Hypertension, PulmonaryNCT07822750
Predictors of Outcomes in Pulmonary Hypertension of the Newborn
An observational study of Hypertension, Pulmonary and Infant, Newborn, Diseases, run by Assiut University.
Trial summary
This prospective cohort study aims to identify the clinical, laboratory, and echocardiographic predictors of outcomes among neonates diagnosed with persistent pulmonary hypertension of the newborn at Assiut University Children Hospital. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Hypertension, Pulmonary, Infant, Newborn, Diseases
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 1 Feb 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Term and preterm neonates admitted to the Neonatal Intensive Care Unit of Assiut University Children Hospital with clinical and echocardiographic evidence of persistent pulmonary hypertension.
Who may be able to join
- - Neonates (term and preterm) admitted to the NICU
- Clinical and echocardiographic evidence of pulmonary hypertension
- Written informed consent from parents or legal guardians
Who cannot join
- - Major structural cyanotic congenital heart disease
- Lethal congenital anomalies or chromosomal abnormalities incompatible with survival
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
This prospective cohort study aims to identify the clinical, laboratory, and echocardiographic predictors of outcomes among neonates diagnosed with persistent pulmonary hypertension of the newborn at Assiut University Children Hospital.
Read the detailed description
Persistent pulmonary hypertension of the newborn (PPHN) is a serious condition characterized by failure of the normal postnatal decline in pulmonary vascular resistance, leading to severe hypoxemia. Outcomes vary widely, ranging from complete recovery to death.
This observational study will include term and preterm neonates admitted to the NICU with clinical and echocardiographic evidence of pulmonary hypertension. Clinical, laboratory, and echocardiographic parameters will be recorded to identify predictors of mortality and other adverse outcomes.
- Conditions
- Hypertension, Pulmonary, Infant, Newborn, Diseases
- Keywords
- hypertension of the newborn, Neonatal outcomes, PPHN, Mortality, Persistent pulmonary, Echocardiography, Assiut
- Medical subject headings
- Hypertension, Pulmonary, Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: Neonates with PPHN | Term and preterm neonates with clinical and echocardiographic evidence of persistent pulmonary hypertension who will be followed for clinical, laboratory, and echocardiographic predictors of outcome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Proportion of neonates with persistent pulmonary hypertension who die before hospital discharge.
Measured: Up to 30 days
Secondary outcomes (6)
Duration of mechanical ventilation
Total number of days of invasive mechanical ventilation.
Measured: Up to 30 days
Duration of oxygen therapy
Total number of days requiring supplemental oxygen.
Measured: Up to 30 days
Use of sildenafil
Proportion of neonates who receive sildenafil therapy.
Measured: Up to 30 days
Use of inotropes
Proportion of neonates who receive inotropic support
Measured: Up to 30 days
Duration of NICU stay
Length of stay in the neonatal intensive care unit in days.
Measured: Up to 30 days
Time to echocardiographic resolution
Number of days from diagnosis until echocardiographic resolution of pulmonary hypertension.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Saleh Mohammed, Assiut University
- Investigators
- Nagwa A Mohammed, prof, Study chair, pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822750
- Sponsor's protocol ID
- PPHN-Outcomes-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reid H, Hocking C, Smythe E. Occupational therapy's oversight: How science veiled our humanity. Scand J Occup Ther. 2024 Dec;31(1):2306585. doi: 10.1080/11038128.2024.2306585. Epub 2024 Jan 23.
PubMed 38261715Xiaowan Y, Gang L. Bone Toothbrush Handles in Chinese Tang Dynasty Ash Pits. J Hist Dent. 2024 Summer/Fall;72(2):162-164. doi: 10.58929/jhd.2024.072.02.162.
PubMed 39180735Liu CR, Wan LP, Liu BP, Jia CX, Liu X. Depressive symptoms mediate the association between maternal authoritarian parenting and non-suicidal self-injury among Chinese adolescents. J Affect Disord. 2022 May 15;305:213-219. doi: 10.1016/j.jad.2022.03.008. Epub 2022 Mar 10.
