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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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