Not provided
Not provided
Not provided
Not provided
The pace of patient enrolledment forced recruitment to stop after 273 patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.
With the advances in modern neonatal intensive care medicine in the last 20 years, survival of extremely preterm infants weighing less than 1500g (< 3 lbs, 5 oz) has risen markedly. However, with this increased survival has come a marked increase in the number of infants with serious neurodevelopmental disabilities: Premature infants with birth weights less than 1500g who survive to go home are at significant risk for serious neurodevelopmental problems: cognitive and motor delays, blindness, deafness, and cerebral palsy. In a recent randomized, placebo-controlled clinical trial, we assessed whether giving mechanically ventilated preterm infants inhaled nitric oxide gas (iNO) for 1 week after birth decreased the incidence of death and chronic lung disease. An unanticipated outcome of that study (Schreiber et. al. 2003) and a subsequent study of those infants at 2 years of age (Mestan et. al. 2005) was that premature infants treated with inhaled nitric oxide (iNO) have improved neurodevelopmental outcomes and physical growth at 2 years corrected age, compared with placebo-treated infants (Mestan et. al. 2005). INO therapy, therefore, appears to be a new treatment to protect the premature brain during development outside the womb. The overall goal of this application is understand the efficacy of iNO treatment in improving neurodevelopmental outcomes in at-risk premature infants.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INO Control (Short iNO) | Placebo Comparator | INO will be given to infants in the control group for the first 7 days of the study gas, then O2 or room air, as clinically appropriate, on the 8th day, until 33 weeks corrected age |
|
| INO Treatment (Long iNO) | Experimental | The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhaled nitric oxide | Drug | The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurodevelopment | Two years | |
| Bronchopulmonary Dysplasia (BPD) or Death | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations >90%, or death before discharge | 36 weeks of age corrected (BPD) or before discharge (death) |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Death before discharge | through discharge (up to 400 days) |
| Bronchopulmonary Dysplasia | Need for respiratory support at 36 weeks post-menstrual age (PMA), either as positive pressure or supplemental oxygen to maintain oxygen saturations >90% |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael D. Schreiber, M.D. | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14645637 | Background | Schreiber MD, Gin-Mestan K, Marks JD, Huo D, Lee G, Srisuparp P. Inhaled nitric oxide in premature infants with the respiratory distress syndrome. N Engl J Med. 2003 Nov 27;349(22):2099-107. doi: 10.1056/NEJMoa031154. | |
| 16000353 | Background | Mestan KK, Marks JD, Hecox K, Huo D, Schreiber MD. Neurodevelopmental outcomes of premature infants treated with inhaled nitric oxide. N Engl J Med. 2005 Jul 7;353(1):23-32. doi: 10.1056/NEJMoa043514. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | INO Control (Short iNO) | INO will be given to infants in the control group for the first 7 days of the study gas, then O2 or room air, as clinically appropriate, on the 8th day, until 33 weeks corrected age inhaled nitric oxide: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm. |
| FG001 | INO Treatment (Long iNO) | The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age. inhaled nitric oxide: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm. oxygen: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of the subject's lungs. Subjects in the control arm of the study will receive oxygen beginning on the 8th day of the study until he/she reaches 33 weeks of gestation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | INO Control (Short iNO) | INO will be given to infants in the control group for the first 7 days of the study gas, then O2 or room air, as clinically appropriate, on the 8th day, until 33 weeks corrected age inhaled nitric oxide: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm. |
| 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 |
| 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 | Neurodevelopment | Data were not collected (due to funding cuts). | Posted | Two years |
|
through discharge (up to 400 days)
Standard perinatal morbidities were tracked and reported and all are considered serious adverse events (SAEs). Non-serious adverse events were not defined or tracked.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INO Control (Short iNO) | INO will be given to infants in the control group for the first 7 days of the study gas, then O2 or room air, as clinically appropriate, on the 8th day, until 33 weeks corrected age inhaled nitric oxide: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe IVH/PVL | Vascular disorders | Systematic Assessment | Severe intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL) |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael D. Schreiber, MD | University of Chicago | 773-702-6205 | mschreiber@bsd.uchicago.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 10, 2017 | Oct 15, 2024 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001997 | Bronchopulmonary Dysplasia |
