Phase 3
N=40
Treatment of Persistent Pulmonary Hypertension in Neonates With Nebulized Magnesium Sulfate
Magnesium Sulfate - PPHN
Bottom Line
View on ClinicalTrials.gov: NCT06603766 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Mean Airway Pressure (cm H2O) — 14.1; 13.8; 13.7; 13.25 (cm H2O) — p=0.83
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IV Magnesium Sulfate (Drug); Inhalational magnesium sulfate (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Benha University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Airway Pressure (cm H2O) |
14.1; 13.8; 13.7; 13.25; 14; 13.8 | 0.83 |
| PRIMARY Fraction of Inspired Oxygen (FiO2) (%) |
100; 100; 96.5; 97.5; 96; 97 | 0.46 |
| PRIMARY PaO2 (mmHg) |
38.45; 38.35; 54.8; 51.45; 69.45; 60.75 | 0.008 sig |
| PRIMARY Tracking Changes in the Oxygenation Index (OI) |
34.3; 34.1; 24.2; 25.1; 19.75; 22.1 | 0.032 sig |
| SECONDARY the Variations in Mean Arterial Blood Pressure (MABP) |
45.8; 45.7; 53.6; 48.6; 56.8; 53.6 | <0.001 sig |
| SECONDARY the Alterations in Serum Magnesium Levels (mmol/L) |
0.92; 0.93; 1.2; 3.6 | <0.001 sig |
Summary
we conducted this study to compare between effect of nebulized and intravenous magnesium sulfate (MgSO₄) for better treatment of persistent pulmonary hypertension of neonates with less side effects.
Eligibility Criteria
Inclusion Criteria
- Newborns with documented persistent pulmonary hypertension as confirmed by echocardiography.
- Neonates born at ≥ 35 wk. gestation with a birth weight of 2.5-4 kg
- Neonates have to be connected to mechanical ventilation with an oxygenation index (OI) >30 on two occasions at least 15 min apart.
- The echocardiogram had to show a predominant right-to-left or bidirectional shunt (through ductus arteriosus and/or foramen oval) and/or tricuspid regurgitant jet with a pressure gradient ≥ 2/3 of the systemic systolic blood pressure.
Exclusion Criteria
- Infants of parents who refuse to give informed consent.
- Infants of mothers who receive magnesium sulfate within 48 h before labor.
- Congenital heart diseases other than patent ductus arteriosus (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 vasoactive inotropes.
- Impaired kidney function; and prior administration of pulmonary vasodilators or prior administration of surfactant.
Data sourced from ClinicalTrials.gov (NCT06603766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.