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Perfusion Index Variability in Respiratory Distress Syndrome

D

Dr. Sami Ulus Children's Hospital

Status

Completed

Conditions

Poor Peripheral Perfusion

Treatments

Drug: Poractant alfa
Drug: Beractant

Study type

Interventional

Funder types

Other

Identifiers

NCT01852461
685.114A
Surfactant trial (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

92 patients

Sex

All

Ages

1 to 3 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • premature infants < 32 weeks of gestational age

Exclusion criteria

  • congenital malformation
  • Apgar scores <3 at 5 min

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

92 participants in 2 patient groups

Beractant
Active Comparator group
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
Treatment:
Drug: Beractant
Poractant alfa
Active Comparator group
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
Treatment:
Drug: Poractant alfa

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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