NCT01558466|UnknownPhase 3
Sildenofil in Persistent Pulmonary Hypertension in Newborns
Sildeno
Early Combined Use of Inhaled Nitric Oxide and Oral Sildenafil on the Outcome of Pulmonary Hypertension in New Born Infants
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Sildeno
Early Combined Use of Inhaled Nitric Oxide and Oral Sildenafil on the Outcome of Pulmonary Hypertension in New Born Infants
Sponsor study identifier
interventional
100
1 country
1
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study hopes to evaluate the effectiveness of early combined use of Sildenafil and nitric oxide (iNO) in newborns with Persistent pulmonary hypertension (PPHN) and or hypoxemic respiratory failure and assess whether this would improve oxygenation, improve time on mechanical ventilation for these babies and also prevent rebound hypoxic episodes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 11, 2012
Actual (reported)March 20, 2012
Actual (reported)November 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Oxygen index
OI= PaO2 X FiO2/100( Absolute values and change from baseline measurement after first dose, measured every 6 hours for 7 days while on therapy. Improvement in OI is defined as decrease in OI of 20% from the previously calculated value.
7 days after birth and admission to the NICU
A-a gradient
Alveolar arterial oxygen difference gradient
7 days after admission to the NICU
Hemodynamic parameters
Hemodynamic parameters ( absolute values and change from baseline measured after the first dose, after 24 hours, after 36 hours, and after 48 hours and every 12 hours thereafter for a total of 7 days while receiving therapy and 7 days after the end of treatment including : 1\. Heart rate, mean blood pressure, respiratory rate, oxygen saturation and blood gas b. Pulmonary arterial pressure in mm Hg measured by echocardiography c. cArdiac output in liter/kg/min d. Oxygenation ( PaO2) and FiO2 requirement
7 days
Days of hospitalization
7 days after admission to the NICU
mortality
28 days of life
iNO combined with placebo will be administered
iNO combined with Sildenafil
50 mg tablet will be thoroughly crushed into powder form and diluted in 10 ml ora base suspension syrup agent and a dilution will be performed to prepare 5 mg/ml. All doses required for 48 hours will be available; solutions will be stored at 2-8 degrees C where solution should be stable for at least a month.
Women's hospital, NICU
Doha, Qatar, 00974, Qatar
Husam Salama, MD
Hamad Medical Corporation, Doha, Qatar
First Submitted
March 11, 2012
First Posted
March 20, 2012
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
The placebo will have an equal volume of diluent - Orabase syrup of the same colour and viscosity as the active comparator. Infants in this group will receive normal saline as placebo every 6 hours
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 25, 2012
Record last verified: 2012-09
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Source: ClinicalTrials.gov.
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