Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Oklahoma
Sponsor:
Collaborator:
Ikaria
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01220687
First received: October 7, 2010
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame. Although the use of oxygen in management of breathing is an important part of supporting baby immediately after delivery, there is more evidence that too much exposure to oxygen may lead to potential problems for your baby later. Oxygen exposure can be harmful to premature babies developing lungs.


Condition Intervention Phase
Prematurity
Low Birth Weight
Drug: iNO
Other: Nitrogen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Administration of Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation Protocol: A Pilot Trial

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • To investigate whether iNO decreases the supplemental oxygen exposure in the preterm infants who require continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) during resuscitation as per NRP protocol. [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine heart rate, respiratory rate, O2 saturation, cerebral O2 extraction, need for intubation and PPV in the first 20 min of life; to investigate potential impact of resuscitation with iNO on hemodynamics within the first 72 hours of life. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Nitrogen at 20 ppm
Other: Nitrogen
Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
Experimental: iNO
Nitric Oxide 20 ppm
Drug: iNO
Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.

Detailed Description:

Current Neonatal Resuscitation Program (NRP) guidelines suggest the use of supplemental oxygen up to fraction of inspired oxygen of 1.0 during neonatal resuscitation for both term and preterm newborns. Exposure to supplemental oxygen in preterm babies has been shown to have significant toxicity. Even minimal exposure in the first hours of life has been shown to be associated with morbidity including later onset of cancer. The transition from fetal circulation to neonatal circulation is a complex process requiring lung inflation and decrease in pulmonary vascular resistance. Endogenous nitric oxide, along with oxygen, plays a major role in facilitating this transition by decreasing pulmonary vascular resistance. It is not known whether exogenous nitric oxide would facilitate this transition. In this study, we propose a novel approach to resuscitation of preterm infants where inhaled nitric oxide (iNO) will be used as an adjunct to oxygen with the primary goal of reducing supplemental oxygen exposure. This study is designed to be a double-blind, randomized, -placebo- controlled pilot trial with strict monitoring of parameters during transition in the delivery room.

  Eligibility

Ages Eligible for Study:   up to 2 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants that are 25 0/7 - 31 6/7 weeks gestation
  • Infants who require CPAP or PPV during delivery room resuscitation.

Exclusion Criteria:

  • Refusal of consent
  • Known complex congenital anomalies of the heart or lungs
  • Known major genetic defects
  • Hydrops fetalis
  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: NCT01220687

Contacts
Contact: Kris Sekar, M.D. 405-271-5215 kris-sekar@ouhsc.edu
Contact: Michael McCoy, MS 405-271-5215 michael-mccoy@ouhsc.edu

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kris Sekar, M.D.    405-271-5215    kris-sekar@ouhsc.edu   
Contact: Michael McCoy, M.S.    405-271-5215    mike-mccoy@ouhsc.edu   
Principal Investigator: Kris Sekar, M.D.         
Sponsors and Collaborators
University of Oklahoma
Ikaria
Investigators
Principal Investigator: Kris Sekar, M.D. University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01220687     History of Changes
Other Study ID Numbers: 1976
Study First Received: October 7, 2010
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
Prematurity
Oxygen exposure
Nitric Oxide

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
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 September 18, 2014