Hypertension, PulmonaryHIPSENNCT04912726
Endovenous Sildenafil Early Management in Newborns Pulmonary Hypertension
A study testing Sildenafil Injectable Product in people with Hypertension, Pulmonary, run by Universidad del Norte.
Trial summary
Sildenafil is currently approved for the management of pulmonary hypertension of the newborn, with the availability of intravenous presentation it has been seen that the severity condition has already established, many times these patients do not have the adequate clinical response and there are no studies to date… Read more about this study
- Who is it for?
- Ages Up to 10 days
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Sildenafil Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Dec 2026
- 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 Up to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with gestational age ≥ 34 weeks and less than 10 days old, from the delivery room, joint accommodation, surgery at the Niño Jesus Hospital and referred from other institutions with an echocardiographic diagnosis of persistent pulmonary hypertension of the newborn. A diagnosis of persistent pulmonary hypertension of the newborn will be made if any of the following criteria are identified in the absence of cyanotic congenital heart disease by echocardiography: Tricuspid regurgitant jet with a pressure gradient ≥ 2/3 of systemic systolic blood pressure; intraventricular septum that flattens or slopes into the left ventricular cavity; bidirectional or right-to-left flow through patent ductus arteriosus; pulmonary artery acceleration time <40 milliseconds
Who cannot join
- Congenital heart disease or fatal congenital anomalies
- Oxygenation Index (IO) > 15
- No parental consent
About this study
Official title: Efficacy and Safety of Endovenous Sildenafil Early Management in Newborns Pulmonary Hypertension: a Clinical Trial
Sildenafil is currently approved for the management of pulmonary hypertension of the newborn, with the availability of intravenous presentation it has been seen that the severity condition has already established, many times these patients do not have the adequate clinical response and there are no studies to date that evaluate the efficacy and safety of the same when it is started early in these patients, therefore we plan a randomized clinical trial to determine the efficacy and safety of the administration of intravenous sildenafil for early management of newborns with persistent pulmonary hypertension of the newborn.
Read the detailed description
Persistent pulmonary hypertension of the newborn is a relatively common condition that occurs in 2 to 7/1000 live births, being higher in term and late preterm newborns, representing up to 4% of all admissions in some units neonatal intensive care and that results in a mortality that ranges between 4 and 33% in the world. In the United States, its incidence varies between 0.4 and 6.8 per 1000 live births, while in the United Kingdom it is between 0.43 and 6 per 1000 live births. Although there has been an important development in the treatment of persistent pulmonary hypertension of the newborn in the last time, its impact on early neonatal mortality continues to be important, reaching approximately 10%. Currently there are no mortality data in underdeveloped countries and in Latin America. This considerable mortality is most likely a consequence of the fact that 40% of newborns are resistant to inhaled nitric oxide, which, together with supportive therapies, is the basis of treatment. Furthermore, the increasing cost of administering Nitric oxide to infants with pulmonary hypertension of the newborn reduces its availability in developing countries. On the other hand, extracorporeal membrane oxygenation is another therapeutic option that is currently being systematically evaluated in clinical trials, even so, it is not available in all units. Therefore, there was a real need to evaluate novel approaches for the management of the disease, being necessary to create therapeutic strategies that allow improving the prognosis of these newborns. Sildenafil is currently approved for the management of persistent pulmonary hypertension of the newborn, with the availability of intravenous presentation it has been seen that once the severity picture has been established, many times these patients do not have the adequate clinical response and there are no studies to date that evaluate the efficacy and safety of the same when started early in these patients.
Primary outcome: To assess the efficacy in decreasing estimated pulmonary artery pressure by 20% and improving survival with early use of intravenous sildenafil at a loading dose of 0.4 mg / kg in 3 hours, followed of continuous infusion at 1.6 mg / kg / day versus conventional treatment plus placebo in neonates with persistent pulmonary hypertension of the newborn.
