NCT04898114 Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
| NCT ID | NCT04898114 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sohag University |
| Condition | Persistent Pulmonary Hypertension of Newborn |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-06-02 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2021-06-02 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Impaired kidney function. * Prior administration of pulmonary vasodilators. * Gastrointestinal intolerance or bleeding
Contact & Investigator
Elsayed Abdelkreem, MD, PhD
PRINCIPAL INVESTIGATOR
Sohag University
Frequently Asked Questions
Who can join the NCT04898114 clinical trial?
This trial is open to participants of all sexes, aged 6 Hours or older, up to 72 Hours, studying Persistent Pulmonary Hypertension of Newborn. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04898114 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04898114 currently recruiting?
Yes, NCT04898114 is actively recruiting participants. Contact the research team at d.elsayedmohammed@med.sohag.edu.eg for enrollment information.
Where is the NCT04898114 trial being conducted?
This trial is being conducted at Sohag, Egypt.
Who is sponsoring the NCT04898114 clinical trial?
NCT04898114 is sponsored by Sohag University. The principal investigator is Elsayed Abdelkreem, MD, PhD at Sohag University. The trial plans to enroll 40 participants.