Back to resultsPerfusion Index Variability in Respiratory Distress Syndrome
Primary Purpose
Poor Peripheral Perfusion
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Beractant
Poractant alfa
Sponsored by
About this trial
This is an interventional treatment trial for Poor Peripheral Perfusion focused on measuring natural surfactants; perfusion index
Eligibility Criteria
Inclusion Criteria:
- premature infants < 32 weeks of gestational age
Exclusion Criteria:
- congenital malformation
- Apgar scores <3 at 5 min
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Beractant
Poractant alfa
Arm Description
Beractant;bovine lung extract; both initial and subsequent dosing is 100 mg/kg (4 mL/kg), which may be given every 6 hours up to four total doses
Poractant alfa; porcine lung extract; initial dosing is 200 mg/kg (2.5 mL/kg) and repeated dosing is given at 100 mg/kg (1.25 mL/kg) every 12 hours, up to maximum of two additional doses when indicated
Outcomes
Primary Outcome Measures
perfusion index
PI and oxygen saturation (SpO2) were measured by "Masimo Rainbow SET Radical-7 pulse oximeter" before and after surfactant. The effects of the two treatment regimens on PI, oxygenation and clinical outcome were compared.
Secondary Outcome Measures
Duration of mechanical ventilation
The effects of the two treatment regimens on duration of mechanical ventilation were compared
Full Information
NCT ID
NCT01852461
First Posted
May 7, 2013
Last Updated
May 10, 2013
Sponsor
Dr. Sami Ulus Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01852461
Brief Title
Perfusion Index Variability in Respiratory Distress Syndrome
Official Title
Perfusion Index Variability in Preterm Infants Treated With Two Different Natural Surfactants for Respiratory Distress Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Sami Ulus Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Perfusion index may vary according to type of surfactant during the treatment of respiratory distress syndrome.
Detailed Description
Peripheral tissues of preterm infants are very sensitive for hypoperfusion, but there are rare data in the literature for peripheral perfusion after surfactant treatment. In this study the investigators aimed to compare the perfusion index (PI) variability in premature infants with respiratory distress (RDS) following instillation of one of two different natural surfactant preparations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poor Peripheral Perfusion
Keywords
natural surfactants; perfusion index
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Beractant
Arm Type
Active Comparator
Arm Description
Beractant;bovine lung extract; both initial and subsequent dosing is 100 mg/kg (4 mL/kg), which may be given every 6 hours up to four total doses
Arm Title
Poractant alfa
Arm Type
Active Comparator
Arm Description
Poractant alfa; porcine lung extract; initial dosing is 200 mg/kg (2.5 mL/kg) and repeated dosing is given at 100 mg/kg (1.25 mL/kg) every 12 hours, up to maximum of two additional doses when indicated
Intervention Type
Drug
Intervention Name(s)
Beractant
Other Intervention Name(s)
Beractant (Survanta)
Intervention Description
Beractant;both initial and subsequent dosing is 100 mg/kg (4 mL/kg), which may be given every 6 hours up to four total doses
Intervention Type
Drug
Intervention Name(s)
Poractant alfa
Other Intervention Name(s)
Poractant alfa (curosurf)
Intervention Description
porcine lung extract, initial dosing is 200 mg/kg (2.5 mL/kg) and repeated dosing is given at 100 mg/kg (1.25 mL/kg) every 12 hours, up to maximum of two additional doses when indicated
Primary Outcome Measure Information:
Title
perfusion index
Description
PI and oxygen saturation (SpO2) were measured by "Masimo Rainbow SET Radical-7 pulse oximeter" before and after surfactant. The effects of the two treatment regimens on PI, oxygenation and clinical outcome were compared.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation
Description
The effects of the two treatment regimens on duration of mechanical ventilation were compared
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Mortality
Description
The effects of the two treatment regimens on mortality were compared
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
premature infants < 32 weeks of gestational age
Exclusion Criteria:
congenital malformation
Apgar scores <3 at 5 min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek Dilli, Assoc Prof
Organizational Affiliation
Sami Ulus CH
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Perfusion Index Variability in Respiratory Distress Syndrome
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