Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152542
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : June 12, 2013
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Prematurity, Respiratory Distress Syndrome,Hypoxemia Drug: Inhaled nitric oxide Drug: Placebo Phase 3

Detailed Description:
Two questionnaires (truncated versions of previously validated surveys), one for parent and another for teacher, for which written consent was previously obtained are being sent to parents. The teacher questionnaires will be delivered via parents. A clinic visit will accompany age appropriate neurodevelopmental examination, administration of the Functional Independence Measure for Children (WeeFIM) survey, and hearing and visual screening exams (if appropriate).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Follow up at School-age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study
Study Start Date : May 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Arm Intervention/treatment
Experimental: Inhaled nitric oxide Drug: Inhaled nitric oxide
1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7
Placebo Comparator: Placebo Drug: Placebo
No iNO given for days 1-7

Primary Outcome Measures :
  1. Examine school-readiness at school-age in premature infants treated with iNO or placebo in the first week of life [ Time Frame: 4-7 years of age (between 2005-2006) ]

Secondary Outcome Measures :
  1. Examine health status at early school-age [ Time Frame: 4-7 years of age (between 2005-2006) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Children who participated in NOVA study but deceased post discharge

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 identifier (NCT number): NCT00152542

United States, Illinois
The University of Chicago, Comer Children's Hospital,
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Michael D Schreiber, M.D. University of Chicago

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Chicago Identifier: NCT00152542     History of Changes
Other Study ID Numbers: 9549 (temp19)
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: March 2009

Keywords provided by University of Chicago:
Inhaled nitric oxide,
Lung recruitment,
Ventilatory approach,
Neurodevelopmental outcomes,
School age children

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
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