NCT01558466

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

3 years

First QC Date

March 11, 2012

Last Update Submit

September 23, 2012

Conditions

Persistent Fetal Circulation Syndrome

Keywords

newbornINOSildenafilPPHN

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • Days of hospitalization

    7 days after admission to the NICU

  • mortality

    28 days of life

Study Arms (2)

Group A - Placebo

PLACEBO COMPARATOR

iNO combined with placebo will be administered

Drug: diluent

Group B- Sildenafil

ACTIVE COMPARATOR

iNO combined with Sildenafil

Drug: Sildenafil

Interventions

SildenafilDRUG

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.

Also known as: Viagra
Group B- Sildenafil
diluentDRUG

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

Also known as: Normal saline
Group A - Placebo

Eligibility Criteria

Age36 Weeks - 41 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newborn infants of post natal age less than 48 hours
  • Gestational age equal to or more than 34 weeks
  • Oxygen index of more than or equal to 20 (moderately ill infants)
  • Radiological, clinical and biochemical evidence of acute hypoxic respiratory failure
  • Surfactant therapy has been established when indicated
  • Presence of arterial line

You may not qualify if:

  • Congenital diaphragmatic hernia
  • Major congenital abnormalities
  • Significant congenital heart disease
  • Cyanotic congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's hospital, NICU

Doha, Qatar, 00974, Qatar

RECRUITING

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Interventions

Sildenafil CitrateSaline Solution

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-RingCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Husam Salama, MD

    Hamad Medical Corporation, Doha, Qatar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Husam Em Salama, MRCP

CONTACT

00974- 55262159hsalama1@hmc.org.qa

Ahmed Masoud, MD

CONTACT

00974-55112369amasoud@hmc.org.qa

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2012

First Posted

March 20, 2012

Study Start

November 1, 2011

Primary Completion

November 1, 2014

Study Completion

June 1, 2015

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

QA(1)