Persistent Pulmonary Hypertension of the NewbornNCT05741229
The Effect Of Nebulizied Nitroglycerin As An Adjuvant Therapy For Persistent Pulmonary Hypertension Of Newborns
A study testing Nebulized nitroglycerine as adjunctive therapy and conventional therapy for PPHN in people with Persistent Pulmonary Hypertension of the Newborn and Echocardiography, run by Alexandria University at 1 site in Egypt.
Trial summary
This aim of the study is to evaluate the effect of nebulized nitroglycerin on echocardiographic (biventricular function, pulmonary artery pressure, PDA and PFO shunting and tissue doppler imaging) and clinical parameters (Oxygen saturation index, heart rate, blood pressure, mean airway pressure, ventilation setting)… Read more about this study
- Who is it for?
- Ages 1 hour to 7 days
- Conditions the study is for
- Persistent Pulmonary Hypertension of the Newborn, Echocardiography, Respiratory Disease
- What is being tested?
- Nebulized nitroglycerine as adjunctive therapy and conventional therapy for PPHN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 20 Jan 2025
- 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 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants ≤72 hours' old, ≥37 weeks of gestation, ≥50% FiO2 need despite lung recruitment, abnormal oxygen saturation index or echocardiographic signs of PPHN will be enrolled in the trial.
Who cannot join
- • Diagnosis of PPHN discovered after more than 72 hours.
- Failure of used medications and need to administrate milrinone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Nebulizied Nitroglycerin As An Adjuvant Drug In Management Of Persistent Pulmonary Hypertension Of Newborns
This aim of the study is to evaluate the effect of nebulized nitroglycerin on echocardiographic (biventricular function, pulmonary artery pressure, PDA and PFO shunting and tissue doppler imaging) and clinical parameters (Oxygen saturation index, heart rate, blood pressure, mean airway pressure, ventilation setting) in patients with PPHN.
- Being tested
- Nebulized nitroglycerine as adjunctive therapy, conventional therapy for PPHN
- Medical subject headings
- Persistent Fetal Circulation Syndrome, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized nitroglycerine as adjunctive therapyDrug
Patients with PPHN will have nebulized nitroglycerine as adjunctive therapy
conventional therapy for PPHNDrug
patients will receive sildenafil which is used routinely in management of PPHN in our unit, in addition to appropriate oxygenation and ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Group I (nebulized nitroglycerine) | Active comparator | Patients with persistent pulmonary hypertension (PPHN) and will receive nebulized nitroglycerine as an adjuvant therapy for PPHN Receives: Drug: Nebulized nitroglycerine as adjunctive therapy |
| Group II (conentional treatment group) | Placebo comparator | Patients with PPHN and will be treated with conventional regimen for PPHN Receives: Drug: conventional therapy for PPHN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of Pulmonary artery pressure (PAP)
Systolic pulmonary artery pressure (SPAP) can be estimated by measuring the peak velocity of tricuspid valve regurgitation with the use of the modified Bernoulli's equation.
- The estimation of SPAP by measuring TR is reliable and often equivalent to pressures measured in the catheter lab while using continuous wave Doppler. However, the accuracy depends on the quality of the acquired TR jet. An optimal quality TR jet shows a well demarcated envelope.
- Right atrial pressure (RAP) is usually not measured, and a value of 3- 5 mmHg is generally assumed.
Measured: first 7 days of life
Right ventricular (RV) function in ml/kg/min
- RV output and stroke distance in main pulmonary artery:
- CSA (cm) (Cross sectional area of PV by long axis parasternal RV outflow view - 2D - immediately beneath pulmonary annulus - mid-systole - inner edge to inner edge) = π x (radius)2 ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Long axis parasternal RV outflow view). 12. ✓ SV (ml/beat) (Stroke Volume = CSA x VTI).
- Output (L/min.) COP = SV x HR.
Measured: first 7 days of life
Left ventricular (LV)function in ml/kg/min
LV output and stroke distance in ascending aorta:
- CSA (cm) (Cross sectional area of AV by long axis parasternal view - 2D - immediately beneath aortic annulus - mid- systole - inner edge to inner edge) = π x (radius)2. ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Apical 5-chamber view).
- SV (ml/beat) (Stroke Volume = CSA x VTI).
- Output (L/min.) COP = SV x HR.
Measured: first 7 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 posted23 Feb 2023
- Study start1 Jan 2024
- Primary completion30 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Persistent Pulmonary Hypertension of the NewbornStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- None (open label)
- Enrolment
- 80 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
- Hesham Ghazal, PhD, Study chair, Alexandria UniversityAly Mohamed Abdel-Mohsen, PhD, Study director, Alexandria UniversityMoataz Shawky Rezk, MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741229
- Sponsor's protocol ID
- 0201737
- Status last verified
- Jun 2025
- First submitted
- 14 Feb 2023
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is available for meta-analysis or any useful study upon reasonable request to authors
Publications
Bethou A. Utility of Nebulized Magnesium Sulfate Therapy for Persistent Pulmonary Hypertension of Newborn. Indian J Pediatr. 2021 Aug;88(8):749-750. doi: 10.1007/s12098-021-03851-0. Epub 2021 Jun 23. No abstract available.
