Follow-up at School-Age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants
This study has been completed.
Sponsor:
University of Chicago
Collaborator:
INO Therapeutics
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00152542
First received: September 8, 2005
Last updated: March 6, 2009
Last verified: March 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prematurity, Respiratory Distress Syndrome,Hypoxemia |
Drug: Inhaled nitric oxide Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Follow up at School-Age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study |
Resource links provided by NLM:
MedlinePlus related topics:
Premature Babies
Drug Information available for:
Nitric oxide
U.S. FDA Resources
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Examine health status at early school-age [ Time Frame: 4-7 years of age (between 2005-2006) ] [ Designated as safety issue: No ]
| Enrollment: | 160 |
| Study Start Date: | May 2005 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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).
Eligibility| Ages Eligible for Study: | 4 Years to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152542
Locations
| United States, Illinois | |
| The University of Chicago, Comer Children's Hospital, | |
| Chicago, Illinois, United States, 60637 | |
Sponsors and Collaborators
University of Chicago
INO Therapeutics
Investigators
| Principal Investigator: | Michael D Schreiber, M.D. | University of Chicago |
More Information
Additional Information:
No publications provided by University of Chicago
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael D. Schreiber, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00152542 History of Changes |
| Other Study ID Numbers: | 9549 (temp19), 29078 |
| Study First Received: | September 8, 2005 |
| Last Updated: | March 6, 2009 |
| Health Authority: | United States: Food and Drug Administration |
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 Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Cardiovascular Agents Protective Agents |
ClinicalTrials.gov processed this record on May 22, 2013