| D007969 | Leukomalacia, Periventricular |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| oxygen | Drug | The amount of gas will be carefully controlled and adjusted to the level that best improves the function of the subject's lungs. Subjects in the control arm of the study will receive oxygen beginning on the 8th day of the study until he/she reaches 33 weeks of gestation. |
|
|
| 36 weeks of age corrected |
| Supplemental Oxygen Use | 40 weeks PMA |
| BPD or Death in Infants Weighing < 750g | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations >90%, or death before discharge among infants < 750g | 36 weeks of age corrected (BPD) or before discharge (death) |
| BPD or Death in Infants Weighing 750-999g | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations >90%, or death before discharge among infants 750-999g | 36 weeks of age corrected (BPD) or before discharge (death) |
| BPD or Death in Black Infants | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations >90%, or death before discharge among Black infants | 36 weeks of age corrected (BPD) or before discharge (death) |
| BG001 | INO Treatment (Long iNO) | The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age. inhaled nitric oxide: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm. oxygen: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of the subject's lungs. Subjects in the control arm of the study will receive oxygen beginning on the 8th day of the study until he/she reaches 33 weeks of gestation. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Bronchopulmonary Dysplasia (BPD) or Death | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations >90%, or death before discharge | Posted | Count of Participants | Participants | 36 weeks of age corrected (BPD) or before discharge (death) |
|
|
|
|
| Secondary | Death | Death before discharge | Posted | Count of Participants | Participants | through discharge (up to 400 days) |
|
|
|
|
| Secondary | Bronchopulmonary Dysplasia | Need for respiratory support at 36 weeks post-menstrual age (PMA), either as positive pressure or supplemental oxygen to maintain oxygen saturations >90% | Posted | Count of Participants | Participants | 36 weeks of age corrected |
|
|
|
|
| Secondary | Supplemental Oxygen Use | Posted | Count of Participants | Participants | 40 weeks PMA |
|
|
|
|
| Secondary | BPD or Death in Infants Weighing < 750g | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations >90%, or death before discharge among infants < 750g | Posted | Count of Participants | Participants | 36 weeks of age corrected (BPD) or before discharge (death) |
|
|
|
|
| Secondary | BPD or Death in Infants Weighing 750-999g | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations >90%, or death before discharge among infants 750-999g | Posted | Count of Participants | Participants | 36 weeks of age corrected (BPD) or before discharge (death) |
|
|
|
|
| Secondary | BPD or Death in Black Infants | Need for respiratory support at 36 weeks post-menstrual age, either as positive pressure or supplemental oxygen to maintain oxygen saturations >90%, or death before discharge among Black infants | Posted | Count of Participants | Participants | 36 weeks of age corrected (BPD) or before discharge (death) |
|
|
|
|
| 19 |
| 138 |
| 53 |
| 138 |
| 0 |
| 0 |
| EG001 | INO Treatment (Long iNO) | The treatment group will receive iNO, combined with O2 or room air, until 33 weeks corrected age. inhaled nitric oxide: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of subject's lungs. The subject will remain on inhaled nitric oxide until he/she reaches 33 weeks of gestation if assigned to the treatment arm, or until the 8th day of the study if he/she is assigned to the control arm. oxygen: The amount of gas will be carefully controlled and adjusted to the level that best improves the function of the subject's lungs. Subjects in the control arm of the study will receive oxygen beginning on the 8th day of the study until he/she reaches 33 weeks of gestation. | 13 | 135 | 61 | 135 | 0 | 0 |
|
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Acute bleeding from the lung, from the upper respiratory tract and the trachea, and the pulmonary alveoli. |
|
| Pneumorthorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Collapsed lung |
|
| Pulmonary interstitial emphysema (PIE) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | A condition where air dissects through alveolar walls into the adjacent interstitial tissues where it forms cystic spaces with an associated inflammatory reaction. |
|
| Symptomatic patent ductus arteriosis (PDA) | Cardiac disorders | Systematic Assessment | An opening between the two main vessels leading to the heart |
|
| Necrotizing enterocolitis (NEC) of Bell's stage 2 severity or greater | Gastrointestinal disorders | Systematic Assessment | Inflammatory disease of the newborn bowel. |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| 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 |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004678 | Encephalomalacia |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |