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	Treatment or Intervention	Phase
Infant, Newborn, Diseases Respiratory Distress Syndrome Respiratory Insufficiency	Drug: Survanta  Procedure: Continuous positive airway pressure	Phase III

Further Study Details: 

Expected Total Enrollment:  560

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).

Ages Eligible for Study:  up to  12 Hours,  Genders Eligible for Study:  Both

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

Alabama
      University of Alabama, Birmingham,  Alabama,  35294,  United States
California
      Stanford University, Palo Alto,  California,  94304,  United States
Connecticut
      Yale University, New Haven,  Connecticut,  06520,  United States
Florida
      University of Miami, Miami,  Florida,  33101,  United States
Georgia
      Emory University, Atlanta,  Georgia,  30335,  United States
Indiana
      Indiana University, Indianapolis,  Indiana,  46202,  United States
Michigan
      Wayne State University, Detroit,  Michigan,  48201,  United States
New Mexico
      University of New Mexico, Albuquerque,  New Mexico,  87131,  United States
Ohio
      Case Western Reserve Univ, Cleveland,  Ohio,  44106,  United States
      University of Cincinnati, Cincinnati,  Ohio,  45267,  United States
Rhode Island
      Women and Infants Hospital, Providence,  Rhode Island,  02903,  United States
Tennessee
      University of Tennessee, Memphis,  Tennessee,  38163,  United States
Texas
      University of Texas, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Edward F. Donovan, MD,  Principal Investigator,  University of Cincinnati   
Ann R. Stark, MD,  Principal Investigator,  Children's Hospital   

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
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  June 1, 2000
ClinicalTrials.gov Identifier:  NCT00005774
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08