NCT01852461

Brief Summary

Perfusion index may vary according to type of surfactant during the treatment of respiratory distress syndrome.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
Last Updated

May 13, 2013

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

May 7, 2013

Last Update Submit

May 10, 2013

Conditions

Poor Peripheral Perfusion

Keywords

natural surfactants; perfusion index

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 week

Secondary Outcomes (1)

  • Duration of mechanical ventilation

    4 weeks

Other Outcomes (1)

  • Mortality

    4 weeks

Study Arms (2)

Beractant

ACTIVE COMPARATOR

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

Drug: Beractant

Poractant alfa

ACTIVE COMPARATOR

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

Drug: Poractant alfa

Interventions

BeractantDRUG

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

Also known as: Beractant (Survanta)
Beractant
Poractant alfaDRUG

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

Also known as: Poractant alfa (curosurf)
Poractant alfa

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • premature infants \< 32 weeks of gestational age

You may not qualify if:

  • congenital malformation
  • Apgar scores \<3 at 5 min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

beractantporactant alfa

Study Officials

  • Dilek Dilli, Assoc Prof

    Sami Ulus CH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos Prof

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 13, 2013

Study Start

August 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 13, 2013

Record last verified: 2013-05