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Persistent Pulmonary Hypertension of NewbornPhase 1/2NCT04898114

Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

A Phase 1/2 study testing Magnesium sulfate, Sildenafil Citrate and Isotonic saline in people with Persistent Pulmonary Hypertension of Newborn, run by Sohag University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe persistent pulmonary hypertension on mechanical ventilation. Read more about this study

Who is it for?
Ages 6 to 72 hours
What is being tested?
Magnesium sulfate, Sildenafil Citrate and Isotonic saline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteEgypt
Study dates
2 Jun 2021to 1 Jun 2025
Phase
Phase 1/2
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 6 to 72 hours
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Gestational age ≥ 36 weeks
  • Birth weight between 2.5 and 4 kg.
  • Post-natal age between 6 and 72 hours.
  • PPHN confirmed by echocardiography
  • Oxygenation index (OI) > 30 on two occasions at least 15 minutes apart
  • Connected to Mechanical Ventilation

Who cannot join

  • Failure to obtain informed consent
  • Newborns to mothers who received magnesium sulfate within 48 hours before labor.
  • Congenital heart diseases, other than patent ductus arteriosus and foramen ovale.
  • Major congenital anomalies (including congenital diaphragmatic hernia and lung hypoplasia).
  • Prior need for cardiopulmonary resuscitation.
  • Mean arterial blood pressure (MABP) < 35 mmHg despite therapy with volume infusions and vasoactive inotropes.
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  • Impaired kidney function.
  • Prior administration of pulmonary vasodilators.
  • Gastrointestinal intolerance or bleeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elsayed Abdelkreem, MD, PhD contact

00201114232126

d.elsayedmohammed@med.sohag.edu.eg

Egypt1 site, 1 recruiting

  • Neonatal Intensive Care Unit, Sohag University Hospital

    Sohag, 82524

    Mostafa Abo-Sidera, MD, PhD, 1002028668 ext. 0020, aabosdera@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: Effectiveness of Nebulized Magnesium Sulfate Combined With Sildenafil Citrate in Persistent Pulmonary Hypertension of Newborn

The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe persistent pulmonary hypertension on mechanical ventilation.

Read the detailed description

Persistent pulmonary hypertension of newborn (PPHN) is a serious condition that results from failure of the normal postnatal circulatory transition and is associated with significant mortality and morbidity. Advanced medical treatment, such as inhaled nitric oxide (iNO), high-frequency ventilation (HFV), and extracorporeal membrane oxygenation (ECMO) are commonly not available in developing countries. Intravenous magnesium sulfate has been shown to alleviate pulmonary hypertension but is associated with systemic hypotension and is less effective compared with iNO and sildenafil. Nebulized magnesium sulfate has been reported to be more effective and safer compared with intravenous magnesium sulfate in treating neonates with PPHN on mechanical ventilation. Combined nebulized magnesium and sildenafil has been studied in a small trial on spontaneously breathing neonates with PPHN but not on those connected to mechanical ventilation.

The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe PPHN on mechanical ventilation. We hypothesize that neonates with severe PPHN connected to mechanical ventilation could benefit from taking continuous nebulization of magnesium sulfate combined besides sildenafil.

Being tested
Magnesium sulfate, Sildenafil Citrate, Isotonic saline
Keywords
neonate, persistent fetal circulation, persistent pulmonary hypertension of the newborn, PPHN, Magnesium Sulfate, Nebulizer, hypoxia, mechanical ventilation
Medical subject headings
Persistent Fetal Circulation Syndrome, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium sulfateDrug

    Also called MgSO4

    Nebulized magnesium sulfate (4 ml of 6.4% solution) every 15 minutes

  • Sildenafil CitrateDrug

    Also called Viagra

    Oral sildenafil citrate at an initial dose of 1 mg/kg, with incremental increases by 0.5 mg/kg every 6 hours till reaching a target dose of 2mg/kg every 6 hours.

