Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome
Primary Purpose
Respiratory Distress Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Curosurf®
Survanta®
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Major congenital anomaly
- Sepsis syndrome in extremis
Sites / Locations
- University of Michigan C & W Mott Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Survanta®
Curosurf®
Arm Description
Survanta® (Beractant, Abbot Laboratories, Columbus, OH) Surfactant will be administered by respiratory therapist not involved in patient's care.
Curosurf® (Cornerstone Therapeutics, Inc., Cary, NC Surfactant will be administered by respiratory therapist not involved in patient's care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01537354
First Posted
February 13, 2012
Last Updated
January 7, 2014
Sponsor
University of Michigan
Collaborators
Cornerstone Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01537354
Brief Title
Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome
Official Title
A Comparison of Immediate Changes in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor discontinued clinical trial before enrollment of subjects.
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Cornerstone Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Premature newborn infants may have impaired lung function as a result of their prematurity. When this occurs, the newborns show poor oxygen and carbon dioxide exchange and difficulty in breathing. The reason for these symptoms is due in part to the lack of special chemicals in the lungs, called phospholipids or surfactant. The lack of these special chemicals causes the babies lung to be difficult to ventilate. Treatment of this condition can require placing an artificial airway (endotracheal tube) into the babies windpipe (intubation) and use of a breathing machine (ventilator). In addition, physicians frequently give these special chemicals (phospholipid) through the childs airway. There are several different types of phospholipids available for this treatment in newborns but very limited amount of studies have been done to examine differences in the ability to ventilate between the various types of surfactant. The investigators propose to examine immediate changes in ability to ventilate (dynamic compliance) at specific time intervals after administration of either type of surfactant; Curosurf or Survanta.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Survanta®
Arm Type
Active Comparator
Arm Description
Survanta® (Beractant, Abbot Laboratories, Columbus, OH) Surfactant will be administered by respiratory therapist not involved in patient's care.
Arm Title
Curosurf®
Arm Type
Active Comparator
Arm Description
Curosurf® (Cornerstone Therapeutics, Inc., Cary, NC Surfactant will be administered by respiratory therapist not involved in patient's care.
Intervention Type
Drug
Intervention Name(s)
Curosurf®
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Survanta®
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in dynamic compliance
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Minutes
Maximum Age & Unit of Time
12 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Major congenital anomaly
Sepsis syndrome in extremis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Donn, M.D.
Organizational Affiliation
University of Michigan C & W Mott Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan C & W Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0245
Country
United States
12. IPD Sharing Statement
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Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome
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