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OpenTrials
Completed

NCT Number: NCT00152542

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

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.

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Key information

Conditions

Prematurity, Respiratory Distress Syndrome,Hypoxemia Female Urogenital Diseases and Pregnancy Complications Hypoxia Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of Chicago, Comer Children's Hospital,

Chicago, Illinois, 60637, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled Nitric Oxide

Drug

1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7

Placebo

Drug

No iNO given for days 1-7

Primary outcomes

  1. 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

  1. Examine health status at early school-age

    Time frame: 4-7 years of age (between 2005-2006)

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Mallinckrodt

Registry information

Official study title

Follow up at School-age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
Jun 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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