Back to resultsNO Need to Ventilate: A Trial of Non-invasive Inhaled Nitric Oxide in Persistent Pulmonary Hypertension of the Newborn
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iNO
Non-invasive nitric oxide
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Persistent pulmonary hypertension, Non-invasive inhaled nitric oxide, iNO
Eligibility Criteria
Inclusion Criteria: Newborn infants >/= 34 weeks with clinical or echocardiographic evidence of PPHN with a PaO2 < 100 of Fio2 0.8 who are not mechanically ventilated Exclusion Criteria: Infants with significant lung disease Inability to sustain spontaneous respirations Lethal congenital anomalies Severe birth asphyxia
Sites / Locations
- Emory University affiliated newborn intensive care units
Outcomes
Primary Outcome Measures
% subjects assigned to non-invasive iNO who do not require intubation and mechanical ventilation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00139217
Brief Title
NO Need to Ventilate: A Trial of Non-invasive Inhaled Nitric Oxide in Persistent Pulmonary Hypertension of the Newborn
Official Title
NO Need to Ventilate: A Trial of Non-invasive iNO in Persistent Pulmonary Hypertension of the Newborn
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of the trial is to determine the feasibility and clinical safety and efficacy of non-invasive inhaled nitric oxide in infants with PPHN without significant pulmonary +-parenchymal disease who would normally receive inhaled nitric oxide only after placement of a tracheal tube and the institution of mechanical ventilation.
Detailed Description
Blending low doses of NO gas with oxygen in the inspiratory limb of mechanical ventilators is an effective method for reducing pulmonary vascular resistance and decreasing extrapulmonary right-to-left shunting at the ductus arteriosus and foramen ovale in many patients with PPHN. However, in some patients with PPHN, sustained elevations of PVR may occur in the absence of or despite improvement in the parenchymal lung disease such that mechanical ventilation is not needed for maintaining adequate gas exchange.
PPN in the absence of pulmonary parenchymal disease or despite improvement in the parenchymal lung disease occurs in a significant subset of newborn infants with hypoxemic respiratory failure. Inhaled NO can be effectively delivered by non-invasive techniques to newborn infants with PPHN, potentially reducing the duration of mechanical ventilation, while safely treating the elevation in pulmonary artery pressure and right-to-left.
A dose of 10-20 ppm measured within the delivery device is sufficient to maintain nasopharyngeal concentrations within a range of 1-10 ppm. My co-authors and I have also reported a series of eleven infants with pulmonary hypertension treated with low dose iNO delivered via nasal cannula after extubation at the 14th Annual CNMC Symposium on ECMO & Advanced Therapies for Respiratory Failure, Keystone, CO, 1998.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Persistent pulmonary hypertension, Non-invasive inhaled nitric oxide, iNO
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
iNO
Intervention Type
Procedure
Intervention Name(s)
Non-invasive nitric oxide
Primary Outcome Measure Information:
Title
% subjects assigned to non-invasive iNO who do not require intubation and mechanical ventilation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newborn infants >/= 34 weeks with clinical or echocardiographic evidence of PPHN with a PaO2 < 100 of Fio2 0.8 who are not mechanically ventilated
Exclusion Criteria:
Infants with significant lung disease
Inability to sustain spontaneous respirations
Lethal congenital anomalies
Severe birth asphyxia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Golde Dudell, M.D.
Organizational Affiliation
Emory University, Department of Pediatrics, Division of Neonatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University affiliated newborn intensive care units
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NO Need to Ventilate: A Trial of Non-invasive Inhaled Nitric Oxide in Persistent Pulmonary Hypertension of the Newborn
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