Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants

The University of Chicago

Status and phase: Completed; Phase 3

Conditions: Prematurity, Respiratory Distress Syndrome,Hypoxemia

Treatments: Drug: Placebo; Drug: Inhaled nitric oxide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00152542

9549 (temp19)

29078

Details and patient eligibility

About

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.

Full 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).

Enrollment: 160 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Inhaled nitric oxide

Experimental group

Treatment:

Drug: Inhaled nitric oxide

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo