Follow up at School-age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study
Overview
- Phase
- Phase 3
- Intervention
- Inhaled nitric oxide
- Conditions
- Prematurity, Respiratory Distress Syndrome,Hypoxemia
- Sponsor
- University of Chicago
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Examine school-readiness at school-age in premature infants treated with iNO or placebo in the first week of life
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
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).
Investigators
Eligibility 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
Arms & Interventions
Inhaled nitric oxide
Intervention: Inhaled nitric oxide
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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 Outcomes
- Examine health status at early school-age(4-7 years of age (between 2005-2006))