Administration of Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation Protocol: A Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oklahoma
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Maximum Factional Inspired Oxygen Percent (FiO2)
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Minute to 2 Minutes (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infants that are 25 0/7 - 31 6/7 weeks gestation
- •Infants who require Continuous Positive Airway Pressure (CPAP) or Positive Pressure Ventilation ( 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
Arms & Interventions
Placebo 20ppm
Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Intervention: Nitrogen (Other)
Inhaled Nitric Oxide (iNO) 20 ppm
Inhaled Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study
Intervention: iNO (Drug)
Outcomes
Primary Outcomes
Maximum Factional Inspired Oxygen Percent (FiO2)
Time Frame: 20 minutes
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 Neonatal Resuscitation Program (NRP) protocol.
Rate of Hyperoxia
Time Frame: 20 minutes
FiO2 \>60% at any 5 second increment during the study period of 20 minutes for each infant in each arm.
Pre and Postductal Saturation Levels
Time Frame: at 20 minutes (end of study)
Oxygen saturations as described as preductal (right hand) as well as post ductal (either foot) and measured as percent of saturated hemoglobin by pulse oximetry.
Heart Rate During Resuscitation
Time Frame: 5, 10 and 20 minutes on study
Measured and recorded heart rates every 5 seconds on study as described as beats per minute (BPM)
Need for Intubation
Time Frame: by end of study, 20 minutes
Infants requiring placement of endotracheal tube as part of the Neonatal Resuscitation Program algorithm for airway management.
Secondary Outcomes
- Infants With Patent Ductus Arteriosus (PDA) Requiring Treatment(Prior to infant discharge from the hospital)
- Mechanical Ventilation, Non-invasive Ventilation (NIV), and Length of Stay in Days (LOS)(Prior to infant discharge from the hospital)
- Bronchopulmonary Dysplasia(at 36 weeks adjusted gestational age of participant)
- Intraventricular Hemorrhage > Grade 2(Hospital Discharge)
- Late Onset Sepsis(at any time during study period)
- Retinopathy of Prematurity (ROP)> Stage 2(Prior to infant discharge from the hospital)