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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo 20ppm | Placebo Comparator | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNO | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Factional Inspired Oxygen Percent (FiO2) | 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. | 20 minutes |
| Rate of Hyperoxia | FiO2 >60% at any 5 second increment during the study period of 20 minutes for each infant in each arm. | 20 minutes |
| Pre and Postductal Saturation Levels | 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. | at 20 minutes (end of study) |
| Heart Rate During Resuscitation | Measured and recorded heart rates every 5 seconds on study as described as beats per minute (BPM) | 5, 10 and 20 minutes on study |
| Need for Intubation | Infants requiring placement of endotracheal tube as part of the Neonatal Resuscitation Program algorithm for airway management. | by end of study, 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Intraventricular Hemorrhage > Grade 2 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kris Sekar, M.D. | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States | ||
| University of Oklahoma, Childrens Hospital |
Abstract presented to The Pediatric Academic Society Meeting, May 9, 2017
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64 consented mothers or infants met subsequent exclusion criteria. Of those, only 33 were enrolled at time of delivery. Most common exclusion was aging out of gestational age limit, precipitous delivery, or no team available.
Women admitted in preterm labor with gestational ages of 25 0/7 to 31 6/7 weeks gestation were approached for prenatal consent. 171 mothers were identified, 95 mothers consented
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| FG001 | iNO 20 Ppm | 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Gestational Age at birth in Weeks |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Factional Inspired Oxygen Percent (FiO2) | 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. | Posted | Mean | Inter-Quartile Range | percentage of Inspired Oxygen | 20 minutes |
|
Adverse Events were recorded until discharge from the hospital, average age at discharge for all infants who completed study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
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Small sample size. Recruitment was terminated before reaching our initial target sample size due to precipitous and emergent deliveries, unavailability of the team or baby ineligible due to gestational age at birth.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krishnamurhty Sekar, MD, Professor of Pediatrics | OUHSC College of Medicine, Pediatrics, Neonatal-Perinatal Medicine | 405-271-5215 | kris-sekar@ouhsc.edu |
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| ID | Term |
|---|---|
| C566881 | Respiratory Distress Syndrome In Premature Infants |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D009584 | Nitrogen |
| ID | Term |
|---|---|
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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|
|
| Nitrogen | Other | 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. |
|
| Hospital Discharge |
| Infants With Patent Ductus Arteriosus (PDA) Requiring Treatment | Count of patients requiring either pharmacologic or surgical treatment for persistent PDA | Prior to infant discharge from the hospital |
| Retinopathy of Prematurity (ROP)> Stage 2 | 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) | Prior to infant discharge from the hospital |
| Mechanical Ventilation, Non-invasive Ventilation (NIV), and Length of Stay in Days (LOS) | 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. | Prior to infant discharge from the hospital |
| Bronchopulmonary Dysplasia | 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. | at 36 weeks adjusted gestational age of participant |
| Late Onset Sepsis | Late Onset Sepsis as described as infection after day 5 of life. This would include all patients who survived to day of life 5. | at any time during study period |
| Oklahoma City |
| Oklahoma |
| 73104 |
| United States |
| BG001 | iNO 20 Ppm | 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 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. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Birthweight | Median | Inter-Quartile Range | Grams |
|
| Apgar Score at one minute | Scale of 0-10 with 0 indicating no heart rate, no respirations, unresponsive to 10 vigorous, pink, active, good heart rate and respirations. | Median | Inter-Quartile Range | units on a scale |
|
| Apgar Score at 5 minutes | Scale of 0-10 with 0 indicating no heart rate, no respirations, unresponsive to 10 vigorous, pink, active, good heart rate and respirations. | Median | Inter-Quartile Range | units on a scale |
|
| Any Antenatal Steroid | Count of Participants | Participants |
|
| Chorioamnionitis | Count of Participants | Participants |
|
| Rupture of Membranes (ROM) greater than 18 hours | Count of Participants | Participants |
|
| Maternal Preeclampsia | Count of Participants | Participants |
|
| OG001 | iNO 20 Ppm | 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 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. |
|
|
|
| Primary | Rate of Hyperoxia | FiO2 >60% at any 5 second increment during the study period of 20 minutes for each infant in each arm. | Posted | Number | Observations on >60% FiO2 | 20 minutes |
|
|
|
|
| Primary | Pre and Postductal Saturation Levels | 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. | Posted | Mean | Standard Deviation | Percent Saturation | at 20 minutes (end of study) |
|
|
|
| Primary | Heart Rate During Resuscitation | Measured and recorded heart rates every 5 seconds on study as described as beats per minute (BPM) | Posted | Mean | Standard Deviation | BPM | 5, 10 and 20 minutes on study |
|
|
|
| Primary | Need for Intubation | Infants requiring placement of endotracheal tube as part of the Neonatal Resuscitation Program algorithm for airway management. | Posted | Count of Participants | Participants | by end of study, 20 minutes |
|
|
|
| Secondary | Intraventricular Hemorrhage > Grade 2 | 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 | Posted | Count of Participants | Participants | Hospital Discharge |
|
|
|
| Secondary | Infants With Patent Ductus Arteriosus (PDA) Requiring Treatment | Count of patients requiring either pharmacologic or surgical treatment for persistent PDA | Posted | Count of Participants | Participants | Prior to infant discharge from the hospital |
|
|
|
| Secondary | Retinopathy of Prematurity (ROP)> Stage 2 | 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) | 2 of the 14 patients in the placebo arm died and had no ROP exam, 3 of the 14 patients in the INO Group died and had no ROP exam. | Posted | Count of Participants | Participants | Prior to infant discharge from the hospital |
|
|
|
| Secondary | Mechanical Ventilation, Non-invasive Ventilation (NIV), and Length of Stay in Days (LOS) | 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. | 2 of the 14 patients in the placebo arm died were not included in the analysis, 1 of the 14 patients in the INO Group was excluded for pulmonary hypoplasia.. | Posted | Median | Inter-Quartile Range | Days | Prior to infant discharge from the hospital |
|
|
|
| Secondary | Bronchopulmonary Dysplasia | 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. | Posted | Count of Participants | Participants | at 36 weeks adjusted gestational age of participant |
|
|
|
| Secondary | Late Onset Sepsis | Late Onset Sepsis as described as infection after day 5 of life. This would include all patients who survived to day of life 5. | Posted | Count of Participants | Participants | at any time during study period |
|
|
|
| 1 |
| 14 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | iNO 20 Ppm | 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 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. | 2 | 14 | 0 | 12 | 0 | 12 |
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| D000091642 | Urogenital Diseases |
| BPM at 20 minutes |
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| LOS |
|