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| ID | Type | Description | Link |
|---|---|---|---|
| U10HD027856 | U.S. NIH Grant/Contract | View source | |
| U10HD021364 | U.S. NIH Grant/Contract | View source | |
| 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 | |
| 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 stopped after 7 months for lack of recruitment.
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. The role of surfactant therapy in the management of larger infants with respiratory distress syndrome (RDS) was unclear. In many neonatal intensive care units, these infants were routinely managed with continuous positive airway pressure (CPAP) alone.
This trial tested whether early use of surfactant combined with CPAP would ameliorate the course of RDS without an increased risk of death. Primary study outcomes were measures of use of mechanical ventilation, and thereby likely reduction in risk of ventilator-associated morbidity.
Eligible infants were randomized before the infant is 12 hours of age to receive either: early surfactant followed by extubation within 30 minutes and application of CPAP (intervention group); or surfactant according to current center practice, only after initiation of mechanical ventilation (control group).
The trial was stopped after 7 months for lack of recruitment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early surfactant group | Experimental |
| |
| Standard Practice group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early surfactant | Drug | Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need for mechanical ventilation following randomization | Until hospital discharge or 120 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Mean duration of mechanical ventilation | Until hospital discharge or 120 days of life | |
| Risk morbidities associated with mechanical ventilation and/or early surfactant administration | Until hospital discharge or 120 days of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | Study Director |
| David K. Stevenson, MD | Stanford University | Principal Investigator |
| Waldemar A. Carlo, MD | University of Alabama at Birmingham | Principal Investigator |
| Richard A. Ehrenkranz, MD | Yale University | Principal Investigator |
| Barbara J. Stoll, MD | Emory University | Principal Investigator |
| James A. Lemons, MD | Indiana University | Principal Investigator |
| Charles R. Bauer, MD | University of Miami | Principal Investigator |
| Lu-Ann Papile, MD | University of New Mexico | Principal Investigator |
| Seetha Shankaran, MD | Wayne State University | Principal Investigator |
| Avroy A. Fanaroff, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Stanford University |
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| Label | URL |
|---|---|
| NICHD Neonatal Research Network | View source |
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|
| Standard practice | Drug | Surfactant according to current center practice, only after initiation of mechanical ventilation. |
|
| Case Western Reserve University, Rainbow Babies and Children's Hospital |
| Principal Investigator |
| William Oh, MD | Brown University, Women & Infants Hospital of Rhode Island | Principal Investigator |
| Sheldon B. Korones, MD | University of Tennessee | Principal Investigator |
| Jon E. Tyson, MD MPH | The University of Texas Health Science Center, Houston | 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 |
| 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 |
| 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 Health Science Center at Houston | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| C072197 | beractant |
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