Neonatal Intensive Care (NICU) Course and Hospital Outcome of Infants With BPD Treated Using Inhaled Nitric Oxide
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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.
| Condition |
|---|
|
Bronchopulmonary Dysplasia |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | NICU Course and Hospital Outcome of Infants With Bronchopulmonary Dysplasia Treated Using Inhaled Nitric Oxide |
- Gather descriptive information on the hospital course and outcome of infants treated with iNO who had a diagnosis of BPD. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | March 2006 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations| United States, Utah | |
| Univesity of Utah / Primary Childrens Medical Center | |
| Salt Lake City, Utah, United States, 84132 | |
| Principal Investigator: | Donald .Null, MD | University of Utah / Primary Childrens Hospital |
More Information
No publications provided
| Responsible Party: | Donald Null, University of Utah / Primary Childrens Hospital |
| ClinicalTrials.gov Identifier: | NCT00757146 History of Changes |
| Other Study ID Numbers: | 17091 |
| Study First Received: | September 19, 2008 |
| Last Updated: | June 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
chronic lung disease bronchopulmonary dysplasia inhaled nitric oxide premature infants |
Additional relevant MeSH terms:
|
Bronchopulmonary Dysplasia Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Cardiovascular Agents Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013