Persistent Pulmonary Hypertension of the NewbornNCT04379180
Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN
An observational study of Persistent Pulmonary Hypertension of the Newborn, run by Shandong University at 1 site in China.
Trial summary
The use of bosentan, sildenafil and tadalafil in neonates with persistent pulmonary hypertension (PPHN) depends mostly on the empirical experience of pediatricians. Moreover, the recommended dose of those three drugs in treating PPHN remains controversial. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Persistent Pulmonary Hypertension of the Newborn
- What is being tested?
- Bosentan Tablets, Sildenafil Tablet and Tadalafil Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2020to 30 May 2023
- Phase
- Observational
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates suffered from persistent pulmonary hypertension
Who may be able to join
- Age: postnatal age ≤ 28 days;
- Patients have been diagnosed with PPHN;
- Bosentan, sildenafil and/or tadalafil used as part of regular treatment.
- Parental written consent
Who cannot join
- Expected survival time less than the treatment cycle;
- Major congenital malformations;
- Undergoing surgery within the first week of life;
- Receiving other systemic trial drug therapy;
- Other factors that the researcher considers unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Second University Hospital
Chengdu, Sichuan, 610041
Wei Zhao, Ph.D, 86053188383308, zhao4wei2@hotmail.com
About this study
Official title: Population Pharmacokinetics and Dosage Individualization of Bosentan, Sildenafil and Tadalafil in Persistent Pulmonary Hypertension of the Newborn
The use of bosentan, sildenafil and tadalafil in neonates with persistent pulmonary hypertension (PPHN) depends mostly on the empirical experience of pediatricians. Moreover, the recommended dose of those three drugs in treating PPHN remains controversial. Therefore, our aim is to study the pharmacokinetics and pharmacodynamics of bosentan, sildenafil and tadalafil in neonates of PPHN then dose a tailor-made therapeutic regimen.
- Being tested
- Bosentan Tablets, Sildenafil Tablet, Tadalafil Tablets
- Medical subject headings
- Persistent Fetal Circulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bosentan TabletsDrug
2mg/kg, bid
Sildenafil TabletDrug
1mg/kg, q6h/q8h
Tadalafil TabletsDrug
1mg/kg, qd
| Study group | Role | What they receive |
|---|---|---|
| Treatment(bosentan, sildenafil and tadalafil) | Not described Receives: Drug: Bosentan Tablets; Drug: Sildenafil Tablet; Drug: Tadalafil Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index
Oxygenation index=(fraction of inspired oxygen*mean airway pressure)/the partial pressure of arterial oxygen
Measured: The first 72 hours of the initial treatment
The change of hemodynamics
- Pulmonary artery pressure (mmHg)
- Alveolar-arterial gradient (mmHg)
Measured: Through study completion, an average of 5 days
Secondary outcomes (6)
Duration of hospitalization
Duration of initial therapy
Measured: Within the first 28 days of patients' life
Death
Death in the first 28 days of life
Measured: Within the first 28 days of patients' life
Adverse events
Drug-related adverse events and serious adverse events
Measured: Through study completion, an average of 5 days
Sequelae of PPHN
Including cerebral palsy, hearing impairment, neurodevelopmental outcome etc
Measured: Through study completion and a 6-month visit
The need of extra support
Besides the initial therapy (bosentan, sildenafil and/or tadalafil), other support such as inhaled nitric oxide (iNO), inotropic agents or Extracorporeal Membrane Oxygenation (ECMO)
Measured: Through study completion, an average of 5 days
Pulse oxygen saturation
Pulse oxygen saturation（%）
Measured: The first 72 hours of the initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start26 Apr 2020 (estimated)
- Primary completion26 Feb 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Pulmonary Hypertension of the NewbornStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Second University Hospital
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379180
- Sponsor's protocol ID
- 2020_PPHN_001
- Status last verified
- May 2020
- First submitted
- 26 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics and Dosage Individualization of Bosentan, Sildenafil and Tadalafil in Persistent Pulmonary Hypertension of the Newborn
- ClinicalTrials.gov ID
- NCT04379180
- Acronym / sponsor ID
- 2020_PPHN_001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- West China Second University Hospital
- Study start
- 26 Apr 2020 (estimated)
- Primary completion
- 26 Feb 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 7 May 2020 (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.
The use of bosentan, sildenafil and tadalafil in neonates with persistent pulmonary hypertension (PPHN) depends mostly on the empirical experience of pediatricians. Moreover, the recommended dose of those three drugs in treating PPHN remains controversial. Therefore, our aim is to study the pharmacokinetics and pharmacodynamics of bosentan, sildenafil and tadalafil in neonates of PPHN then dose a tailor-made therapeutic regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment(bosentan, sildenafil and tadalafil) | – | Drug: Bosentan Tablets, Drug: Sildenafil Tablet, Drug: Tadalafil Tablets |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates suffered from persistent pulmonary hypertension
Key inclusion criteria (4 listed)
- Age: postnatal age ≤ 28 days;
- Patients have been diagnosed with PPHN;
- Bosentan, sildenafil and/or tadalafil used as part of regular treatment.
- Parental written consent
Key exclusion criteria (5 listed)
- Expected survival time less than the treatment cycle;
- Major congenital malformations;
- Undergoing surgery within the first week of life;
- Receiving other systemic trial drug therapy;
- Other factors that the researcher considers unsuitable for inclusion.
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 |
|---|---|---|
| Bosentan Tablets2mg/kg, bid | Drug | Treatment(bosentan, sildenafil and tadalafil) |
| Sildenafil Tablet1mg/kg, q6h/q8h | Drug | Treatment(bosentan, sildenafil and tadalafil) |
| Tadalafil Tablets1mg/kg, qd | Drug | Treatment(bosentan, sildenafil and tadalafil) |
Primary outcome
Oxygenation index
Time frame: The first 72 hours of the initial treatment
Oxygenation index=(fraction of inspired oxygen*mean airway pressure)/the partial pressure of arterial oxygen
The change of hemodynamics
Time frame: Through study completion, an average of 5 days
* Pulmonary artery pressure (mmHg) * Alveolar-arterial gradient (mmHg)
6 secondary outcomes
Duration of hospitalization
Time frame: Within the first 28 days of patients' life
Death
Time frame: Within the first 28 days of patients' life
Adverse events
Time frame: Through study completion, an average of 5 days
Sequelae of PPHN
Time frame: Through study completion and a 6-month visit
The need of extra support
Time frame: Through study completion, an average of 5 days
Pulse oxygen saturation
Time frame: The first 72 hours of the initial treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Pulmonary Hypertension of the Newborn, run by Shandong University at 1 site in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 May 2020. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation index (time frame: The first 72 hours of the initial treatment). 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 7 May 2020.