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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50HL084923 | U.S. NIH Grant/Contract | View source | |
| 5 P50 HL084923-030001 |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns. The condition involves abnormal development of lung tissue and is characterized by inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce the incidence of BPD and another commonly associated condition called pulmonary hypertension, which is high blood pressure in the vessels carrying blood to the lungs.. This study will determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary hypertension, and death in premature newborns.
BPD is a serious lung condition that primarily affects premature newborns and newborns with low birth weights. iNO has been proven to be a safe and effective treatment for pulmonary hypertension and hypoxemic respiratory failure-both of which are abnormal lung conditions-in full-term newborns. However, in babies born prematurely, the effects of iNO on lung function are not well defined. Also, previous studies have mainly examined whether iNO reduces the incidence of BPD in newborns who are on mechanical ventilation. However, intubation and mechanical ventilation of premature newborns is now increasingly being avoided, and non-invasive support, including the use of nasal continuous positive airway pressure (NCPAP), is being used. Early treatment with low-dose iNO may reduce the incidence of BPD in premature newborns who do not require mechanical ventilation and intubation after delivery. The purpose of this study is to determine if low-dose, non-invasive iNO reduces the risk of BPD, pulmonary hypertension, and death in premature newborns who do not require mechanical ventilation.
This study will enroll premature newborns who require extra oxygen but do not require intubation or mechanical ventilation for respiratory failure in the first 72 hours of life. Participants will be randomly assigned to receive low-dose, non-invasive iNO or nitrogen (placebo) during their hospital stay. While hospitalized, participants' heart rate, blood oxygen level breathing rate, blood pressure, and medications will be monitored, and blood collection will occur at various times. Monitoring will continue until participants are 30 weeks corrected gestational age or for at least 14 days if participants are born at 29 weeks or more. All participants will undergo an ultrasound of the head when they are 7 days, 28 days, and 36 weeks of age. They will undergo an echocardiogram, which is an ultrasound of the heart, at 7 and 21 days of age and 4 weeks before the original expected due date. A chest x-ray will be performed before hospital discharge, and a breathing status test will be performed either 4 weeks before participants' original expected due date or before hospital discharge. Follow-up study visits will occur at Years 1 and 2, and will include a physical examination and developmental and behavioral testing. Another echocardiogram will also be performed at the Year 1 visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Nitric Oxide (iNO) | Experimental | Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. |
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| Nitrogen (placebo) | Placebo Comparator | Participants will receive nitrogen (placebo) while in the hospital. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Nitric Oxide (iNO) | Drug | iNO will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Number of participants that developed bronchopulmonary dysplasia and/or that died | Week 36 or earlier, if participants are discharged from the hospital |
| Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight | Number of participants that developed bronchopulmonary dysplasia and/or that died, stratified by birth weight (grams) | Randomization to discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Bronchopulmonary Dysplasia (BPD) | Assessment of the severity of BPD as defined by the oxygen reduction test | 36 weeks corrected gestational age |
| Need for Mechanical Ventilation | Number of participants who required endotracheal intubation and mechanical ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| Days in Hospital | Length of stay of participants | From birth to hospital discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Kinsella, MD | Chidlren's Hospital and University of Colorado Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35242 | United States | ||
| University of California San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25063725 | Derived | Kinsella JP, Cutter GR, Steinhorn RH, Nelin LD, Walsh WF, Finer NN, Abman SH. Noninvasive inhaled nitric oxide does not prevent bronchopulmonary dysplasia in premature newborns. J Pediatr. 2014 Dec;165(6):1104-1108.e1. doi: 10.1016/j.jpeds.2014.06.018. Epub 2014 Jul 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 500-749g Inhaled Nitric Oxide (iNO) | Participants weighing between 500 and 749 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Nitrogen (placebo) | Drug | Nitrogen will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx). |
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| Anytime after randomization up to 36 weeks corrected gestational age |
| Total Ventilation Days | Of those participants who required mechanical ventilation, the total number of days receiving ventilation | After randomization up until hospital discharge |
| Necrotizing Enterocolitis (NEC) | Number of participants diagnosed with necrotizing enterocolitis | After randomization through hospital discharge |
| Symptomatic PDA Requiring Medical Treatment | Number of participants with a symptomatic PDA that required medical treatment | From randomization until discharge |
| Symptomatic PDA Requiring Surgical Ligation | Number of participants with symptomatic PDA that required surgical ligation | Randomization through discharge |
| Threshold Retinopathy of Prematurity (ROP) | Threshold ROP defined as requiring interventional therapy | Randomization to discharge |
| Severe Intracranial Hemorrhage | Number of participants that developed severe intracranial hemorrhage (grade 3-4) | Randomization to discharge |
| Sepsis | Number of participants that developed sepsis | Randomization to discharge |
