimental | Other: Chest Physical Therapy (CPT) modalities , Medical TreatmentControl group |
Who may qualify
- Ages
- 1 day to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates with chest problems post Hypoxic-ischemic encephalopathy
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest Physical Therapy (CPT) modalities , Medical TreatmentChest Physical Therapy (CPT) modalities in the form of postural drainage, percussion and vibration. | Other | Chest physical Therapy group, Medical treatment group |
Primary outcome
Timing of Arterial blood gases improvement
Time frame: 3-14 days
Time needed to improve Arterial blood gases due to CPT
Timing required for clinical improvement
Time frame: 3-14 days
Time needed to improve clinical signs due to CPT
Timing needed for Mechanical Ventilation
Time frame: 3-7 days
Time needed to Mechanical Ventilation support.
Hospitalization time
Time frame: 5-21 days
All staying duration need for the neonates from admission till discharge from the hospital.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
Related trials for Hypoxic Ischemic Encephalopathy of Newborn
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
RecruitingPhase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal Encephalopathy
RecruitingObservational study
Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia
Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy
Not yet recruitingObservational study
Newborn Brain Assessment - CergenX Wave
Neonatal Encephalopathy, Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Chest Physical Therapy (CPT) modalities , Medical Treatment in people with Hypoxic Ischemic Encephalopathy of Newborn, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elsayed Mehrem, Associate Professor (+201006973334, sayed7555@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of Arterial blood gases improvement (time frame: 3-14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.