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

Not Applicable

Completed

Conditions: Respiratory Distress Syndrome in Premature Infants
Very Low Birth Weight Baby

Interventions: Other: Nitrogen
Drug: iNO

Registration Number: NCT01220687

Lead Sponsor: University of Oklahoma

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo 20ppm	Nitrogen	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
Inhaled Nitric Oxide (iNO) 20 ppm	iNO	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

Primary Outcome Measures

Name	Time	Method
Maximum Factional Inspired Oxygen Percent (FiO2)	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	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	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	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	by end of study, 20 minutes	Infants requiring placement of endotracheal tube as part of the Neonatal Resuscitation Program algorithm for airway management.

Secondary Outcome Measures

Name	Time	Method
Infants With Patent Ductus Arteriosus (PDA) Requiring Treatment	Prior to infant discharge from the hospital	Count of patients requiring either pharmacologic or surgical treatment for persistent PDA
Mechanical Ventilation, Non-invasive Ventilation (NIV), and Length of Stay in Days (LOS)	Prior to infant discharge from the hospital	endotracheal or other airway placement and mechanical ventilation in days, days of non-invasive ventilation as described as nasal ventilation, CPAP, high flow and low flow oxygen as counted in days. Only infants who survived to discharge were included in this analysis.
Bronchopulmonary Dysplasia	at 36 weeks adjusted gestational age of participant	Bronchopulmonary Dysplasia as described as oxygen need at 36 weeks adjusted gestational age. Only infants who survived to 36 weeks gestation were included in this analysis.
Intraventricular Hemorrhage > Grade 2	Hospital Discharge	Intraventricular Hemorrhage (IVH) \> Gr 2 as described by radiographic scale as described in "Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm.", Papile L A; Burstein J; Burstein R; Koffler H, The Journal of pediatrics, (1978 Apr) Vol. 92, No. 4, pp. 529-34. Journal code: 0375410. ISSN: 0022-3476. L-ISSN: 0022-3476. IVH classification systems Papile system Grade I Subependymal hemorrhage Grade II IVH without ventricular dilation Grade III IVH with ventricular dilation Grade IV Extensive IVH with parenchymal involvement
Late Onset Sepsis	at any time during study period	Late Onset Sepsis as described as infection after day 5 of life. This would include all patients who survived to day of life 5.
Retinopathy of Prematurity (ROP)> Stage 2	Prior to infant discharge from the hospital	Staging of any retinal disease as described by the standard screening by the American Association for Pediatric Ophthalmology and Strabismus. Only infants who survived to obtain retinal imaging are included (12 in Placebo arm and 11 in INO arm)

Trial Locations

Locations (2): University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, United States
University of Oklahoma, Childrens Hospital
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Oklahoma City, Oklahoma, United States