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

Primary Purpose

Prematurity, Respiratory Distress Syndrome,Hypoxemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Inhaled nitric oxide
Placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prematurity, Respiratory Distress Syndrome,Hypoxemia focused on measuring Inhaled nitric oxide,, Lung recruitment,, Ventilatory approach,, Neurodevelopmental outcomes,, School age children

Eligibility Criteria

4 Years - 6 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • The University of Chicago, Comer Children's Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inhaled nitric oxide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Examine school-readiness at school-age in premature infants treated with iNO or placebo in the first week of life

Secondary Outcome Measures

Examine health status at early school-age

Full Information

First Posted
September 8, 2005
Last Updated
June 11, 2013
Sponsor
University of Chicago
Collaborators
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT00152542
Brief Title
Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants
Official Title
Follow up at School-age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Mallinckrodt

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Respiratory Distress Syndrome,Hypoxemia
Keywords
Inhaled nitric oxide,, Lung recruitment,, Ventilatory approach,, Neurodevelopmental outcomes,, School age children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled nitric oxide
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Inhaled nitric oxide
Intervention Description
1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
No iNO given for days 1-7
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Examine health status at early school-age
Time Frame
4-7 years of age (between 2005-2006)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Schreiber, M.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago, Comer Children's Hospital,
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21054515
Citation
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.
Results Reference
derived

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

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