Prolonged Outcomes After Nitric Oxide (PrONOx)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00234247
First received: October 4, 2005
Last updated: November 5, 2008
Last verified: November 2008

October 4, 2005
November 5, 2008
December 2002
November 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00234247 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prolonged Outcomes After Nitric Oxide (PrONOx)
Study of the Long-Term Outcomes of Nitric Oxide for Ventilated Premature Babies

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
  • Lung Diseases
  • Bronchopulmonary Dysplasia
  • Infant, Premature
  • Developmental Disabilities
  • Developmental Delay Disorders
Drug: Inhaled Nitric Oxide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
652
Not Provided
November 2008   (final data collection date for primary outcome measure)

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.
Both
up to 48 Hours
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00234247
R01 HL69991
Not Provided
Not Provided
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Derek C Angus, MD, MPH University of Pittsburgh
University of Pittsburgh
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP