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Prolonged Outcomes After Nitric Oxide (PrONOx)

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ClinicalTrials.gov Identifier: NCT00234247
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Lung Diseases Bronchopulmonary Dysplasia Premature Birth Developmental Disabilities Developmental Delay Disorders Other: Long Term Follow-Up Phase 3

Detailed Description:

Prematurity-associated respiratory failure is a growing public health problem. Although mortality has dropped with advances in perinatal care, this condition consumes considerable healthcare resources and is increasingly associated with worrisome long-term morbidity, developmental delay, and family burden. Inhaled nitric oxide (iNO), a selective pulmonary vasodilator that improves short-term outcomes in term neonates with respiratory failure, may benefit premature infants. Consequently, a NHLBI-funded randomized controlled trial (iNO RCT- NHLBI U01 HL064857) is assessing the effect of iNO on the combined end-point of mortality or oxygen dependency at 36 weeks post conceptional age in 800 infants with prematurity-associated respiratory failure.

However, prematurity-associated respiratory failure has a different etiology from respiratory failure in term infants and the wide array of long-term consequences that may be affected by iNO are not captured under the existing study design.

We therefore are extending and enhance the follow-up of the NHLBI iNO RCT. Specifically, we are assessing the effects of INO use on: #1. - long-term clinical and childhood developmental outcomes; #2. - family burden, and; #3. - healthcare costs of prematurity-associated respiratory failure. Under aim #4, we will use data from aims #1-3 to assess the cost-effectiveness of iNO in ventilated premature infants.

We are achieving these aims by augmenting the NHLBI iNO RCT data collection with: i.) survival follow-up for an average of 4 1/2 years; ii.) comprehensive, standardized follow-up clinic visits at 1, 2, 3 and 4 1/2 years to assess clinical outcomes, childhood development, and family burden; iii.) structured telephone interviews with parents every 3 months in year 1 and every 6 months thereafter for an average of 4½ years to assess chronic morbidity and post-discharge healthcare use; iv.) collection of detailed hospital bills for the primary hospitalization, and; v.) a comprehensive analysis plan.

This study will allow us to determine the long-term consequences of iNO therapy in this condition, aiding clinicians, families, and policymakers and immediately affecting care of critically ill infants. By combining with the NHLBI iNO RCT, we take advantage of an important opportunity to gather prospective long-term outcome data in a randomized fashion. Our proposal will significantly increase the return on investment in the RCT through a greater understanding of the impact of iNO therapy from a societal perspective. Neonatal intensive care has changed dramatically in the last ten years. This study will also provide contemporary information on the long-term outcomes of prematurity-associated respiratory failure following modern management. Finally, our data will allow assessment of the robustness of early proxies for subsequent outcomes, key for future study design in this area.

Study Design

Study Type : Observational
Actual Enrollment : 652 participants
Time Perspective: Prospective
Official Title: Study of the Long-term Outcomes of Nitric Oxide for Ventilated Premature Babies
Study Start Date : December 2002
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Other: Long Term Follow-Up
    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.

Outcome Measures

Primary Outcome Measures :
  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 [ Time Frame: Five Years ]

Eligibility Criteria

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Neonatal intensive care patients - those with prematurity-associated respiratory failure following modern management.

Inclusion Criteria:

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

Exclusion Criteria:

  • Did not consent to extended follow-up.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234247

Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Derek C Angus, MD, MPH University of Pittsburgh
More Information

Additional Information:
Responsible Party: Derek C. Angus, MD, MPH, Chair, Critical Care Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00234247     History of Changes
Other Study ID Numbers: R01HL069991 ( U.S. NIH Grant/Contract )
1U01HL064857-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Developmental Disabilities
Premature Birth
Lung Diseases
Bronchopulmonary Dysplasia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Neurodevelopmental Disorders
Mental Disorders
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents