NCT00152542

Brief Summary

Our previous data demonstrated that premature infants treated with inhaled nitric oxide at birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to determine whether this benefit continues through school age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

June 12, 2013

Status Verified

March 1, 2009

Enrollment Period

1.3 years

First QC Date

September 8, 2005

Last Update Submit

June 11, 2013

Conditions

Prematurity, Respiratory Distress Syndrome,Hypoxemia

Keywords

Inhaled nitric oxide,Lung recruitment,Ventilatory approach,Neurodevelopmental outcomes,School age children

Outcome Measures

Primary Outcomes (1)

  • Examine school-readiness at school-age in premature infants treated with iNO or placebo in the first week of life

    4-7 years of age (between 2005-2006)

Secondary Outcomes (1)

  • Examine health status at early school-age

    4-7 years of age (between 2005-2006)

Study Arms (2)

Inhaled nitric oxide

EXPERIMENTAL
Drug: Inhaled nitric oxide

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Inhaled nitric oxideDRUG

1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7

Inhaled nitric oxide
PlaceboDRUG

No iNO given for days 1-7

Placebo

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who participated in NOVA study and are of school age

You may not qualify if:

  • Children who participated in NOVA study but deceased post discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago, Comer Children's Hospital,

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Patrianakos-Hoobler AI, Marks JD, Msall ME, Huo D, Schreiber MD. Safety and efficacy of inhaled nitric oxide treatment for premature infants with respiratory distress syndrome: follow-up evaluation at early school age. Acta Paediatr. 2011 Apr;100(4):524-8. doi: 10.1111/j.1651-2227.2010.02077.x. Epub 2010 Dec 1.

    PMID: 21054515DERIVED

MeSH Terms

Conditions

Premature BirthRespiratory Distress SyndromeHypoxia

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael D Schreiber, M.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

May 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

June 12, 2013

Record last verified: 2009-03

Locations

US(1)