Perfusion Index Variability in Respiratory Distress Syndrome

Poor Peripheral Perfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852461
• Other study ID #: 685.114A
• Secondary ID: Surfactant trial
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: May 10, 2013
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Dr. Sami Ulus Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

Inclusion Criteria:

• premature infants < 32 weeks of gestational age

Exclusion Criteria:

• congenital malformation

• Apgar scores <3 at 5 min

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Poor Peripheral Perfusion
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sami Ulus Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	The effects of the two treatment regimens on mortality were compared	4 weeks	No
Primary	perfusion index	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.	1 week	No
Secondary	Duration of mechanical ventilation	The effects of the two treatment regimens on duration of mechanical ventilation were compared	4 weeks	No