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

NCT ID: NCT00152542

Last Updated: 2013-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-09-30

Brief Summary

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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

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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).

Conditions

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Prematurity, Respiratory Distress Syndrome,Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inhaled nitric oxide

Group Type EXPERIMENTAL

Inhaled nitric oxide

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

No iNO given for days 1-7

Interventions

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Inhaled nitric oxide

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

Intervention Type DRUG

Placebo

No iNO given for days 1-7

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mallinckrodt

INDUSTRY

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael D Schreiber, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago, Comer Children's Hospital,

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Patrianakos-Hoobler AI, Marks JD, Msall ME, Huo D, Schreiber MD. Safety and efficacy of inhaled nitric oxide treatment for premature infants with respiratory distress syndrome: follow-up evaluation at early school age. Acta Paediatr. 2011 Apr;100(4):524-8. doi: 10.1111/j.1651-2227.2010.02077.x. Epub 2010 Dec 1.

Reference Type DERIVED
PMID: 21054515 (View on PubMed)

Other Identifiers

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29078

Identifier Type: -

Identifier Source: secondary_id

9549 (temp19)

Identifier Type: -

Identifier Source: org_study_id

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