Study Stopped
Sponsor discontinued clinical trial before enrollment of subjects.
Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome
A Comparison of Immediate Changes in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This is a null hypothesis study. The investigators hypothesize that there will be no difference in changes in dynamic compliance when measured at 15, 30, 45 and 60 minute intervals after administration of either surfactant and there will be no differences in the number of doses needed between the two surfactants in premature infants admitted to our NICU.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2012
CompletedFirst Posted
Study publicly available on registry
February 23, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedJanuary 8, 2014
January 1, 2014
1.5 years
February 13, 2012
January 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in dynamic compliance
Patient's dynamic compliance will be measured immediately after initial dosage, q15 minutes for 60 minutes and hourly for 48 hrs as long as intubated.
15 minutes, 30 minutes, 45 minutes and then hourly intervals after administration of surfactant. Subjects' compliance will be monitored hourly after the first 60 minutes while they are being ventilated in the Neonatal Intensive Care Unit.
Study Arms (2)
Survanta®
ACTIVE COMPARATORSurvanta® (Beractant, Abbot Laboratories, Columbus, OH) Surfactant will be administered by respiratory therapist not involved in patient's care.
Curosurf®
ACTIVE COMPARATORCurosurf® (Cornerstone Therapeutics, Inc., Cary, NC Surfactant will be administered by respiratory therapist not involved in patient's care.
Interventions
Initial dose is 2.5ml/kg (200 mg/kg phospholipid) administered via endotracheal tube. Subsequent doses if needed are 1.25 mL/kg (100 mg/kg phospholipids).
Initial dose is 4 mL/kg (100 mg/kg phospholipids) administered via endotracheal tube. Subsequent doses if needed are 4 mL/kg (100 mg/kg phospholipids).
Eligibility Criteria
You may qualify if:
- Preterm infants between 28 and 31 6/7 weeks' gestational age
- Inborn to UM NICU
- \< 12 hours of age
- Respiratory Distress Syndrome
- radiographic evidence
- need for endotracheal intubation
- Oxygen requirement \> 30% FiO2
- Decision to give surfactant by the treatment team
You may not qualify if:
- Major congenital anomaly
- Sepsis syndrome in extremis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Cornerstone Pharmaceuticalscollaborator
Study Sites (1)
University of Michigan C & W Mott Children's Hospital
Ann Arbor, Michigan, 48109-0245, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Donn, M.D.
University of Michigan C & W Mott Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 13, 2012
First Posted
February 23, 2012
Study Start
June 1, 2012
Primary Completion
December 1, 2013
Last Updated
January 8, 2014
Record last verified: 2014-01