Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants
- Conditions
- Prematurity, Respiratory Distress Syndrome,Hypoxemia
- Interventions
- Drug: Inhaled nitric oxideDrug: Placebo
- Registration Number
- NCT00152542
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- Children who participated in NOVA study and are of school age
- Children who participated in NOVA study but deceased post discharge
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaled nitric oxide Inhaled nitric oxide - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Examine health status at early school-age 4-7 years of age (between 2005-2006)
Trial Locations
- Locations (1)
The University of Chicago, Comer Children's Hospital,
🇺🇸Chicago, Illinois, United States