NCT00234247

Brief Summary

The purpose of this study is to look at the long term consequences of prematurity in infants treated with inhaled nitric oxide (iNO) while in the neonatal intensive care unit.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
652

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2002

Longer than P75 for all trials

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

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

5.9 years

First QC Date

October 4, 2005

Last Update Submit

May 12, 2016

Conditions

Lung DiseasesBronchopulmonary DysplasiaPremature BirthDevelopmental DisabilitiesDevelopmental Delay Disorders

Outcome Measures

Primary Outcomes (1)

  • Assess the cost-effectiveness of iNO in ventilated premature infants using: long term clinical and childhood developmental outcomes; family impact; and healthcare costs of prematurity-associated respiratory failure

    Five Years

Interventions

Long Term Follow-UpOTHER

Extended and enhance the follow-up of the NHLBI iNO RCT by assessing the effects of iNO use on: 1.) long term clinical and childhood developmental outcomes; 2.) family impact, and; 3.) healthcare costs of prematurity-associated respiratory failure.

Eligibility Criteria

AgeUp to 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Neonatal intensive care patients - those with prematurity-associated respiratory failure following modern management.

You may qualify if:

  • Enrolled in "Inhaled NO for the Prevention of Chronic Lung Disease" trial (ClinicalTrials.gov Identifier: NCT00006401).

You may not qualify if:

  • Did not consent to extended follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Lung DiseasesBronchopulmonary DysplasiaPremature BirthDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesVentilator-Induced Lung InjuryLung InjuryInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Derek C Angus, MD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Critical Care Medicine

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 6, 2005

Study Start

December 1, 2002

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

May 13, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share