CompletedPhase 1/2

Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn

Egypt28 participantsStarted 2017-11-01

Plain-language 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.

Who can participate

Age range6 Hours – 72 Hours

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Oxygenation index (OI)

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

Trial details

NCT IDNCT04328636

SponsorSohag University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-01

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