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Completed

NCT Number: NCT02244528

PK Study of Sildenafil in Neonate

The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used as treatment of pulmonary hypertension in neonate and preterm infant.

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Key information

Conditions

Neonates and Preterm Infants

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Admitted at NICU in Seoul National University Hospital or Bundang Seoul National University hospital
  • Infants who were diagnosed with PAH

Exclusion criteria

  • Severe allergic reaction to sildenafil
  • Inotropics for hypotension within 3 days prior to enrollment
  • AST or ALT > 3x ULN
  • Any condition that would make the participant, in the opinion of the investigator, unsuitable for the stud

Treatment and study plan

Sildenafil

Drug

Primary outcomes

  1. AUC(0-t)

    Time frame: t up to 5 weeks

    5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics

  2. Cmax(0-t)

    Time frame: t up to 5 weeks

    5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics

Secondary outcomes

  1. Change from baseline in pulmonary arterial hypertension at 5 weeks

    Time frame: pre, 2 weeks, 5 weeks of drug administration

    Echocardiography

    • RV systolic pressure: TR velocity2 x 4
    • Septum contour: normal, flat at end-systole, flat at end-diastole
    • LV shape: normal, partially D-shape, D-shape, squeezed
    • LV eccentricity index
    • RV area/LV area (Apical 4 chamber view, at end diastole)
    • RA enlargement (Apical 4 chamber view)
    • RV anterior wall thickness
    • TAPSE (Tricuspid annular plane systolic excursion)
    • RV Tei index (by tissue Doppler)
    • Tissue Doppler velocity at RV free wall

  2. respiratory severity score

    Time frame: pre, 2 weeks, 5 weeks after administration

    Mean airway pressure x FiO2

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

Pharmacokinetic Study of Sildenafil in Neonates and Preterm Infants

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 19, 2014
Registry last updated
Oct 16, 2017

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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