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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 1, 2000 | ||||||||
| Last Updated Date | February 21, 2007 | ||||||||
| Start Date ICMJE | May 2000 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00005774 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants | ||||||||
| Official Title ICMJE | Immediate Extubation After the First Dose of Surfactant to Reduce the Use of Mechanical Ventilation | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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). |
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| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | Verder H, Robertson B, Greisen G, Ebbesen F, Albertsen P, Lundstrom K, Jacobsen T. Surfactant therapy and nasal continuous positive airway pressure for newborns with respiratory distress syndrome. Danish-Swedish Multicenter Study Group. N Engl J Med. 1994 Oct 20;331(16):1051-5. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 560 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 12 Hours | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00005774 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 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 Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Verification Date | March 2003 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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