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

This study has been completed.
Sponsor:
Collaborator:
INO Therapeutics
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00152542
First received: September 8, 2005
Last updated: June 11, 2013
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Prematurity, Respiratory Distress Syndrome,Hypoxemia
Drug: Inhaled nitric oxide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Follow up at School-age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Examine health status at early school-age [ Time Frame: 4-7 years of age (between 2005-2006) ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: May 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled nitric oxide Drug: Inhaled nitric oxide
1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7
Placebo Comparator: Placebo Drug: Placebo
No iNO given for days 1-7

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).

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152542

Locations
United States, Illinois
The University of Chicago, Comer Children's Hospital,
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
INO Therapeutics
Investigators
Principal Investigator: Michael D Schreiber, M.D. University of Chicago
  More Information

Additional Information:
No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00152542     History of Changes
Other Study ID Numbers: 9549 (temp19), 29078
Study First Received: September 8, 2005
Last Updated: June 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
Inhaled nitric oxide,
Lung recruitment,
Ventilatory approach,
Neurodevelopmental outcomes,
School age children

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Nitric Oxide
Anti-Asthmatic Agents
Antioxidants
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Gasotransmitters
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014