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Completed

NCT Number: NCT04391478

Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension

Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.

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Key information

Conditions

Persistent Pulmonary Hypertension

Age range

1 hour–10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

40 neonates with PPHN, met inclusion criteria, randomly assigned to 2 groups, each includes 20, first group received intravenous milrinone and second group received nasogastric sildenafil. both groups receive other supportive care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • gestational age >34 weeks
  • postnatal age <10 days

Exclusion criteria

  • neonates with congenital heart disease
  • neonates with congenital diaphragmatic hernia

Treatment and study plan

Milrinone

Drug

milrinone lactate, 1mg/ml, for intra venous use only

Other names: primacor

Sildenafil

Drug

50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube

Other names: Viagra

Primary outcomes

  1. efficacy of milrinone versus sildenafil in treatment of PPHN

    Time frame: 6 - 12 months

    effect on oxygenation index

Secondary outcomes

  1. final outcome

    Time frame: 6 - 12 months

    Mortality

  2. Bleeding

    Time frame: 6-12 months

    Bleeding (e.g pulmonary hemorrhage) that is believed to be attributed to medication

  3. Ventilation

    Time frame: 6-12 months

    total duration of mechanical ventilation

  4. Ventilatory settings

    Time frame: 6-12 months

    highest ventilator settings

Sponsors and collaborators

Lead sponsor

Rania Ali El-Farrash

Other

Registry information

Official study title

Milrinone Versus Sildenafil in Treatment of PPHN in Neonates

Acronym: ESMPPHTN

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 18, 2020
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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