Hypoxic EncephalopathyNCT05652738
Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates
A study testing Passive cooling application and cooling using Blanket roll III in people with Hypoxic Encephalopathy and Birth Asphyxia, run by Alexandria University at 1 site in Egypt.
Trial summary
Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD). Read more about this study
- Who is it for?
- Ages 1 hour to 6 hours
- Conditions the study is for
- Hypoxic Encephalopathy, Birth Asphyxia, Neonatal Encephalopathy
- What is being tested?
- Passive cooling application and cooling using Blanket roll III
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 hour to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Evidence of perinatal/intrapartum hypoxia, as indicated by at least one of:
- Apgar score of less than or equal to 5 at 10 minutes
- Needing mechanical ventilation or ongoing resuscitation at 10 minutes
- PH in cord blood gas is less than 7.00 or a base excess worse than or equal to minus 12 mmol /L on cord/arterial/venous/capillary blood gas obtained within 60 minutes of birth.
- Evidence of moderate or severe encephalopathy.
- Greater than or equal to 35 weeks gestational age.
- Birth weight greater than or equal to 1800 g.
- Able to begin cooling before 6 hours of birth.
Who cannot join
- Congenital cyanotic heart disease.
- Multiple congenital anomalies.
- Birth asphyxia's babies after start of cooling with cardiovascular instability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates: A Randomized Clinical Trial
Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).
Read the detailed description
A clinical trial study of 100 Gestational-age-matched asphyxiated cooled neonates will divided into two groups, 50 in each group for comparison the myocardial function using passive cooling and BLANKET ROLL III as modality of TH.
- Being tested
- Passive cooling application, cooling using Blanket roll III
- Keywords
- therapeutic hypothermia, asphyxiated neonates, tissue Doppler
- Medical subject headings
- Hypoxia, Brain, Asphyxia Neonatorum, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive cooling applicationDevice
Passive cooling application for asphyxiated neonates and their effect on myocardial function and hemodynamics
cooling using Blanket roll IIIDevice
standard care using Blanket roll III in asphyxiated neonates and their effect on myocardial function and hemodynamics
| Study group | Role | What they receive |
|---|---|---|
| Group I: (passive cooling group) | Active comparator | Not described Receives: Device: Passive cooling application |
| Group II: (Blanket roll III cooling group) | Placebo comparator | Not described Receives: Device: cooling using Blanket roll III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial function through using tissue Doppler (TD).
neonatal echocardiography using a (Vivid IQ) with a (3-8 MHz) with software for Tissue Doppler imaging (TDI) , myocardial performance index and measuring velocities of different waveforms, cm/sec.
Measured: first 4 days of life
Left ventricular function through using conventional echocardiography.
Ejection fraction in percent .
Measured: first 4 days of life
Secondary outcomes (1)
Right ventricular function using conventional echocardiography
TAPSE (tricuspid annular plane systolic excursion) in mm .
Measured: first 4 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start20 Jan 2022
- Primary completion20 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic EncephalopathyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
- Investigators
- Reham M Wagdy, PhD, Principal investigator, Faculty of medicine, Alexandria University, EgyptHossam M Kamel, MBChB, Principal investigator, Faculty of medicine, Alexandria University, EgyptRasha M Adel Nasra, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652738
- Sponsor's protocol ID
- 0107176
- Status last verified
- May 2023
- First submitted
- 25 Nov 2022
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05652738
- Acronym / sponsor ID
- 0107176
- Keywords
- therapeutic hypothermia, asphyxiated neonates, tissue Doppler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 15 Dec 2022 (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.
Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).
Detailed description
A clinical trial study of 100 Gestational-age-matched asphyxiated cooled neonates will divided into two groups, 50 in each group for comparison the myocardial function using passive cooling and BLANKET ROLL III as modality of TH.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: (passive cooling group) | Active comparator | Device: Passive cooling application |
| Group II: (Blanket roll III cooling group) | Placebo comparator | Device: cooling using Blanket roll III |
Who may qualify
- Ages
- 1 hour to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Evidence of perinatal/intrapartum hypoxia, as indicated by at least one of:
- Evidence of moderate or severe encephalopathy.
- Greater than or equal to 35 weeks gestational age.
- Birth weight greater than or equal to 1800 g.
- Able to begin cooling before 6 hours of birth.
Key exclusion criteria (3 listed)
- Congenital cyanotic heart disease.
- Multiple congenital anomalies.
- Birth asphyxia's babies after start of cooling with cardiovascular instability.
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 |
|---|---|---|
| Passive cooling applicationPassive cooling application for asphyxiated neonates and their effect on myocardial function and hemodynamics | Device | Group I: (passive cooling group) |
| cooling using Blanket roll IIIstandard care using Blanket roll III in asphyxiated neonates and their effect on myocardial function and hemodynamics | Device | Group II: (Blanket roll III cooling group) |
Primary outcome
Myocardial function through using tissue Doppler (TD).
Time frame: first 4 days of life
neonatal echocardiography using a (Vivid IQ) with a (3-8 MHz) with software for Tissue Doppler imaging (TDI) , myocardial performance index and measuring velocities of different waveforms, cm/sec.
Left ventricular function through using conventional echocardiography.
Time frame: first 4 days of life
Ejection fraction in percent .
1 secondary outcome
Right ventricular function using conventional echocardiography
Time frame: first 4 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
Related trials for Hypoxic Encephalopathy
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
RecruitingPhase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal 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. This study is not recruiting at the moment.
Reham M Wagdy, PhD principal investigator
Faculty of medicine, Alexandria University, Egypt
Hossam M Kamel, MBChB principal investigator
Faculty of medicine, Alexandria University, Egypt
Rasha M Adel Nasra principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive cooling application and cooling using Blanket roll III in people with Hypoxic Encephalopathy and Birth Asphyxia, run by Alexandria University at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial function through using tissue Doppler (TD). (time frame: first 4 days of life). The study lists 2 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 16 May 2023.