Persistent Pulmonary Hypertension of the NewbornNCT06562036
Efficacy of Milrinone With Sildenafil in Persistent Pulmonary Hypertension in Children
A study testing Sildenafil and Milrinone in people with Persistent Pulmonary Hypertension of the Newborn, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Neonates with persistent pulmonary hypertension (PPH) should be administered inhaled nitric oxide (iNO) and extracorporeal membrane oxygenation (ECMO), but these are not available in most resource-constrained settings like ours. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Persistent Pulmonary Hypertension of the Newborn
- What is being tested?
- Sildenafil and Milrinone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 31 May 2024
- 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 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of either gender
- Aged between 1-28 days
- Birth weight above 2000 grams
- Diagnosed with persistent pulmonary hypertension (as per echocardiography)
Who cannot join
- Neonates having congenital heart defects (CHDs)
- Congenital diaphragmatic hernia
- Lung anomalies
- History of any surgical intervention
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Children's Hospital and institute of Child Health
Multan, Punjab Province, 60000
About this study
Official title: Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension: A Single-Center, Randomized Controlled Trial
Neonates with persistent pulmonary hypertension (PPH) should be administered inhaled nitric oxide (iNO) and extracorporeal membrane oxygenation (ECMO), but these are not available in most resource-constrained settings like ours. This study was planned to compare the outcomes of Milrinone plus Sildenafil versus Sildenafil alone in the treatment of PPH in neonates.
- Being tested
- Sildenafil, Milrinone
- 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.
SildenafilDrug
Patients were given oral sildenafil as 2 mg per kg per day, 6-hourly with an increment of 0.5 mg per kg per dose and a target maintenance dose of 2 mg per kg per dose every 6 hour by nasogastric tube.
MilrinoneDrug
In this group, Milrinone was initiated at 0.5 ug per kg per minute using intravenous infusion through a syringe pump, and sildenafil was given in the same protocol mentioned for the Sildenafil Group.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | Patients were given oral sildenafil at 2 mg per kg per day, 6-hourly, with an increment of 0.5 mg per kg per dose and a target maintenance dose of 2 mg per kg per dose every 6 hours by nasogastric tube. Receives: Drug: Sildenafil |
| Sildenafil + Milrinone | Experimental | In this group, Milrinone was initiated at 0.5 ug per kg per minute using intravenous infusion through a syringe pump, and sildenafil was given in the same protocol mentioned for the Sildenafil Group. Receives: Drug: Sildenafil; Drug: Milrinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary artery systolic pressure
Efficacy was labeled yes if there was adecrease in pulmonary artery systolic pressure (PASP)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Dec 2023
- Primary completion31 May 2024
- Study completion31 May 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Muhammad Awais, FCPS, Principal investigator, Children's Hospital and institute of Child Health Multan, Punjab, PakistanAbdur Rehman, FCPS, Study director, Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562036
- Sponsor's protocol ID
- DRAWAIS
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with other researchers on a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension: A Single-Center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06562036
- Acronym / sponsor ID
- DRAWAIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 20 Aug 2024 (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.
Neonates with persistent pulmonary hypertension (PPH) should be administered inhaled nitric oxide (iNO) and extracorporeal membrane oxygenation (ECMO), but these are not available in most resource-constrained settings like ours. This study was planned to compare the outcomes of Milrinone plus Sildenafil versus Sildenafil alone in the treatment of PPH in neonates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: SildenafilPatients were given oral sildenafil at 2 mg per kg per day, 6-hourly, with an increment of 0.5 mg per kg per dose and a target maintenance dose of 2 mg per kg per dose every 6 hours by nasogastric tube. |
| Sildenafil + Milrinone | Experimental | Drug: Sildenafil, Drug: MilrinoneIn this group, Milrinone was initiated at 0.5 ug per kg per minute using intravenous infusion through a syringe pump, and sildenafil was given in the same protocol mentioned for the Sildenafil Group. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients of either gender
- Aged between 1-28 days
- Birth weight above 2000 grams
- Diagnosed with persistent pulmonary hypertension (as per echocardiography)
Key exclusion criteria (4 listed)
- Neonates having congenital heart defects (CHDs)
- Congenital diaphragmatic hernia
- Lung anomalies
- History of any surgical intervention
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 |
|---|---|---|
| SildenafilPatients were given oral sildenafil as 2 mg per kg per day, 6-hourly with an increment of 0.5 mg per kg per dose and a target maintenance dose of 2 mg per kg per dose every 6 hour by nasogastric tube. | Drug | Sildenafil, Sildenafil + Milrinone |
| MilrinoneIn this group, Milrinone was initiated at 0.5 ug per kg per minute using intravenous infusion through a syringe pump, and sildenafil was given in the same protocol mentioned for the Sildenafil Group. | Drug | Sildenafil + Milrinone |
Primary outcome
Change in pulmonary artery systolic pressure
Time frame: 72 hours
Efficacy was labeled yes if there was adecrease in pulmonary artery systolic pressure (PASP)
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 26 Aug 2024.
- Individual participant dataSharing planned: No. Data can be shared with other researchers on a reasonable request
Related trials for Persistent Pulmonary Hypertension of the Newborn
Recruiting
Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates
Congenital Peumonia, Persistent Pulmonary Hypertension of Newborn
Not yet recruitingObservational study
Post Market Clinical Follow-up to Assess the Portable Nitric Oxide Generation and Delivery System (INOwill N200) for the Treatment of Neonatal Hypoxic Respiratory Failure Complicated by Pulmonary Hypertension
Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
Not yet recruitingObservational study
Predictors of Outcomes in Pulmonary Hypertension of the Newborn
Hypertension, Pulmonary, Infant, Newborn, Diseases
Recruiting
Close Loop Smart Weaning for INO With PPHN
Persistent Pulmonary Hypertension of the Newborn, Inhaled Nitric Oxide
Active, not recruiting
Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension
Persistent Pulmonary Hypertension of the Newborn, Hypoxemic Respiratory Failure
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.
Muhammad Awais, FCPS principal investigator
Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
Abdur Rehman, FCPS study director
Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sildenafil and Milrinone in people with Persistent Pulmonary Hypertension of the Newborn, run by Muhammad Aamir Latif at 1 site in Pakistan.
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 4 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 26 Aug 2024. 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 Pakistan. 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?
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?
Change in pulmonary artery systolic pressure (time frame: 72 hours). 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 26 Aug 2024.