Skip to main content
OpenTrials
Completed

NCT Number: NCT00139217

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University affiliated newborn intensive care units

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iNO

Drug

Non-invasive nitric oxide

Procedure

Primary outcomes

  1. % subjects assigned to non-invasive iNO who do not require intubation and mechanical ventilation

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 31, 2005
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.