Not Signed In -
Respiratory Infection |
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Clinical Trial: Follow Up at School-Age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants
This study is no longer recruiting patients.
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Purpose
Our previous data demonstrated that premature infants treated with inhaled nitric oxide at birth had improved neurodevelopmental ourcomes 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: nitric oxide | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Follow Up at School-Ag of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study
Further Study Details:
Primary Outcomes: To demonstrate the effect on oxygenation
Secondary Outcomes: To demonstrate the effect on pulmonary,and clinical outcomes
Expected Total Enrollment: 160
Secondary Outcomes: To demonstrate the effect on pulmonary,and clinical outcomes
Expected Total Enrollment: 160
Study start: May 2005; Study completion: May 2006
Last follow-up: April 2006; Data entry closure: May 2006
Two questionaires(truncated versions of previously validated surverys),one for parent and another for teacher,for which written consent was previously obtained are being sent to parents. The teacher questionaires will be delivered via parents. A clinic visit will accompany age appropriate neurodevelopmental examination, adminstration of the Functional Independence Measure for Children(WeeFIM) survey, and hearing and visual screening exams(if appropriate).
Eligibility
Ages Eligible for Study: 4 Years - 6 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
childeren who participated in NOVA study and becoming school aged -
Exclusion Criteria:
children who participated in NOVA study but deceased post after discharge-
Location Information
Illinois
The University of Chicago, Comer Children''''s Hospital,, Chicago, Illinois, 60637, United States
Study chairs or principal investigators
Michael D Schreiber, M.D., Principal Investigator, University of Chicago
More Information
Study ID Numbers: 9549 (temp19); 29078
Last Updated: September 8, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00152542
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 8, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00152542
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Bacterial vs Viral/Respiratory Tract Infections: When Should Antibiotics be Taken? (Cleveland Clinic)
- Respiratory Infection (Cleveland Clinic)
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