Perfusion Index Variability in Respiratory Distress Syndrome

Perfusion Index Variability in Preterm Infants Treated With Two Different Natural Surfactants for Respiratory Distress Syndrome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01852461

Enrollment

Registered

2013-05-13

Start date

2011-08-31

Completion date

2012-12-31

Last updated

2013-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Peripheral Perfusion

Keywords

natural surfactants; perfusion index

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.

Interventions

DRUGBeractant

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

DRUGPoractant 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 3 Days

Healthy volunteers

Yes

Inclusion criteria

* premature infants \< 32 weeks of gestational age

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
perfusion index	1 week	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

Measure	Time frame	Description
Duration of mechanical ventilation	4 weeks	The effects of the two treatment regimens on duration of mechanical ventilation were compared

Other

Measure	Time frame	Description
Mortality	4 weeks	The effects of the two treatment regimens on mortality were compared

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026