Clinical trial NCT04328636: Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn
Official title: Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of The Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Persistent Fetal Circulation
Persistent Pulmonary Hypertension of the Newborn
PPHN
Keywords: neonate
persistent fetal circulation
persistent pulmonary hypertension of the newborn
PPHN
Magnesium Sulfate
Nebulizer
hypoxia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxygenation index (OI)
timeFrame: At baseline to 2, 6, 12, and 24 hours following study drug administration.
Secondary outcomes:
measure: Mean arterial blood pressure (MABP)
timeFrame: At baseline to 2, 6, 12, and 24 hours following study drug administration.
measure: Serum magnesium level
timeFrame: At baseline to 12 hours after study drug adminstration
measure: Vasoactive Inotropic Score (VIS)
timeFrame: At baseline to 2, 6, 12, and 24 hours following study drug administration
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Neonatal Intensive Care Unit, Sohag University Hospital
Study officials:
affiliation: Faculty of Medicine, Sohag University
name: Elsayed Abdelkreem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdelkreem E, Mahmoud SM, Aboelez MO, Abd El Aal M. Nebulized Magnesium Sulfate for Treatment of Persistent Pulmonary Hypertension of Newborn: A Pilot Randomized Controlled Trial. Indian J Pediatr. 2021 Aug;88(8):771-777. doi: 10.1007/s12098-020-03643-y. Epub 2021 Jan 8.