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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HD113837-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease.
Infants born between 22.0 to 31.6 weeks' gestational age with bronchopulmonary dysplasia associated pulmonary hypertension, are receiving supplemental oxygen, and have mature retinas will be randomized to SpO2 targets of either (1) 92-95% (control) or (2) 95-98% (intervention).
Using a cross over design with a 1:1 parallel allocation of infants randomized using a stratified permuted block design. Following 1week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period. Bedside providers will follow pre-specified algorithms to maintain oxygen targets during the randomization period. Reports of oxygen saturation performance will also be provided to bedside providers through oxygen saturation histograms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxygen saturation target 92-95% | Active Comparator | At UAB and Yale oxygen saturation targeting is achieved using systematic oxygen saturation histogram monitoring every 3-4 hours by nurse, respiratory therapists, and physicians. Upon randomization to this arm, infants oxygen saturation alarm limits will be adjusted to 92-95% after which an FiO2 modification algorithm will be employed to maintain targets. Daily compliance reports will be generated to ensure oxygen saturation achievement corresponds with oxygen saturation targets. Infants will be exposed to a 1 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets. |
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| Oxygen saturation target 95-98% | Active Comparator | At UAB and Yale oxygen saturation targeting is achieved using systematic oxygen saturation histogram monitoring every 3-4 hours by nurse, respiratory therapists, and physicians. Upon randomization to this arm, infants oxygen saturation alarm limits will be adjusted to 95-98% after which an FiO2 modification algorithm will be employed to maintain targets. Daily compliance reports will be generated to ensure oxygen saturation achievement corresponds with oxygen saturation targets. Infants will be exposed for a 1 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| higher oxygen saturation target using Nellcor pulse oximetry sensors | Device | The intervention will be a cross over exposure to the higher oxygen saturation target. |
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| Measure | Description | Time Frame |
|---|---|---|
| Intermittent hypoxemia event duration | The average duration of time (in seconds) an infant's oxygen saturation decrease below 80%. | From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiographic shunting | >20% flow of blood across the PDA from the pulmonary to arterial circulation | through study completion, 3 weeks from date of randomization until 3 weeks have elapsed or date of discharge, whichever came first |
| Echocardiographic interventricular septal flattening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel Gentle, MD | Contact | 205-541-2247 | samjgentle@gmail.com | |
| Colm Travers | Contact | samuel.gentle@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Samuel Gentle | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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Single center, randomized cross-over pilot study with a 1:1 parallel allocation of infants to SpO2 targets of 92-95% (control) and 95-98% (intervention) using a stratified permuted block design. Following 1 week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period.
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The PI will perform bedside echocardiography precluding masking to group allocation. All echocardiograms will be further reviewed by a cardiologist masked to group allocation with additional cardiologist review in instances of disagreement. Inter-rater reliability testing will also be performed.
| lower oxygen saturation target using Nellcor pulse oximetry sensors | Device | The intervention will be a cross over exposure to the lower oxygen saturation target. |
|
End-systolic flattening of the interventricular septum (eccentricity index >1.3) |
| From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first |
| Echocardiographic tricuspid regurgitation | Right ventricular pressure estimates | From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first |
| Intermittent hypoxemia frequency | Number of daily events during which an infant's oxygen saturation decreases below 80% | From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first |
| Cumulative hypoxemia | Daily duration during which an infant's oxygen saturation is <80% | From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first |
| Brain natriuretic peptide | A polypeptide released from the cardiac ventricles indicative of right heart strain | From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first |
| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D006976 | Hypertension, Pulmonary |
| 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 |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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