Persistent Pulmonary Hypertension of the Newborn Clinical Trial
— NebMagOfficial title:
Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of The Newborn
Verified date | August 2020 |
Source | Sohag University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this pilot randomized controlled blinded study is to evaluate the feasibility of using nebulized magnesium sulfate in the treatment of PPHN.
Status | Completed |
Enrollment | 28 |
Est. completion date | August 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 72 Hours |
Eligibility |
Inclusion Criteria: Newborns with PPHN fulfilling the following: 1. born at = 37 weeks gestational age. 2. birth weight between 2.5 and 4 kg. 3. post-natal age between 6 and 72 hours. 4. connected to mechanical ventilation with an oxygenation index (OI) > 30 on two occasions at least 15 minutes apart. 5. documented PPHN confirmed by echocardiography. Exclusion Criteria: 1. failure to obtain informed consent. 2. infants of mothers who received magnesium sulfate within 48 hours before labor. 3. congenital heart diseases (other than PDA and foramen ovale). 4. major congenital anomalies (including congenital diaphragmatic hernia and lung hypoplasia). 5. prior need for cardiopulmonary resuscitation. 6. mean arterial blood pressure (MABP) < 35 mmHg despite therapy with volume infusions and inotrpic support. 7. impaired kidney function. 8. prior administration of pulmonary vasodilators. |
Country | Name | City | State |
---|---|---|---|
Egypt | Neonatal Intensive Care Unit, Sohag University Hospital | Sohag |
Lead Sponsor | Collaborator |
---|---|
Sohag University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxygenation index (OI) | Change in oxygenation index (OI) calculated by the classic formula: OI = [(FiO2 * MAP) / PaO2] FiO2 expressed in %; MAP in cmH2O/mmHg; and PaO2 in mmHg |
At baseline to 2, 6, 12, and 24 hours following study drug administration. | |
Secondary | Mean arterial blood pressure (MABP) | Changes in mean arterial blood pressure | At baseline to 2, 6, 12, and 24 hours following study drug administration. | |
Secondary | Serum magnesium level | Changes in serum magnesium level | At baseline to 12 hours after study drug adminstration | |
Secondary | Vasoactive Inotropic Score (VIS) | Changes in VIS calculated by the classic formula: VIS = dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 × epinephrine dose (µg/kg/min) + 100 × norepinephrine dose (µg/kg/min) + 10 × milrinone dose (µg/kg/min) + 10,000 × vasopressin dose (U/kg/min) |
At baseline to 2, 6, 12, and 24 hours following study drug administration |
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