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New treatment option for Persistent Pulmonary Hypertension of Newborn
Official title Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn
ClinicalTrials.gov ID: NCT04898114
What this study is testing
What is Magnesium sulfate?
Magnesium sulfate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for persistent pulmonary hypertension of newborn.
Also referred to as MgSO4.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 72
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sohag, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 hours to 72 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sohag, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.