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| ID | Type | Description | Link |
|---|---|---|---|
| U01HD019897 | U.S. NIH Grant/Contract | View source | |
| U10HD021364 | U.S. NIH Grant/Contract | View source | |
| U10HD021373 | U.S. NIH Grant/Contract | View source | |
| U10HD021385 | U.S. NIH Grant/Contract | View source | |
| U10HD021397 | U.S. NIH Grant/Contract | View source | |
| U10HD021415 | U.S. NIH Grant/Contract | View source | |
| U10HD027856 | U.S. NIH Grant/Contract | View source | |
| U10HD027853 | U.S. NIH Grant/Contract | View source | |
| U10HD027871 | U.S. NIH Grant/Contract | View source | |
| U10HD027851 | U.S. NIH Grant/Contract | View source | |
| U10HD027880 | U.S. NIH Grant/Contract | View source | |
| U10HD027881 | U.S. NIH Grant/Contract | View source |
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The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.
The NICHD Neonatal Research Network conducted a randomized trial at 11 centers comparing the efficacy of two surfactants -- Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories) -- for the treatment of neonatal respiratory distress syndrome. Newborn infants with birth weights of 501-1500g with respiratory distress syndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and January 1992. Infants were randomly assigned to receive up to four intratracheal doses of either Exosurf Neonatal or Survanta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surfactant 1 | Active Comparator | Exosurf Neonatal (Burroughs Wellcome Co.) |
|
| Surfactant 2 | Active Comparator | Survanta (Ross Laboratories) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exosurf | Drug | Infants received up to four intratracheal doses of the surfactant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death or bronchopulmonary dysplasia | 28 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Average fraction of inspired oxygen (FIO2) | 72 hours after treatment | |
| Mean airway pressure (MAP) | 72 hours after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey D. Horbar, MD | University of Vermont | Study Director |
| Elizabeth C. Wright, PhD | George Washington University | Principal Investigator |
| Avroy A. Fanaroff, MD | Case Western Reserve University | Principal Investigator |
| Sheldon B. Korones, MD | University of Tennessee | Principal Investigator |
| Seetha Shankaran, MD | Wayne State University | Principal Investigator |
| Charles R. Bauer, MD | University of Miami | Principal Investigator |
| Jon E. Tyson, MD MPH | University of Texas | Principal Investigator |
| James A. Lemons, MD | Indiana University | Principal Investigator |
| Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Barbara J. Stoll, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8229487 | Result | Horbar JD, Wright LL, Soll RF, Wright EC, Fanaroff AA, Korones SB, Shankaran S, Oh W, Fletcher BD, Bauer CR, et al. A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1993 Nov;123(5):757-66. doi: 10.1016/s0022-3476(05)80856-x. |
| Label | URL |
|---|---|
| NICHD Neonatal Research Network | View source |
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| Survanta | Drug | Infants received up to four intratracheal doses of the surfactant. |
|
|
| Emory University |
| Principal Investigator |
| David K. Stevenson, MD | Stanford University | Principal Investigator |
| LuAnn Papile, MD | University of New Mexico | Principal Investigator |
| New Haven |
| Connecticut |
| 06504 |
| United States |
| George Washington University | Washington D.C. | District of Columbia | 20052 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | 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 |
| University of Tennessee | Memphis | Tennessee | 38163 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| University of Vermont | Burlington | Vermont | 05405 | United States |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001997 | Bronchopulmonary Dysplasia |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| 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 |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| C047049 | dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combination |
| C072197 | beractant |
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