Materials and methods:
A total of 44 newborns with a gestational age ≥ 34 weeks of age and less than 10 days old who were admitted to the Neonatal Intensive Care Unit, High Complexity Medicine with a diagnosis of persistent pulmonary hypertension of the newborn in absentia, were evaluated. of congenital heart disease or oxygenation index greater than 15, attended between May 2021 and May 2022 in the city of Barranquilla, 22 were divided into two groups for the control group and 22 for the intervention group. the intervention group received intravenous sildenafil loading dose of 0.4 mg / kg in 3 hours and continued in continuous infusion at 1.6 mg / kg / day (0.067 mg / kg / h). The control group will receive placebo at the same loading dose and infusion with 0.9% saline solution plus standard management under the unit protocol immediately after the echocardiographic diagnosis. The measure of the primary outcome was given by the decrease of 20% in the estimated pressure of the pulmonary artery by echocardiography at 24 hours after the start of treatment, at 48 hours, between 96 - 168 hours and 48 hours after the drug discontinuation.
Results and conclusions: ongoing.
Declaration of conflict of interest: The authors do not present any situation of real, potential or evident conflict of interest, including any financial or other interest.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Sildenafil Injectable Product
- Keywords
- newborn, intravenous sildenafil, Hypertension, Pulmonary
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil Injectable ProductDrug
Also called Intravenous sildenafil
The intervention group will receive intravenous sildenafil loading dose of 0.4 mg / kg in 3 hours and continue in continuous infusion at 1.6 mg / kg / day (0.067 mg / kg / h).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will receive intravenous sildenafil loading dose of 0.4 mg / kg in 3 hours and continue in continuous infusion at 1.6 mg / kg / day (0.067 mg / kg / h). Receives: Drug: Sildenafil Injectable Product |
| Placebo | No intervention | The control group will receive placebo at the same loading dose and infusion with 0.9% saline solution plus standard management under the unit protocol immediately after the echocardiographic diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
20% decrease in estimated pulmonary artery pressure
Evaluate the efficacy in lowering the estimated pulmonary artery pressure by 20% and improved survival with early use of intravenous sildenafil at a loading dose of 0.4 mg / kg in 3 hours, followed by continuous infusion at 1.6 mg / kg / day versus conventional treatment plus placebo in neonates with persistent pulmonary hypertension of the newborn.
Measured: 7 days
Secondary outcomes (3)
Duration of mechanical ventilation
Evaluate the duration of mechanical ventilation with early use of intravenous sildenafil at a loading dose of 0.4 mg / kg in 3 hours, followed by continuous infusion at 1.6 mg / kg / day versus conventional treatment plus placebo in neonates with persistent pulmonary hypertension of the newborn.
Measured: 7 days
Duration of inotropic therapy
To assess the duration of inotropic therapy with early use of intravenous sildenafil at a loading dose of 0.4 mg / kg in 3 hours, followed by continuous infusion at 1.6 mg / kg / day versus conventional treatment. plus placebo in neonates with persistent pulmonary hypertension of the newborn.
Measured: 7 days
Adverse events
Correlate the presence of adverse events such as arterial hypotension, the presence of bleeding and retinopathy of prematurity with the early use of intravenous sildenafil at a loading dose of 0.4 mg / kg in 3 hours, followed by continuous infusion at 1.6 mg / kg / day versus conventional treatment plus placebo in neonates with persistent pulmonary hypertension of the newborn.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jan 2025 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: The study did not begin due to lack of resources for its execution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, double-blind clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912726
- Sponsor's protocol ID
- 234
- Acronym
- HIPSEN
- Status last verified
- Dec 2024
- First submitted
- 24 May 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martinho S, Adao R, Leite-Moreira AF, Bras-Silva C. Persistent Pulmonary Hypertension of the Newborn: Pathophysiological Mechanisms and Novel Therapeutic Approaches. Front Pediatr. 2020 Jul 24;8:342. doi: 10.3389/fped.2020.00342. eCollection 2020.
