NCT00139217

Brief Summary

The primary objective of the trial is to determine the feasibility and clinical safety and efficacy of non-invasive inhaled nitric oxide in infants with PPHN without significant pulmonary +-parenchymal disease who would normally receive inhaled nitric oxide only after placement of a tracheal tube and the institution of mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2005

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

2.1 years

First QC Date

August 29, 2005

Last Update Submit

May 27, 2014

Conditions

Pulmonary Hypertension

Keywords

Persistent pulmonary hypertensionNon-invasive inhaled nitric oxideiNO

Outcome Measures

Primary Outcomes (1)

  • % subjects assigned to non-invasive iNO who do not require intubation and mechanical ventilation

Interventions

iNODRUG
Non-invasive nitric oxidePROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Newborn infants \>/= 34 weeks with clinical or echocardiographic evidence of PPHN with a PaO2 \< 100 of Fio2 0.8 who are not mechanically ventilated

You may not qualify if:

  • Infants with significant lung disease
  • Inability to sustain spontaneous respirations
  • Lethal congenital anomalies
  • Severe birth asphyxia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University affiliated newborn intensive care units

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Golde Dudell, M.D.

    Emory University, Department of Pediatrics, Division of Neonatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

August 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

US(1)