  • Isotonic salineOther

    Also called 0.9% NaCl

    Nebulized isotonic saline (4 ml) every 15 minutes

Study groups in NCT04898114
Study groupRoleWhat they receive
NebMagExperimentalNebulized magnesium sulfate and oral sildenafil
Receives: Drug: Magnesium sulfate; Drug: Sildenafil Citrate
ControlPlacebo comparatorNebulized placebo (isotonic saline) and oral sildenafil
Receives: Drug: Sildenafil Citrate; Other: Isotonic saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Oxygenation index (OI)

    OI will be calculated using the following formula: OI = [(FiO2 × MAP) / PaO2] (FiO2, fraction of inspired oxygen expressed in %; MAP, mean airway pressure in cmH2O/mmHg; and PaO2, partial pressure of arterial oxygen in mmHg).

    Measured: From baseline to 2, 6, 12, and 24 hours following study drug administration

Secondary outcomes (4)

  1. Change in Mean arterial blood pressure (MABP)

    Measured: From baseline to 2, 6, 12, and 24 hours following study drug administration.

  2. Change in Vasoactive Inotropic Score (VIS)

    The VIS will be calculated using the following formula: VIS = dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 × epinephrine dose (µg/kg/min) + 100 × norepinephrine dose (µg/kg/min) + 10 × milrinone dose (µg/kg/min) + 10,000 × vasopressin dose (U/kg/min).

    Measured: From baseline to 2, 6, 12, and 24 hours following study drug administration.

  3. Change in Pulmonary artery systolic pressure (PASP)

    PASP will be estimated by echocardiography using the modified Bernoulli equation: PASP = (TRJV2 × 4) + RAP (TRJV, tricuspid regurgitation jet velocity; RAP, right atrial pressure).

    Measured: From baseline to 24 hours after study drug administration

  4. Change in Serum magnesium level

    Measured: From baseline to 24 hours after study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2021
  2. Study start2 Jun 2021
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups of neonates with PPHN on mechanical ventilation: (1) NebMag group: receive nebulized magnesium sulfate and oral sildenafil citrate; (2) Control group: receive nebulized placebo (isotonic saline) and oral sildenafil citrate.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04898114
Sponsor's protocol ID
Neb-Mag-2
Status last verified
Nov 2024
First submitted
20 May 2021
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Unidentified individual participant data will be available from the principal investigator upon reasonable request

Publications

  • Abdelkreem E, Mahmoud SM, Aboelez MO, Abd El Aal M. Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of Newborn: A Pilot Randomized Controlled Trial. Indian J Pediatr. 2021 Aug;88(8):771-777. doi: 10.1007/s12098-020-03643-y. Epub 2021 Jan 8.

    PubMed 33415555

  • Mandell E, Kinsella JP, Abman SH. Persistent pulmonary hypertension of the newborn. Pediatr Pulmonol. 2021 Mar;56(3):661-669. doi: 10.1002/ppul.25073.

    PubMed 32930508

  • El-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 30524749

  • Lai MY, Chu SM, Lakshminrusimha S, Lin HC. Beyond the inhaled nitric oxide in persistent pulmonary hypertension of the newborn. Pediatr Neonatol. 2018 Feb;59(1):15-23. doi: 10.1016/j.pedneo.2016.09.011. Epub 2017 Aug 10.

    PubMed 28923474

  • Nakwan N. The Practical Challenges of Diagnosis and Treatment Options in Persistent Pulmonary Hypertension of the Newborn: A Developing Country's Perspective. Am J Perinatol. 2018 Dec;35(14):1366-1375. doi: 10.1055/s-0038-1660462. Epub 2018 Jun 19.

    PubMed 29920641

  • He Z, Zhu S, Zhou K, Jin Y, He L, Xu W, Lao C, Liu G, Han S. Sildenafil for pulmonary hypertension in neonates: An updated systematic review and meta-analysis. Pediatr Pulmonol. 2021 Aug;56(8):2399-2412. doi: 10.1002/ppul.25444. Epub 2021 May 13.

    PubMed 33983650

  • Ho JJ, Rasa G. Magnesium sulfate for persistent pulmonary hypertension of the newborn. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD005588. doi: 10.1002/14651858.CD005588.pub2.

    PubMed 17636807

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Magnesium sulfate, Sildenafil Citrate and Isotonic saline in people with Persistent Pulmonary Hypertension of Newborn, run by Sohag 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 27 Nov 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 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Elsayed Abdelkreem, MD, PhD (00201114232126, d.elsayedmohammed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Oxygenation index (OI) (time frame: From baseline to 2, 6, 12, and 24 hours following study drug administration). 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 NCT04898114, which also lists 7 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 27 Nov 2024.

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