PubMed 32850518Jain A, McNamara PJ. Persistent pulmonary hypertension of the newborn: Advances in diagnosis and treatment. Semin Fetal Neonatal Med. 2015 Aug;20(4):262-71. doi: 10.1016/j.siny.2015.03.001. Epub 2015 Apr 2.
PubMed 25843770Fuloria M, Aschner JL. Persistent pulmonary hypertension of the newborn. Semin Fetal Neonatal Med. 2017 Aug;22(4):220-226. doi: 10.1016/j.siny.2017.03.004. Epub 2017 Mar 23.
PubMed 28342684Baquero H, Soliz A, Neira F, Venegas ME, Sola A. Oral sildenafil in infants with persistent pulmonary hypertension of the newborn: a pilot randomized blinded study. Pediatrics. 2006 Apr;117(4):1077-83. doi: 10.1542/peds.2005-0523.
PubMed 16585301Pedersen J, Hedegaard ER, Simonsen U, Kruger M, Infanger M, Grimm D. Current and Future Treatments for Persistent Pulmonary Hypertension in the Newborn. Basic Clin Pharmacol Toxicol. 2018 Oct;123(4):392-406. doi: 10.1111/bcpt.13051. Epub 2018 Jul 19.
PubMed 29855164Lakshminrusimha S, Mathew B, Leach CL. Pharmacologic strategies in neonatal pulmonary hypertension other than nitric oxide. Semin Perinatol. 2016 Apr;40(3):160-73. doi: 10.1053/j.semperi.2015.12.004. Epub 2016 Jan 14.
PubMed 26778236El-Khuffash A, McNamara PJ, Breatnach C, Bussmann N, Smith A, Feeney O, Tully E, Griffin J, de Boode WP, Cleary B, Franklin O, Dempsey E. The use of milrinone in neonates with persistent pulmonary hypertension of the newborn - a randomised controlled trial pilot study (MINT 1): study protocol and review of literature. Matern Health Neonatol Perinatol. 2018 Dec 3;4:24. doi: 10.1186/s40748-018-0093-1. eCollection 2018.
PubMed 30524749Uslu S, Kumtepe S, Bulbul A, Comert S, Bolat F, Nuhoglu A. A comparison of magnesium sulphate and sildenafil in the treatment of the newborns with persistent pulmonary hypertension: a randomized controlled trial. J Trop Pediatr. 2011 Aug;57(4):245-50. doi: 10.1093/tropej/fmq091. Epub 2010 Oct 4.
PubMed 20923790
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endovenous Sildenafil Early Management in Newborns Pulmonary Hypertension: a Clinical Trial
- ClinicalTrials.gov ID
- NCT04912726
- Acronym / sponsor ID
- HIPSEN / 234
- Conditions
- Hypertension, Pulmonary
- Keywords
- newborn, intravenous sildenafil, Hypertension, Pulmonary
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not begin due to lack of resources for its execution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad del NorteUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Jun 2021 (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.
Sildenafil is currently approved for the management of pulmonary hypertension of the newborn, with the availability of intravenous presentation it has been seen that the severity condition has already established, many times these patients do not have the adequate clinical response and there are no studies to date that evaluate the efficacy and safety of the same when it is started early in these patients, therefore we plan a randomized clinical trial to determine the efficacy and safety of the administration of intravenous sildenafil for early management of newborns with persistent pulmonary hypertension of the newborn.
