Clinical Trials Directory

Trials / Completed

CompletedNCT01852461

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
Phase
N/A
Study type
Interventional
Enrollment
92 (actual)
Sponsor
Dr. Sami Ulus Children's Hospital · Academic / Other
Sex
All
Age
1 Day – 3 Days
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGBeractantBeractant;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 alfaporcine 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

Timeline

Start date
2011-08-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2013-05-13
Last updated
2013-05-13

Source: ClinicalTrials.gov record NCT01852461. Inclusion in this directory is not an endorsement.