Prematurity, Respiratory Distress Syndrome,Hypoxemia
Conditions
Keywords
Inhaled nitric oxide,, Lung recruitment,, Ventilatory approach,, Neurodevelopmental outcomes,, School age children
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).
Interventions
DRUGInhaled nitric oxide
1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7
DRUGPlacebo
No iNO given for days 1-7
Sponsors
Mallinckrodt
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Examine health status at early school-age | 4-7 years of age (between 2005-2006) |
Countries
United States
Outcome results
None listed