Detailed description
Persistent pulmonary hypertension of the newborn is a relatively common condition that occurs in 2 to 7/1000 live births, being higher in term and late preterm newborns, representing up to 4% of all admissions in some units neonatal intensive care and that results in a mortality that ranges between 4 and 33% in the world. In the United States, its incidence varies between 0.4 and 6.8 per 1000 live births, while in the United Kingdom it is between 0.43 and 6 per 1000 live births. Although there has been an important development in the treatment of persistent pulmonary hypertension of the newborn in the last time, its impact on early neonatal mortality continues to be important, reaching approximately 10%. Currently there are no mortality data in underdeveloped countries and in Latin America. This considerable mortality is most likely a consequence of the fact that 40% of newborns are resistant to inhaled nitric oxide, which, together with supportive therapies, is the basis of treatment. Furthermore, the increasing cost of administering Nitric oxide to infants with pulmonary hypertension of the newborn reduces its availability in developing countries. On the other hand, extracorporeal membrane oxygenation is another therapeutic option that is currently being systematically evaluated in clinical trials, even so, it is not available in all units. Therefore, there was a real need to evaluate novel approaches for the management of the disease, being necessary to create therapeutic strategies that allow improving the prognosis of these newborns. Sildenafil is currently approved for the management of persistent pulmonary hypertension of the newborn, with the availability of intravenous presentation it has been seen that once the severity picture has been established, many times these patients do not have the adequate clinical response and there are no studies to date that evaluate the efficacy and safety of the same when started early in these patients.
Primary outcome: To assess the efficacy in decreasing estimated pulmonary artery pressure by 20% and improving survival with early use of intravenous sildenafil at a loading dose of 0.4 mg / kg in 3 hours, followed of continuous infusion at 1.6 mg / kg / day versus conventional treatment plus placebo in neonates with persistent pulmonary hypertension of the newborn.
Materials and methods:
A total of 44 newborns with a gestational age ≥ 34 weeks of age and less than 10 days old who were admitted to the Neonatal Intensive Care Unit, High Complexity Medicine with a diagnosis of persistent pulmonary hypertension of the newborn in absentia, were evaluated. of congenital heart disease or oxygenation index greater than 15, attended between May 2021 and May 2022 in the city of Barranquilla, 22 were divided into two groups for the control group and 22 for the intervention group. the intervention group received intravenous sildenafil loading dose of 0.4 mg / kg in 3 hours and continued in continuous infusion at 1.6 mg / kg / day (0.067 mg / kg / h). The control group will receive placebo at the same loading dose and infusion with 0.9% saline solution plus standard management under the unit protocol immediately after the echocardiographic diagnosis. The measure of the primary outcome was given by the decrease of 20% in the estimated pressure of the pulmonary artery by echocardiography at 24 hours after the start of treatment, at 48 hours, between 96 - 168 hours and 48 hours after the drug discontinuation.
Results and conclusions: ongoing.
Declaration of conflict of interest: The authors do not present any situation of real, potential or evident conflict of interest, including any financial or other interest.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Sildenafil Injectable ProductThe intervention group will receive intravenous sildenafil loading dose of 0.4 mg / kg in 3 hours and continue in continuous infusion at 1.6 mg / kg / day (0.067 mg / kg / h). |
| Placebo | No intervention | –The control group will receive placebo at the same loading dose and infusion with 0.9% saline solution plus standard management under the unit protocol immediately after the echocardiographic diagnosis. |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborns with gestational age ≥ 34 weeks and less than 10 days old, from the delivery room, joint accommodation, surgery at the Niño Jesus Hospital and referred from other institutions with an echocardiographic diagnosis of persistent pulmonary hypertension of the newborn. A diagnosis of persistent pulmonary hypertension of the newborn will be made if any of the following criteria are identified in the absence of cyanotic congenital heart disease by echocardiography: Tricuspid regurgitant jet with a pressure gradient ≥ 2/3 of systemic systolic blood pressure; intraventricular septum that flattens or slopes into the left ventricular cavity; bidirectional or right-to-left flow through patent ductus arteriosus; pulmonary artery acceleration time <40 milliseconds
Key exclusion criteria (3 listed)
- Congenital heart disease or fatal congenital anomalies
- Oxygenation Index (IO) > 15
- No parental consent
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 |
|---|---|---|
| Sildenafil Injectable ProductAlso: Intravenous sildenafilThe intervention group will receive intravenous sildenafil loading dose of 0.4 mg / kg in 3 hours and continue in continuous infusion at 1.6 mg / kg / day (0.067 mg / kg / h). | Drug | Intervention |
Primary outcome
20% decrease in estimated pulmonary artery pressure
Time frame: 7 days
Evaluate the efficacy in lowering the estimated pulmonary artery pressure by 20% and improved survival with early use of intravenous sildenafil at a loading dose of 0.4 mg / kg in 3 hours, followed by continuous infusion at 1.6 mg / kg / day versus conventional treatment plus placebo in neonates with persistent pulmonary hypertension of the newborn.
