Status:
COMPLETED
Treatment of Persistent Pulmonary Hypertension in Neonates With Nebulized Magnesium Sulfate
Lead Sponsor:
Benha University
Conditions:
Magnesium Sulfate - PPHN
Eligibility:
All Genders
1-3 years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
Persistent pulmonary hypertension of the newborn (PPHN) is a serious syndrome characterized by sustained fetal elevation of pulmonary vascular resistance (PVR) at birth. The syndrome is seen in two of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06603766
Start Date
October 1 2021
End Date
September 28 2023
Last Update
February 5 2025
Active Locations (1)
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1
Pediatrics Department, Faculty of Medicine, Benha University.
Benha, Egypt., Egypt