NO Need to Ventilate: A Trial of Non-invasive Inhaled Nitric Oxide in Persistent Pulmonary Hypertension of the Newborn

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00139217
First received: August 29, 2005
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Pulmonary Hypertension
Drug: iNO
Procedure: Non-invasive nitric oxide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NO Need to Ventilate: A Trial of Non-invasive iNO in Persistent Pulmonary Hypertension of the Newborn

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • % subjects assigned to non-invasive iNO who do not require intubation and mechanical ventilation

Estimated Enrollment: 400
Study Start Date: August 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00139217

Locations
United States, Georgia
Emory University affiliated newborn intensive care units
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Golde Dudell, M.D. Emory University, Department of Pediatrics, Division of Neonatology
  More Information

No publications provided

Responsible Party: William T. Mahle, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00139217     History of Changes
Other Study ID Numbers: 1386-2004
Study First Received: August 29, 2005
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Persistent pulmonary hypertension
Non-invasive inhaled nitric oxide
iNO

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract 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
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on August 01, 2014