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Nebulized Magnesium Sulfate and Sildenafil for Persistent Pulmonary Hypertension of Newborn

ConditionPersistent Pulmonary Hypertension of Newborn
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-72
SponsorSohag University

About this trial

The aim of this study is to evaluate the effectiveness of nebulized magnesium sulfate combined with sildenafil citrate, compared with sildenafil citrate alone, in treating neonates with severe persistent pulmonary hypertension on mechanical ventilation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gestational age ≥ 36 weeks

Birth weight between 2.5 and 4 kg.

Post-natal age between 6 and 72 hours.

PPHN confirmed by echocardiography

Disqualifiers

Failure to obtain informed consent

Newborns to mothers who received magnesium sulfate within 48 hours before labor.

Congenital heart diseases, other than patent ductus arteriosus and foramen ovale.

Major congenital anomalies (including congenital diaphragmatic hernia and lung hypoplasia).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magnesium sulfate

    Drug

    Nebulized magnesium sulfate (4 ml of 6.4% solution) every 15 minutes

  • Sildenafil Citrate

    Drug

    Oral sildenafil citrate at an initial dose of 1 mg/kg, with incremental increases by 0.5 mg/kg every 6 hours till reaching a target dose of 2mg/kg every 6 hours.

  • Isotonic saline

    Other intervention

    Nebulized isotonic saline (4 ml) every 15 minutes

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: NebMagExperimental treatment 2 interventions
Group B: ControlPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in Oxygenation index (OI)

OI will be calculated using the following formula: OI = \[(FiO2 × MAP) / PaO2\] (FiO2, fraction of inspired oxygen expressed in %; MAP, mean airway pressure in cmH2O/mmHg; and PaO2, partial pressure of arterial oxygen in mmHg).

Time frame
From baseline to 2, 6, 12, and 24 hours following study drug administration

Secondary outcomes

1

Change in Mean arterial blood pressure (MABP)

Time frame
From baseline to 2, 6, 12, and 24 hours following study drug administration.
2

Change in Vasoactive Inotropic Score (VIS)

The VIS will be calculated using the following 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).

Time frame
From baseline to 2, 6, 12, and 24 hours following study drug administration.
3

Change in Pulmonary artery systolic pressure (PASP)

PASP will be estimated by echocardiography using the modified Bernoulli equation: PASP = (TRJV2 × 4) + RAP (TRJV, tricuspid regurgitation jet velocity; RAP, right atrial pressure).

Time frame
From baseline to 24 hours after study drug administration
4

Change in Serum magnesium level

Time frame
From baseline to 24 hours after study drug administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sohag University

Lead sponsor

Source ClinicalTrials.gov
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