Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Hours - 72 Hours
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04898114
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sohag University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Elsayed Abdelkreem, MD, PhD
Principal Investigator Affiliation	Sohag University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Egypt
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Persistent Pulmonary Hypertension of Newborn

Additional Details

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.

Arms & Interventions

Arms

Experimental: NebMag

Nebulized magnesium sulfate and oral sildenafil

Placebo Comparator: Control

Nebulized placebo (isotonic saline) and oral sildenafil

Interventions

Drug: - Magnesium sulfate

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

Drug: - Sildenafil Citrate

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.

Other: - Isotonic saline

Nebulized isotonic saline (4 ml) every 15 minutes

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