Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139217
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2005-08-29
Brief Title:
NO Need to Ventilate A Trial of Non-invasive Inhaled Nitric Oxide in Persistent Pulmonary Hypertension of the Newborn
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
NO Need to Ventilate A Trial of Non-invasive iNO in Persistent Pulmonary Hypertension of the Newborn
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None