3 secondary outcomes
Duration of mechanical ventilation
Time frame: 7 days
Duration of inotropic therapy
Time frame: 7 days
Adverse events
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 32850518Martinho S, Adao R, Leite-Moreira AF, Bras-Silva C. Persistent Pulmonary Hypertension of the Newborn: Pathophysiological Mechanisms and Novel Therapeutic Approaches. Front Pediatr. 2020 Jul 24;8:342. doi: 10.3389/fped.2020.00342. eCollection 2020.
- Background: PubMed 25843770Jain A, McNamara PJ. Persistent pulmonary hypertension of the newborn: Advances in diagnosis and treatment. Semin Fetal Neonatal Med. 2015 Aug;20(4):262-71. doi: 10.1016/j.siny.2015.03.001. Epub 2015 Apr 2.
- Background: PubMed 28342684Fuloria M, Aschner JL. Persistent pulmonary hypertension of the newborn. Semin Fetal Neonatal Med. 2017 Aug;22(4):220-226. doi: 10.1016/j.siny.2017.03.004. Epub 2017 Mar 23.
- Background: PubMed 16585301Baquero H, Soliz A, Neira F, Venegas ME, Sola A. Oral sildenafil in infants with persistent pulmonary hypertension of the newborn: a pilot randomized blinded study. Pediatrics. 2006 Apr;117(4):1077-83. doi: 10.1542/peds.2005-0523.
- Background: PubMed 29855164Pedersen J, Hedegaard ER, Simonsen U, Kruger M, Infanger M, Grimm D. Current and Future Treatments for Persistent Pulmonary Hypertension in the Newborn. Basic Clin Pharmacol Toxicol. 2018 Oct;123(4):392-406. doi: 10.1111/bcpt.13051. Epub 2018 Jul 19.
- Background: PubMed 26778236Lakshminrusimha S, Mathew B, Leach CL. Pharmacologic strategies in neonatal pulmonary hypertension other than nitric oxide. Semin Perinatol. 2016 Apr;40(3):160-73. doi: 10.1053/j.semperi.2015.12.004. Epub 2016 Jan 14.
- Background: PubMed 30524749El-Khuffash A, McNamara PJ, Breatnach C, Bussmann N, Smith A, Feeney O, Tully E, Griffin J, de Boode WP, Cleary B, Franklin O, Dempsey E. The use of milrinone in neonates with persistent pulmonary hypertension of the newborn - a randomised controlled trial pilot study (MINT 1): study protocol and review of literature. Matern Health Neonatol Perinatol. 2018 Dec 3;4:24. doi: 10.1186/s40748-018-0093-1. eCollection 2018.
- Background: PubMed 20923790Uslu S, Kumtepe S, Bulbul A, Comert S, Bolat F, Nuhoglu A. A comparison of magnesium sulphate and sildenafil in the treatment of the newborns with persistent pulmonary hypertension: a randomized controlled trial. J Trop Pediatr. 2011 Aug;57(4):245-50. doi: 10.1093/tropej/fmq091. Epub 2010 Oct 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sildenafil Injectable Product in people with Hypertension, Pulmonary, run by Universidad del Norte.
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 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: withdrawn, as of the sponsor's last update on 6 Dec 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
20% decrease in estimated pulmonary artery pressure (time frame: 7 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 NCT04912726, which also lists 8 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 6 Dec 2024.