Perfusion Index Variability in Respiratory Distress Syndrome

NCT ID: NCT01852461

Last Updated: 2013-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-12-31

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.

Conditions

Poor Peripheral Perfusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Beractant

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

Group Type: ACTIVE_COMPARATOR

Beractant

Intervention Type: DRUG

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

Poractant alfa

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

Group Type: ACTIVE_COMPARATOR

Poractant alfa

Intervention Type: DRUG

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

Interventions

Beractant

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

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

Other Intervention Names

Beractant (Survanta); Poractant alfa (curosurf)

Eligibility Criteria

Inclusion Criteria

• premature infants < 32 weeks of gestational age

Exclusion Criteria

• congenital malformation
• Apgar scores <3 at 5 min

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Sami Ulus Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dilek Dilli

Assos Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dilek Dilli, Assoc Prof

Role: STUDY_DIRECTOR

Sami Ulus CH

Other Identifiers

Surfactant trial

Identifier Type: OTHER

Identifier Source: secondary_id

685.114A

Identifier Type: -

Identifier Source: org_study_id