Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
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.
|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|
- 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 ]
- 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 ]
|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)|
Placebo Comparator: Placebo
Nitrogen at 20 ppm
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.
Nitric Oxide 20 ppm
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220687
|Contact: Kris Sekar, M.D.||email@example.com|
|Contact: Michael McCoy, MSfirstname.lastname@example.org|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Kris Sekar, M.D. 405-271-5215 email@example.com|
|Contact: Michael McCoy, M.S. 405-271-5215 firstname.lastname@example.org|
|Principal Investigator: Kris Sekar, M.D.|
|Principal Investigator:||Kris Sekar, M.D.||University of Oklahoma|