Expired Study
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Salt Lake City, Utah 84132


Purpose:

This is a chart review study of neonates admitted to Primary Children's Medical Center or University of Utah NICU who had or developed a diagnosis of bronchopulmonary dysplasia (BPD) and were treated for this condition with inhaled nitric oxide (iNO) beginning after the 4th week of life. For this study BPD will be defined as need for supplemental oxygen on day 28 of life. The data collection from the medical record will gather demographics on admission (birth weight, gestational age, etc); past medical history from transferring hospitals; admission diagnoses; hospital respiratory care treatment course and laboratory/xray findings; nutrition and growth; and discharge diagnoses including all major neonatal morbidities such as absence or severity of intraventricular hemorrhage, retinopathy of prematurity, or hearing deficits. The data will be compiled and compared to data previously published on similar infants with BPD but not treated with iNO.


Study summary:

Recent studies (e.g. Schreiber 2003)1 have prompted several large current clinical trials on the use of inhaled nitric oxide (iNO) for the prevention of bronchopulmonary dysplasia (BPD) in preterm infants. Results of these studies are not yet published and will be forthcoming Spring 2006. However, there is evidence to suggest that for patients with BPD, treatment with iNO may improve oxygenation2 and improve pulmonary blood flow by relaxing pulmonary vascular tone. 3 Also, there is a recent primate study that suggests in the face of existing BPD, treatment with iNO may decrease oxygen and ventilation requirements through a mechanism that helps preserve surfactant protein.4 Taken together, this preliminary work suggests there may be clinical benefit in treating established BPD with iNO. However, as few data exist on the clinical course of BPD patients treated with iNO, further description is necessary to evaluate iNO as a potential treatment modality for BPD. Since iNO has been used as adjunctive therapy for neonates at PCMC with serious respiratory disease, useful information on the relationship between BPD and iNO treatment may exist within our own patient population


Criteria:

Inclusion Criteria: - Any patient who at 28 days of life was requiring oxygen therapy in the Neonatal Intensive Care Unit and who was then treated with iNO would be eligible for chart review. Since iNO therapy has only been available for a few years, this study will attempt to capture all patients who qualify. Exclusion Criteria: - Any patient who received iNO treatment under an IRB study protocol after 28d of life would not be eligible for chart review.


Study is Available At:


Original ID:

17091


NCT ID:

NCT00757146


Secondary ID:


Study Acronym:


Brief Title:

Neonatal Intensive Care (NICU) Course and Hospital Outcome of Infants With BPD Treated Using Inhaled Nitric Oxide


Official Title:

NICU Course and Hospital Outcome of Infants With Bronchopulmonary Dysplasia Treated Using Inhaled Nitric Oxide


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

28 Days


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Utah


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Retrospective


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Donald .Null, MD
Principal Investigator
University of Utah / Primary Childrens Hospital

Study Dates

Start Date:March 2006
Completion Date:February 2010
Completion Type:Actual
Primary Completion Date:February 2010
Primary Completion Type:Actual
Verification Date:June 2010
Last Changed Date:June 22, 2010
First Received Date:September 19, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Gather descriptive information on the hospital course and outcome of infants treated with iNO who had a diagnosis of BPD.
Time Frame:2 years
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Utah

Samples and Retentions

Study Population: Any patient who at 28 days of life was requiring oxygen therapy in the Neonatal Intensive Care Unit and who was then treated with iNO would be eligible for chart review. Since iNO therapy has only been available for a few years, this study will attempt to capture all patients who qualify. Any patient who received iNO treatment under an IRB study protocol after 28d of life would not be eligible for chart review.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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