NCT01360671

Brief Summary

To determine the efficacy of iv sildenafil in term and near term infants with PPHN (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control group not treated with sildenafil.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

May 10, 2011

Last Update Submit

January 28, 2021

Conditions

Persistent Pulmonary Hypertension of the Newborn

Keywords

PPHNpersistent pulmonary hypertension of the newbornsildenafiliv

Outcome Measures

Primary Outcomes (2)

  • Efficacy - incidence of treatment failure

    Day 1-14

  • Need for inhaled nitric oxide or Extracorporeal membrane oxygenation

    Day 1-14

Secondary Outcomes (4)

  • Changes in oxygenation index

    6 & 12 hours

  • Changes in differential saturation

    6 & 12 hours

  • Duration of mechanical ventilation

    Days 1-14

  • Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation

    Days 1-14

Study Arms (1)

Sildenafil

EXPERIMENTAL

iv sildenafil

Drug: Sildenafil

Interventions

SildenafilDRUG

Loading dose of 0.1 mg/kg for 30 minutes followed by maintenance treatment of 0.03 mg/kg.h for up to 14 days

Sildenafil

Eligibility Criteria

AgeUp to 72 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Babies \< 72 hours old and at least 34 gestational weeks with PPHN or hypoxic respiratory failure associated with idiopathic PPHN, meconium aspiration, sepsis or pneumonia
  • Oxygenation index \>15 and \< 60

You may not qualify if:

  • Congenital anomaly
  • Large left to right intracardiac or ductal shunt
  • Already on inhaled nitric oxide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 26, 2011

Study Start

March 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

February 2, 2021

Record last verified: 2021-01