Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

NCT04328636 | Completed Phase 1

• 1 other identifier: NebMag-PPHN Study
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean arterial blood pressure (MABP)

  At baseline to 2, 6, 12, and 24 hours following study drug administration.

• Serum magnesium level

  At baseline to 12 hours after study drug adminstration

• Vasoactive Inotropic Score (VIS)

  At baseline to 2, 6, 12, and 24 hours following study drug administration

Study Arms (2)

NebMag

EXPERIMENTAL

Neonates with PPHN receiving nebulized magnesium sulfate and intravenous placebo

Drug: Nebulized Magnesium Sulfate

IVMag

ACTIVE COMPARATOR

Neonates with PPHN receiving intravenous magnesium sulfate and nebulized placebo

Drug: Intravenous Magnesium Sulfate

Interventions

Nebulized Magnesium Sulfate DRUG

Nebulized magnesium sulfate (isotonic solution) 256 mg every 15 minutes

NebMag

Intravenous Magnesium Sulfate DRUG

Intravenous magnesium sulfate 200 mg/kg over 30 minutes, followed by a continuous infusion at a rate of 50 mg/kg/hour

IVMag

Eligibility Criteria

• Age: 6 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Neonatal Intensive Care Unit, Sohag University Hospital

Sohag, 82524, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33415555 DERIVED

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome; Hypoxia

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elsayed Abdelkreem, MD, PhD

  Faculty of Medicine, Sohag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: March 31, 2020
• Study Start: November 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

EG (1)