PubMed 35278486
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Outcomes in Pulmonary Hypertension of the Newborn
- ClinicalTrials.gov ID
- NCT07822750
- Acronym / sponsor ID
- PPHN-Outcomes-Assiut-2026
- Conditions
- Hypertension, Pulmonary, Infant, Newborn, Diseases
- Keywords
- hypertension of the newborn, Neonatal outcomes, PPHN, Mortality, Persistent pulmonary, Echocardiography, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 16 Sep 2026 (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 prospective cohort study aims to identify the clinical, laboratory, and echocardiographic predictors of outcomes among neonates diagnosed with persistent pulmonary hypertension of the newborn at Assiut University Children Hospital.
Detailed description
Persistent pulmonary hypertension of the newborn (PPHN) is a serious condition characterized by failure of the normal postnatal decline in pulmonary vascular resistance, leading to severe hypoxemia. Outcomes vary widely, ranging from complete recovery to death.
This observational study will include term and preterm neonates admitted to the NICU with clinical and echocardiographic evidence of pulmonary hypertension. Clinical, laboratory, and echocardiographic parameters will be recorded to identify predictors of mortality and other adverse outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Neonates with PPHN | – | –Term and preterm neonates with clinical and echocardiographic evidence of persistent pulmonary hypertension who will be followed for clinical, laboratory, and echocardiographic predictors of outcome. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term and preterm neonates admitted to the Neonatal Intensive Care Unit of Assiut University Children Hospital with clinical and echocardiographic evidence of persistent pulmonary hypertension.
Key inclusion criteria (3 listed)
- - Neonates (term and preterm) admitted to the NICU
- Clinical and echocardiographic evidence of pulmonary hypertension
- Written informed consent from parents or legal guardians
Key exclusion criteria (2 listed)
- - Major structural cyanotic congenital heart disease
- Lethal congenital anomalies or chromosomal abnormalities incompatible with survival
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality
Time frame: Up to 30 days
Proportion of neonates with persistent pulmonary hypertension who die before hospital discharge.
6 secondary outcomes
Duration of mechanical ventilation
Time frame: Up to 30 days
Duration of oxygen therapy
Time frame: Up to 30 days
Use of sildenafil
Time frame: Up to 30 days
Use of inotropes
Time frame: Up to 30 days
Duration of NICU stay
Time frame: Up to 30 days
Time to echocardiographic resolution
Time frame: Up to 30 days
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 16 Sep 2026.
- Background: PubMed 38261715Reid H, Hocking C, Smythe E. Occupational therapy's oversight: How science veiled our humanity. Scand J Occup Ther. 2024 Dec;31(1):2306585. doi: 10.1080/11038128.2024.2306585. Epub 2024 Jan 23.
- Background: PubMed 39180735Xiaowan Y, Gang L. Bone Toothbrush Handles in Chinese Tang Dynasty Ash Pits. J Hist Dent. 2024 Summer/Fall;72(2):162-164. doi: 10.58929/jhd.2024.072.02.162.
- Background: PubMed 35278486Liu CR, Wan LP, Liu BP, Jia CX, Liu X. Depressive symptoms mediate the association between maternal authoritarian parenting and non-suicidal self-injury among Chinese adolescents. J Affect Disord. 2022 May 15;305:213-219. doi: 10.1016/j.jad.2022.03.008. Epub 2022 Mar 10.
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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.
Nagwa A Mohammed, prof study chair
pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary and Infant, Newborn, Diseases, run by Assiut 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 3 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: opening soon, as of the sponsor's last update on 16 Sep 2026. 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 Aya s Mohamed, Resident (+20 10 20640170, ayat.18313253@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: Up to 30 days). 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 NCT07822750, which also lists 3 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 16 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.