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| ID | Type | Description | Link |
|---|---|---|---|
| U10HD034216 | U.S. NIH Grant/Contract | View source | |
| U10HD034167 | U.S. NIH Grant/Contract | View source | |
| U10HD021397 | U.S. NIH Grant/Contract | View source | |
| U10HD027853 | U.S. NIH Grant/Contract | View source | |
| U10HD027871 | U.S. NIH Grant/Contract | View source | |
| U10HD021415 | U.S. NIH Grant/Contract | View source | |
| U10HD027904 | U.S. NIH Grant/Contract | View source | |
| U10HD027881 | U.S. NIH Grant/Contract | View source | |
| U10HD021385 | U.S. NIH Grant/Contract | View source | |
| U10HD027851 | U.S. NIH Grant/Contract | View source | |
| U10HD027880 | U.S. NIH Grant/Contract | View source | |
| U10HD021373 | U.S. NIH Grant/Contract | View source | |
| U01HD036790 | U.S. NIH Grant/Contract | View source | |
| M01RR008084 | U.S. NIH Grant/Contract | View source | |
| M01RR006022 | U.S. NIH Grant/Contract | View source | |
| M01RR000750 | U.S. NIH Grant/Contract | View source | |
| M01RR000997 | U.S. NIH Grant/Contract | View source | |
| M01RR000070 | U.S. NIH Grant/Contract | View source | |
| M01RR001032 | U.S. NIH Grant/Contract | View source |
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The trial was halted because of unanticipated nonrespiratory adverse events related to dexamethasone therapy.
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide [PCO(2)] target >52 mm Hg) or routine ventilation (PCO(2) target <48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge. The infants' neurodevelopment was evaluated at 18-22 months corrected age.
Chronic lung disease (CLD), also known as bronchopulmonary dysplasia (BPD), in very premature infants has been associated with mechanical ventilation and relative adrenal insufficiency.
This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide [PCO(2)] target >52 mm Hg) or routine ventilation (PCO(2) target <48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge.
The trial was terminated by the Steering Committee when the interim analysis for the Data Safety and Monitoring Committee showed a higher rate of spontaneous gastrointestinal perforations in the dexamethasone-treated infants.
Neurodevelopment was assessed at 18-22 months postmenstrual age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimal ventilation with Dexamethasone | Experimental | Minimal ventilator support strategy (permissive hypercapnia) and early stress dose dexamethasone therapy |
|
| Minimal Ventilation without Dexamethasone | Experimental | Minimal ventilator support strategy (permissive hypercapnia) and no dexamethasone therapy |
|
| Routine ventilation with Dexamethasone | Active Comparator |
| |
| Routine ventilation without Dexamethasone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal mechanical ventilation management | Procedure | Partial pressure of carbon dioxide (PCO2) target (>52 mm Hg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death or moderate to severe bronchopulmonary dysplasia | 36 weeks postmenstrual age |
| Measure | Description | Time Frame |
|---|---|---|
| Death | 36 weeks postmenstrual age | |
| Mechanical ventilation | 36 weeks postmenstrual age | |
| Pulmonary interstitial emphysema |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waldemar A. Carlo, MD | University of Alabama at Birmingham | Study Director |
| Ann R. Stark, MD | Brigham and Women's Hospital | Study Director |
| William Oh, MD | Brown University, Women & Infants Hospital | Principal Investigator |
| Avroy A. Fanaroff, MD | Case Western Reserve University, Rainbow Babies & Children's Hospital | Principal Investigator |
| Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Barbara J. Stoll, MD | Emory University | Principal Investigator |
| Charles R. Bauer, MD | University of Miami | Principal Investigator |
| Lu-Ann Papile, MD | University of New Mexico | Study Director |
| David K. Stevenson, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12219057 | Result | Carlo WA, Stark AR, Wright LL, Tyson JE, Papile LA, Shankaran S, Donovan EF, Oh W, Bauer CR, Saha S, Poole WK, Stoll B. Minimal ventilation to prevent bronchopulmonary dysplasia in extremely-low-birth-weight infants. J Pediatr. 2002 Sep;141(3):370-4. doi: 10.1067/mpd.2002.127507. | |
| 11150359 | Result | Stark AR, Carlo WA, Tyson JE, Papile LA, Wright LL, Shankaran S, Donovan EF, Oh W, Bauer CR, Saha S, Poole WK, Stoll BJ; National Institute of Child Health and Human Development Neonatal Research Network. Adverse effects of early dexamethasone treatment in extremely-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med. 2001 Jan 11;344(2):95-101. doi: 10.1056/NEJM200101113440203. |
| Label | URL |
|---|---|
| NICHD Neonatal Research Network | View source |
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| Routine mechanical ventilation management | Procedure | Partial pressure of carbon dioxide (PCO2) target <48 mm Hg) |
|
| Dexamethasone | Drug | Treatment with the study medication was initiated within 24 hours after birth. The dexamethasone-treated infants received a 10-day tapered course (0.15 mg of dexamethasone per kilogram per day for three days, followed by 0.10 mg per kilogram for three days, 0.05 mg per kilogram for two days, and 0.02 mg per kilogram for two days), with the daily dose divided in half and given at 12-hour intervals intravenously or orally, if an intravenous catheter was no longer in place. |
|
| Placebo | Drug | The infants in the placebo groups received equal volumes of saline. |
|
|
| 36 weeks postmenstrual age |
| Pneumothorax | 36 weeks postmenstrual age |
| Open-label steroids | 36 weeks postmenstrual age |
| Reintubation | 36 weeks postmenstrual age |
| Intracranial hemorrhage (IVH) III or IV | 36 weeks postmenstrual age |
| Periventricular leukomalacia | 36 weeks postmenstrual age |
| Necrotizing enterocolitis | 36 weeks postmenstrual age |
| Duration of oxygen supplementation | 36 weeks postmenstrual age |
| Duration of ventilation | 36 weeks postmenstrual age |
| Length of hospitalization | Hospital discharge |
| Death or neurodevelopmental impairment | 18-22 months corrected age |
| Death | 18-22 months corrected age |
| Neurodevelopmental impairment | 18-22 months corrected age |
| Cerebral palsy | 18-22 months corrected age |
| Bilateral blindness | 18-22 months corrected age |
| Deafness | 18-22 months corrected age |
| Bayley Scales of Infant Development-Revised II Psychomotor Developmental Index (PDI) | 18-22 months corrected age |
| Rehospitalizations | 18-22 months corrected age |
| Sheldon B. Korones, MD |
| University of Tennessee |
| Principal Investigator |
| Jon E. Tyson, MD MPH | University of Texas Southwestern Medical Center | Principal Investigator |
| Seetha Shankaran, MD | Wayne State University | Principal Investigator |
| Richard A. Ehrenkranz, MD | Yale University | Principal Investigator |
| W. Kenneth Poole, PhD | RTI International | Principal Investigator |
| Palo Alto |
| California |
| 94304 |
| United States |
| Yale University | New Haven | Connecticut | 06504 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| RTI International | Durham | North Carolina | 27705 | United States |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| University of Tennessee | Memphis | Tennessee | 38163 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D012128 | Respiratory Distress Syndrome |
| D047928 | Premature Birth |
| D053120 | Respiratory Aspiration |
| D012131 | Respiratory Insufficiency |
| 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 |
| D012120 | Respiration Disorders |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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