| San Diego |
| California |
| 92123 |
| United States |
| Children's Hospital and University Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Anne and Robert H. Lurie Children's Hospital of Chicago and Northwestern Memorial Hospital | Chicago | Illinois | 60614 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37232 | United States |
| 500-749g Placebo (Nitrogen) |
Participants weighing between 500 and 749 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx. |
| FG002 | 750-999g Inhaled Nitric Oxide (iNO) | Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx. |
| FG003 | 750-999g Placebo (Nitrogen) | Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx. |
| FG004 | 1000-1250g Inhaled Nitric Oxide (iNO) | Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx. |
| FG005 | 1000-1250g Placebo (Nitrogen) | Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Nitric Oxide (iNO) | Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx). |
| BG001 | Placebo (Nitrogen) | Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | Weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Mother's race/ethnic group | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality | Number of participants that developed bronchopulmonary dysplasia and/or that died | Posted | Count of Participants | Participants | Week 36 or earlier, if participants are discharged from the hospital |
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| Primary | Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight | Number of participants that developed bronchopulmonary dysplasia and/or that died, stratified by birth weight (grams) | Posted | Count of Participants | Participants | Randomization to discharge |
| ||||||||||||||||||||||||||||||||||
| Secondary | Severity of Bronchopulmonary Dysplasia (BPD) | Assessment of the severity of BPD as defined by the oxygen reduction test | Posted | Count of Participants | Participants | 36 weeks corrected gestational age |
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| Secondary | Need for Mechanical Ventilation | Number of participants who required endotracheal intubation and mechanical ventilation | Posted | Count of Participants | Participants | Anytime after randomization up to 36 weeks corrected gestational age |
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| Secondary | Total Ventilation Days | Of those participants who required mechanical ventilation, the total number of days receiving ventilation | Posted | Mean | Standard Deviation | Days | After randomization up until hospital discharge |
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| Secondary | Necrotizing Enterocolitis (NEC) | Number of participants diagnosed with necrotizing enterocolitis | Posted | Count of Participants | Participants | After randomization through hospital discharge |
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| Secondary | Symptomatic PDA Requiring Medical Treatment | Number of participants with a symptomatic PDA that required medical treatment | Posted | Count of Participants | Participants | From randomization until discharge |
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| Secondary | Symptomatic PDA Requiring Surgical Ligation | Number of participants with symptomatic PDA that required surgical ligation | Posted | Count of Participants | Participants | Randomization through discharge |
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| Secondary | Threshold Retinopathy of Prematurity (ROP) | Threshold ROP defined as requiring interventional therapy | Posted | Count of Participants | Participants | Randomization to discharge |
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| Secondary | Severe Intracranial Hemorrhage | Number of participants that developed severe intracranial hemorrhage (grade 3-4) | Posted | Count of Participants | Participants | Randomization to discharge |
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| Secondary | Sepsis | Number of participants that developed sepsis | Posted | Count of Participants | Participants | Randomization to discharge |
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| Other Pre-specified | Days in Hospital | Length of stay of participants | Posted | Mean | Standard Deviation | Days | From birth to hospital discharge |
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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 | Inhaled Nitric Oxide (iNO) | Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx). | 2 | 59 | 27 | 59 | 0 | 59 |
| EG001 | Placebo (Nitrogen) | Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx). | 4 | 65 | 42 | 65 | 0 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Necrotizing enterocolitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Symptomatic PDA | Cardiac disorders | Systematic Assessment | Medical treatment |
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| Symptomatic PDA | Cardiac disorders | Systematic Assessment | surgical treatment |
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| Threshold ROP | Eye disorders | Systematic Assessment |
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| Severe ICH | Nervous system disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Kinsella | University of Colorado School of Medicine/Children's Hospital Colorado | (303) 724-2853 | john.kinsella@ucdenver.edu |
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D009584 | Nitrogen |
| ID | Term |
|---|---|
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Male |
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| Black |
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| Other |
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| Death/BPD |
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| No Death or BPD |
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| OG003 | 750-999g Placebo (Nitrogen) | Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx. |
| OG004 | 1000-1250g Inhaled Nitric Oxide (iNO) | Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx. |
| OG005 | 1000-1250g Placebo (Nitrogen) | Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more. Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx. |
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