Status:
COMPLETED
Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn
Lead Sponsor:
Sohag University
Conditions:
Persistent Fetal Circulation
Persistent Pulmonary Hypertension of the Newborn
Eligibility:
All Genders
6-72 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
The effectiveness and safety of nebulized magnesium sulfate (using isotonic solution in a dose of 1024 mg/hour) is compared with intravenous magnesium sulfate (200 mg/kg over 30 minutes, followed by 5...
Eligibility Criteria
Inclusion
- Newborns with PPHN fulfilling the following:
- 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
- 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.
- impaired kidney function.
- prior administration of pulmonary vasodilators.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04328636
Start Date
November 1 2017
End Date
August 1 2020
Last Update
August 18 2020
Active Locations (1)
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1
Neonatal Intensive Care Unit, Sohag University Hospital
Sohag, Egypt, 82524