Perfusion Index Variability in Respiratory Distress Syndrome

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

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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