Prolonged Outcomes After Nitric Oxide (PrONOx)

Brief Title

Prolonged Outcomes After Nitric Oxide (PrONOx)

Official Title

Study of the Long-term Outcomes of Nitric Oxide for Ventilated Premature Babies

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.

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 Type

Observational

Primary Outcome

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

Condition

Lung Diseases

Intervention

Long Term Follow-Up

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

Start Date

December 2002

Completion Date

November 2008

Primary Completion Date

November 2008

Eligibility Criteria

        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.

Gender

All

Ages

N/A - 48 Hours

Accepts Healthy Volunteers

No

Contacts

Derek C Angus, MD, MPH, ,

Administrative Informations

NCT ID

NCT00234247

Organization ID

R01HL069991

Secondary IDs

1U01HL064857-01A1

Responsible Party

Principal Investigator

Study Sponsor

University of Pittsburgh

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Derek C Angus, MD, MPH, Principal Investigator, University of Pittsburgh

Verification Date

May 2016