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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00005774 |
Purpose
Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. To test whether they might benefit from early surfactant, infants who weigh 1250 to 2000 grams and have respiratory distress syndrome will be randomized to either receive surfactant as soon as possible after randomization, followed by extubation within 30 minutes and continuous positive airway pressure (CPAP) or surfactant according to the usual practice of the center. This trial will evaluate whether in infants with mild to moderate respiratory distress syndrome, early administration of surfactant followed by extubation within 30 minutes and the use of CPAP reduces the need for subsequent mechanical ventilation.
| Condition | Intervention | Phase |
|---|---|---|
|
Infant, Newborn, Diseases Respiratory Distress Syndrome Respiratory Insufficiency |
Drug: Survanta Procedure: Continuous positive airway pressure |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Immediate Extubation After the First Dose of Surfactant to Reduce the Use of Mechanical Ventilation |
| Estimated Enrollment: | 560 |
| Study Start Date: | May 2000 |
The role of surfactant therapy in the management of the larger infant with respiratory distress syndrome (RDS) remains unclear. In many neonatal intensive care units, these infants are routinely managed with CPAP alone. This trial will address whether early use of surfactant combined with CPAP will ameliorate the course of RDS without an increase in morbidity. Although the primary study outcomes are measures of use of mechanical ventilation, the focus of the study is not reduction in use of resources, but rather reduction in ventilator use and thereby likely reduction in risk of ventilator-associated morbidity.
Eligible infants will be randomized either to the intervention or control group. Infants in the intervention group will be treated with early surfactant followed by extubation within 30 minutes and application of CPAP. Infants in the control group will receive surfactant according to current center practice, only after initiation of mechanical ventilation. Randomization will be done as soon as possible after verification of eligibility, before the infant is 12 hours of age. Randomization will be stratified by clinical center and by birth weight.
The sample size of 560 infants (280 each in control and treatment groups) is based on an assumption of a relative risk reduction of 30 percent in ventilator use comparing the control and surfactant groups. A test with 80 percent power and 5 percent alpha level (two-tailed).
Eligibility| Ages Eligible for Study: | up to 12 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33101 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30335 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Rhode Island | |
| Women and Infants Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| University of Texas | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Edward F. Donovan, MD | University of Cincinnati |
| Principal Investigator: | Ann R. Stark, MD | Children's Hospital |
More Information
| Study ID Numbers: | NICHD-1006, U10 HD27856, U10 HD21364, U10 HD34216, U10 HD34167, U10 HD21397, U10 HD27853, U10 HD27871, U10 HD21415, U10 HD27904, U10 HD27881, U10 HD21385, U10 HD27851, U10 HD27880, U01 HD36790, M01 RR08084, M01 RR06022, M01 RR00750, M01 RR00997, M01 RR00070, M01 RR01032 |
| Study First Received: | June 1, 2000 |
| Last Updated: | February 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00005774 History of Changes |
| Health Authority: | United States: Federal Government |
|
Infant, newborn, diseases Infant, premature, disease / therapy Pulmonary ventilation Respiratory distress syndrome |
Respiratory insufficiency Surfactant, pulmonary Ventilation, mechanical |
|
Body Weight Birth Weight Respiratory Insufficiency Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Respiratory Distress Syndrome, Adult Acute Respiratory Distress Syndrome Infant, Newborn, Diseases Infant, Premature, Diseases Beractant Pulmonary Surfactants |
|
Respiratory System Agents Disease Respiratory Distress Syndrome, Adult Respiration Disorders Pharmacologic Actions Respiratory Insufficiency Pathologic Processes |
Respiratory Tract Diseases Syndrome Lung Diseases Therapeutic Uses Infant, Newborn, Diseases Pulmonary Surfactants |
