Trial Outcomes & Findings for Study of Sildenafil to Treat Newborns With Persistent Pulmonary Hypertension (NCT NCT01409031)

NCT ID: NCT01409031

Last Updated: 2019-02-01

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

From baseline values at 4 and 24 hours

Results posted on

2019-02-01

Participant Flow

This trial was terminated early due to lack of recruitment.

Participant milestones

Participant milestones
Measure	Intravenous Sildenafil Intravenous Sildenafil: 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.	Placebo 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days. Placebo: An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
Overall Study STARTED	1	2
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Intravenous Sildenafil Intravenous Sildenafil: 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.	Placebo 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days. Placebo: An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
Overall Study transferred to other hosp	1	0

Baseline Characteristics

Study of Sildenafil to Treat Newborns With Persistent Pulmonary Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Sildenafil n=1 Participants Intravenous Sildenafil: 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.	Placebo n=2 Participants 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days. Placebo: An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.	Total n=3 Participants Total of all reporting groups
Age, Customized <=1 days old	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline values at 4 and 24 hours

Population: This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 7-day treatment period

Population: This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.

Receipt of standard therapy (inhaled nitric oxide \[iNO\] and/or extracorporeal membrane oxygenation \[ECMO\]) at any point during the 7-day treatment period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 4 hours post study drug administration

Population: This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.

Change in pulmonary arterial pressure as calculated by echocardiography

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be on supplemental O2 an average of 2 weeks

Population: This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Population: This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be on mechanical ventilation an average of 1 week

Population: This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.

Outcome measures

Outcome data not reported

Adverse Events

Intravenous Sildenafil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intravenous Sildenafil n=1 participants at risk Intravenous Sildenafil: 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.	Placebo n=2 participants at risk 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days. Placebo: An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
Respiratory, thoracic and mediastinal disorders PaO2 < 40	0.00% 0/1	50.0% 1/2 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

John Kinsella, MD

University of Colorado, Denver

Phone: 303-724-2853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place