PubMed 34164785Farag MM, Ghazal HAE, Abdel-Mohsen AM, Rezk MA. Nebulized nitroglycerin as an adjuvant drug in management of persistent pulmonary hypertension of newborns: a randomized controlled trial. Eur J Pediatr. 2025 Sep 1;184(9):586. doi: 10.1007/s00431-025-06381-5.
PubMed 40888971
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Nebulizied Nitroglycerin As An Adjuvant Drug In Management Of Persistent Pulmonary Hypertension Of Newborns
- ClinicalTrials.gov ID
- NCT05741229
- Acronym / sponsor ID
- 0201737
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 23 Feb 2023 (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.
This aim of the study is to evaluate the effect of nebulized nitroglycerin on echocardiographic (biventricular function, pulmonary artery pressure, PDA and PFO shunting and tissue doppler imaging) and clinical parameters (Oxygen saturation index, heart rate, blood pressure, mean airway pressure, ventilation setting) in patients with PPHN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (nebulized nitroglycerine) | Active comparator | Drug: Nebulized nitroglycerine as adjunctive therapyPatients with persistent pulmonary hypertension (PPHN) and will receive nebulized nitroglycerine as an adjuvant therapy for PPHN |
| Group II (conentional treatment group) | Placebo comparator | Drug: conventional therapy for PPHNPatients with PPHN and will be treated with conventional regimen for PPHN |
Who may qualify
- Ages
- 1 hour to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants ≤72 hours' old, ≥37 weeks of gestation, ≥50% FiO2 need despite lung recruitment, abnormal oxygen saturation index or echocardiographic signs of PPHN will be enrolled in the trial.
Key exclusion criteria (2 listed)
- • Diagnosis of PPHN discovered after more than 72 hours.
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 |
|---|---|---|
| Nebulized nitroglycerine as adjunctive therapyPatients with PPHN will have nebulized nitroglycerine as adjunctive therapy | Drug | Group I (nebulized nitroglycerine) |
| conventional therapy for PPHNpatients will receive sildenafil which is used routinely in management of PPHN in our unit, in addition to appropriate oxygenation and ventilation. | Drug | Group II (conentional treatment group) |
Primary outcome
Estimation of Pulmonary artery pressure (PAP)
Time frame: first 7 days of life
Systolic pulmonary artery pressure (SPAP) can be estimated by measuring the peak velocity of tricuspid valve regurgitation with the use of the modified Bernoulli's equation. * The estimation of SPAP by measuring TR is reliable and often equivalent to pressures measured in the catheter lab while using continuous wave Doppler. However, the accuracy depends on the quality of the acquired TR jet. An optimal quality TR jet shows a well demarcated envelope. * Right atrial pressure (RAP) is usually not measured, and a value of 3- 5 mmHg is generally assumed.
Right ventricular (RV) function in ml/kg/min
Time frame: first 7 days of life
• RV output and stroke distance in main pulmonary artery: * CSA (cm) (Cross sectional area of PV by long axis parasternal RV outflow view - 2D - immediately beneath pulmonary annulus - mid-systole - inner edge to inner edge) = π x (radius)2 ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Long axis parasternal RV outflow view). 12. ✓ SV (ml/beat) (Stroke Volume = CSA x VTI). * Output (L/min.) COP = SV x HR.
Left ventricular (LV)function in ml/kg/min
Time frame: first 7 days of life
LV output and stroke distance in ascending aorta: * CSA (cm) (Cross sectional area of AV by long axis parasternal view - 2D - immediately beneath aortic annulus - mid- systole - inner edge to inner edge) = π x (radius)2. ✓ VTI (cm) (Velocity Time Integral or Stroke Distance = Distance over which blood travels in once cardiac cycle → Apical 5-chamber view). * SV (ml/beat) (Stroke Volume = CSA x VTI). * Output (L/min.) COP = SV x HR.
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 29 Jun 2025.
- Background: PubMed 34164785Bethou A. Utility of Nebulized Magnesium Sulfate Therapy for Persistent Pulmonary Hypertension of Newborn. Indian J Pediatr. 2021 Aug;88(8):749-750. doi: 10.1007/s12098-021-03851-0. Epub 2021 Jun 23. No abstract available.
- Derived from this study: PubMed 40888971Farag MM, Ghazal HAE, Abdel-Mohsen AM, Rezk MA. Nebulized nitroglycerin as an adjuvant drug in management of persistent pulmonary hypertension of newborns: a randomized controlled trial. Eur J Pediatr. 2025 Sep 1;184(9):586. doi: 10.1007/s00431-025-06381-5.
- Idea about neubilized medications in PPHNLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data is available for meta-analysis or any useful study upon reasonable request to authors
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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.
Hesham Ghazal, PhD study chair
Alexandria University
Aly Mohamed Abdel-Mohsen, PhD study director
Alexandria University
Moataz Shawky Rezk, MD 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 Nebulized nitroglycerine as adjunctive therapy and conventional therapy for PPHN in people with Persistent Pulmonary Hypertension of the Newborn and Echocardiography, 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 1 inclusion and 2 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 29 Jun 2025. 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?
Estimation of Pulmonary artery pressure (PAP) (time frame: first 7 days of life). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05741229, which also lists 2 linked publications.
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 29 Jun 2025.