Persistent Fetal Circulation, Persistent Pulmonary Hypertension of the Newborn, PPHN
Conditions
Keywords
neonate, persistent fetal circulation, persistent pulmonary hypertension of the newborn, PPHN, Magnesium Sulfate, Nebulizer, hypoxia
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 50 mg/kg/hour) in treating mechanically ventilated neonates with severe persistent pulmonary hypertension of the newborn.
Interventions
Nebulized magnesium sulfate (isotonic solution) 256 mg every 15 minutes
Intravenous magnesium sulfate 200 mg/kg over 30 minutes, followed by a continuous infusion at a rate of 50 mg/kg/hour
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Each neonate was assigned a unique identification number. Pharmacy filled the active and placebo preparations in similar containers with sealed code for identification. Participants' families, treating clinicians, nurses, echocardiographers, and data collectors were unaware of group assignment and drug/placebo therapy.
Intervention model description
Two groups of neonates with PPHN 1. NebMag group: receive nebulized magnesium sulfate and intravenous placebo. 2. IVMag group: receive intravenous magnesium sulfate and nebulized placebo.
Eligibility
Sex/Gender
ALL
Age
6 Hours to 72 Hours
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation index (OI) | At baseline to 2, 6, 12, and 24 hours following study drug administration. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial blood pressure (MABP) | At baseline to 2, 6, 12, and 24 hours following study drug administration. | Changes in mean arterial blood pressure |
| Serum magnesium level | At baseline to 12 hours after study drug adminstration | Changes in serum magnesium level |
| Vasoactive Inotropic Score (VIS) | At baseline to 2, 6, 12, and 24 hours following study drug administration | 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) |
Countries
Egypt
Outcome results
None listed