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Home > "E" Clinical Trials Conditions > Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants  Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
For Condition: Respiratory Distress Syndrome,Respiratory Insufficiency,Infant, Newborn, Diseases
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: /12 Hours
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Birth weight 1250 to 2000 grams - Age less than 12 hours - Clinical and radiographic diagnosis of respiratory distress syndrome (RDS) - Receiving supplemental oxygen with head-hood Fi02 of 0.35 to 0.50 or CPAP Fi02 of 0.25 to 0.50 to maintain oxygen saturation less than 90 percent and more than 96 percent Exclusion Criteria: - Receiving mechanical ventilation - Air leak - Pulmonary hemorrhage - Major congenital anomaly - Congenital non-bacterial infection - Parental refusal of consent - Refusal of attending neonatologist
Total Enrollment: 560
Location and Contact Information:
Overall Study Official:
EdwardDonovan, Principal Investigator, University of Cincinnati
University of Tennessee
Memphis, Tennessee, 38163
United States
University of Alabama
Birmingham, Alabama, 35294
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
Stanford University
Palo Alto, California, 94304
United States
Wayne State University
Detroit, Michigan, 48201
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
Women and Infants Hospital
Providence, Rhode Island, 02903
United States
University of Texas
Houston, Texas, 77030
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Emory University
Atlanta, Georgia, 30335
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
University of Miami
Miami, Florida, 33101
United States
Yale University
New Haven, Connecticut, 06520
United States
Additional Information:
Study ID Numbers: NICHD-1006; U10 HD27851,M01 RR00750,M01 RR00070,M01 RR01032,U10 HD21385,U10 HD27880,U10 HD34167,U10 HD27853,U10 HD27904,U10 HD27856,U01 HD36790,M01 RR06022,U10 HD21397,U10 HD21415,U10 HD34216,M01 RR00997,U10 HD27881,U10 HD27871,U10 HD21364,M01 RR08084
Study Start Date: May 2000
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005774
Other Respiratory Distress Syndrome Studies:
1. Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
2. Study of Morphine in Postoperative Infants to Allow Normal Ventilation
3. Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants
4. Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
5. Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.
Related Studies:
Other Respiratory Distress Syndrome Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
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