Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn (NCT04328636) | Clinical Trial Compass
CompletedPhase 1/2
Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn
Egypt28 participantsStarted 2017-11-01
Plain-language summary
The aim of this pilot randomized controlled blinded study is to evaluate the feasibility of using nebulized magnesium sulfate in the treatment of PPHN.
Who can participate
Age range
6 Hours – 72 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. born at ≥ 37 weeks gestational age.
. birth weight between 2.5 and 4 kg.
. post-natal age between 6 and 72 hours.
. connected to mechanical ventilation with an oxygenation index (OI) \> 30 on two occasions at least 15 minutes apart.
. documented PPHN confirmed by echocardiography.
Exclusion criteria
. failure to obtain informed consent.
. infants of mothers who received magnesium sulfate within 48 hours before labor.
. congenital heart diseases (other than PDA 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 inotrpic support.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oxygenation index (OI)
Timeframe: At baseline to 2, 6, 12, and 24 hours following study drug administration.