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Effects of Bolus Surfactant Therapy on Peripheral Perfusion Index and Tissue Carbon Monoxide

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
exogenous surfactant
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Respiratory Distress Syndrome focused on measuring Newborn, perfusion index, pulsatility index, respiratory distress syndrome, surfactant, transcutaneous carbon monoxide

Eligibility Criteria

undefined - 1 Day (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational age between 26 and 36 weeks
  • intubated for respiratory distress syndrome

Exclusion Criteria:

  • cardiac defects,
  • hemodynamically significant patent ductusarteriosus,
  • congenital pneumonia,
  • early sepsis
  • unstable infants in need of inotropic support.

Sites / Locations

  • Ege University Children's Hospital Neonatal Intesive Care Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

poractantalfa

beractant

Control

Arm Description

preterm infants who received poractantalfa for respiratory distress syndrome

preterm infants who received beractant for respiratory distress syndrome

Preterm infants without respiratory distress syndrome

Outcomes

Primary Outcome Measures

Change from baseline in perfusion index (PI)at 6 hours
PI values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
Change from baseline in transcutaneous carbon monoxide (TCO)at 6 hours
TCO values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.

Secondary Outcome Measures

Full Information

First Posted
August 13, 2013
Last Updated
August 15, 2013
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT01923844
Brief Title
Effects of Bolus Surfactant Therapy on Peripheral Perfusion Index and Tissue Carbon Monoxide
Official Title
Effects of Bolus Surfactant Therapy on Serial Peripheral Perfusion Index and Tissue Carbon Monoxide Measurements in Preterm Infants With Severe Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with inflammation. There are different types and doses of surfactant preparations available. With the help of new generation monitors, changes in peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.
Detailed Description
Preterm infants with severe Respiratory Distress Syndrome (study group) were compared to preterm infants without Respiratory Distress Syndrome(control group). Infants in the study group were randomized to receive either poractantalfa or beractant. Perfusion index (PI) and transcutaneous CO (TCO) values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
Newborn, perfusion index, pulsatility index, respiratory distress syndrome, surfactant, transcutaneous carbon monoxide

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
poractantalfa
Arm Type
Experimental
Arm Description
preterm infants who received poractantalfa for respiratory distress syndrome
Arm Title
beractant
Arm Type
Experimental
Arm Description
preterm infants who received beractant for respiratory distress syndrome
Arm Title
Control
Arm Type
No Intervention
Arm Description
Preterm infants without respiratory distress syndrome
Intervention Type
Drug
Intervention Name(s)
exogenous surfactant
Other Intervention Name(s)
poractantalf, beractant
Intervention Description
Preparations of poractantalfa (Curosurf, 200 mg/kg) (n = 15) or beractant (Survanta, 100 mg/kg) (n = 15) were administered in a consecutive randomized manner within the first 6 h of life. During the procedure, the tube was disconnected from the ventilator. The patient's head was held in a neutral position and surfactant preparations were given in two bolus fractions. Manual ventilation was given for 2 min after each dose. After the second dose, the endotracheal tube was reconnected and the physician (D.T.) observed the infant for 30-60 s until the oxygen saturation reached > 90% on pulse oximetry. Thereafter, the peak inspiratory pressure of the 6 ventilator was reduced by 1-2 mmH2O.
Primary Outcome Measure Information:
Title
Change from baseline in perfusion index (PI)at 6 hours
Description
PI values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
Time Frame
before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life
Title
Change from baseline in transcutaneous carbon monoxide (TCO)at 6 hours
Description
TCO values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
Time Frame
before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age between 26 and 36 weeks intubated for respiratory distress syndrome Exclusion Criteria: cardiac defects, hemodynamically significant patent ductusarteriosus, congenital pneumonia, early sepsis unstable infants in need of inotropic support.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Yalaz, M.D.
Organizational Affiliation
Ege University Faculty of Medicine, Department of Pediatrics, Division of Neonatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University Children's Hospital Neonatal Intesive Care Unit
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

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Effects of Bolus Surfactant Therapy on Peripheral Perfusion Index and Tissue Carbon Monoxide

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