NCT01670136

Brief Summary

The purpose of this study is to learn more about the safety and dosing of sildenafil in infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2013

Typical duration for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

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

August 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

3.4 years

First QC Date

August 17, 2012

Last Update Submit

November 1, 2016

Conditions

Persistent Pulmonary Hypertension of the Newborn

Keywords

sildenafilpreterm infantspersistent pulmonary hypertension of the newborn

Outcome Measures

Primary Outcomes (5)

  • Area under the plasma concentration versus time curve 0-24 hours for sildenafil

    IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose

  • Peak plasma concentration of sildenafil

    IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose

  • Clearance of sildenafil

    IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose

  • Volume of distribution at steady state

    IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose

  • Half life of sildenafil

    IV study dose 0-15 min,1-2,3-4,12-14,24-30,48-56hr after flush.Clinical care: IV <0.5hr before dose <15 min & 3-4hr after flush <0.5hr before next dose. Enteral <0.5hr before dose, 1-2 & 3-4hr after dose, <0.5hr before next dose. 22-26hr after last dose

Secondary Outcomes (3)

  • Number of subjects with adverse events as a measure of safety and tolerability.

    From the time of the first dose to 3 days after the last dose; serious adverse events will be collected from the first dose of sildenafil to 7 days after the last dose of sildenafil

  • Correlation between serum and dried blood spot samples

    1-7 days

  • Evaluate P450 single nucleotide polymorphisms (SNPs)

    2-7 days

Study Arms (2)

sildenafil, standard of care

NO INTERVENTION

Infants receiving sildenafil as standard of care

sildenafil administered for study

OTHER

1 dose of sildenafil administered for study

Drug: 1 dose of sildenafil

Interventions

1 dose of sildenafilDRUG

A single IV dose of sildenafil will be administered over 90 minutes with no greater than a 15-minute flush. Final dose to be determined based on at least the first 4 participants enrolled in Cohort 1; final dose expected to be a single dose between 0.25 and 0.5 mg/kg.

Also known as: Revatio, Viagra
sildenafil administered for study

Eligibility Criteria

AgeUp to 364 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cohort 1:
  • Gestational age 28 weeks or less receiving sildenafil as standard of care \< 365 postnatal days
  • Cohort 2:
  • Gestational age 28 weeks or less
  • postnatal days of age
  • Mechanical ventilation or nasal continuous positive airway pressure (NCPAP) or high-flow nasal cannula
  • Intravenous line in place

You may not qualify if:

  • Cohort 1:
  • Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
  • Cohort 2:
  • Previous exposure to sildenafil within 7 days prior to enrollment
  • Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
  • History of allergic reactions to sildenafil
  • AST \> ULN or ALT \> 3x ULN
  • Currently on a vasopressor for hypotension
  • Known sickle cell disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35249-7335, United States

Location

Riley Hospital

Indianapolis, Indiana, 46202, United States

Location

Kosair Pediatric Research Unit

Louisville, Kentucky, 40202, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Kings County Hospital Center/SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Jackson W, Gonzalez D, Smith PB, Ambalavanan N, Atz AM, Sokol GM, Hornik CD, Stewart D, Mundakel G, Poindexter BB, Ahlfeld SK, Mills M, Cohen-Wolkowiez M, Martz K, Hornik CP, Laughon MM; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Safety of sildenafil in extremely premature infants: a phase I trial. J Perinatol. 2022 Jan;42(1):31-36. doi: 10.1038/s41372-021-01261-w. Epub 2021 Nov 5.

    PMID: 34741102DERIVED

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

  • Matthew M Laughon, MD, MPH

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2012

First Posted

August 21, 2012

Study Start

February 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(9)