NCT00000548

Brief Summary

To test the hypothesis that low-dose inhaled nitric oxide administered to preterm infants who continue to require mechanical ventilation at 14 days of age will reduce the incidence of chronic lung disease.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2000

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

First QC Date

October 27, 1999

Last Update Submit

March 3, 2015

Conditions

Bronchopulmonary DysplasiaLung Diseases

Outcome Measures

Primary Outcomes (1)

  • Survival without chronic lung disease (CLD)

    36 weeks

Interventions

mechanical ventilationPROCEDURE

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Preterm infants who are 500-1250 grams at birth and who require mechanical ventilation at 10 to 21 days of age. Exclusions include congenital heart disease or pulmonary abnormalities, including a patent ductus arteriosus, ventilation solely for apnea, small-for-gestational age, or clinical bleeding.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (5)

  • Ballard PL, Merrill JD, Godinez RI, Godinez MH, Truog WE, Ballard RA. Surfactant protein profile of pulmonary surfactant in premature infants. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1123-8. doi: 10.1164/rccm.200304-479OC. Epub 2003 Aug 6.

    PMID: 12904326BACKGROUND

  • Merrill JD, Ballard RA, Cnaan A, Hibbs AM, Godinez RI, Godinez MH, Truog WE, Ballard PL. Dysfunction of pulmonary surfactant in chronically ventilated premature infants. Pediatr Res. 2004 Dec;56(6):918-26. doi: 10.1203/01.PDR.0000145565.45490.D9. Epub 2004 Oct 20.

    PMID: 15496605BACKGROUND

  • Walsh MC, Hibbs AM, Martin CR, Cnaan A, Keller RL, Vittinghoff E, Martin RJ, Truog WE, Ballard PL, Zadell A, Wadlinger SR, Coburn CE, Ballard RA; NO CLD Study Group. Two-year neurodevelopmental outcomes of ventilated preterm infants treated with inhaled nitric oxide. J Pediatr. 2010 Apr;156(4):556-61.e1. doi: 10.1016/j.jpeds.2009.10.011. Epub 2010 Feb 6.

    PMID: 20138299DERIVED

  • Zupancic JA, Hibbs AM, Palermo L, Truog WE, Cnaan A, Black DM, Ballard PL, Wadlinger SR, Ballard RA; NO CLD Trial Group. Economic evaluation of inhaled nitric oxide in preterm infants undergoing mechanical ventilation. Pediatrics. 2009 Nov;124(5):1325-32. doi: 10.1542/peds.2008-3214. Epub 2009 Oct 19.

    PMID: 19841125DERIVED

  • Ballard RA, Truog WE, Cnaan A, Martin RJ, Ballard PL, Merrill JD, Walsh MC, Durand DJ, Mayock DE, Eichenwald EC, Null DR, Hudak ML, Puri AR, Golombek SG, Courtney SE, Stewart DL, Welty SE, Phibbs RH, Hibbs AM, Luan X, Wadlinger SR, Asselin JM, Coburn CE; NO CLD Study Group. Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. N Engl J Med. 2006 Jul 27;355(4):343-53. doi: 10.1056/NEJMoa061088.

    PMID: 16870913DERIVED

MeSH Terms

Conditions

Bronchopulmonary DysplasiaLung Diseases

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Roberta Ballard

    Children's Hospital of Philadelphia

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

March 1, 2000

Study Completion

February 1, 2006

Last Updated

March 5, 2015

Record last verified: 2015-03