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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mehmet Yalaz, Ege University
ClinicalTrials.gov Identifier:
NCT01923844
First received: August 13, 2013
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome
Drug: exogenous surfactant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Ege University:

Primary Outcome Measures:
  • Change from baseline in perfusion index (PI)at 6 hours [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 48
Study Start Date: March 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: poractantalfa
preterm infants who received poractantalfa for respiratory distress syndrome
Drug: exogenous surfactant
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.
Other Names:
  • poractantalf
  • beractant
Experimental: beractant
preterm infants who received beractant for respiratory distress syndrome
Drug: exogenous surfactant
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.
Other Names:
  • poractantalf
  • beractant
No Intervention: Control
Preterm infants without respiratory distress syndrome

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.

  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01923844

Locations
Turkey
Ege University Children's Hospital Neonatal Intesive Care Unit
Izmir, Turkey, 35100
Sponsors and Collaborators
Ege University
Investigators
Principal Investigator: Mehmet Yalaz, M.D. Ege University Faculty of Medicine, Department of Pediatrics, Division of Neonatology
  More Information

No publications provided

Responsible Party: Mehmet Yalaz, Attending Neonatologist, Ege University
ClinicalTrials.gov Identifier: NCT01923844     History of Changes
Other Study ID Numbers: surf_pi_co_1
Study First Received: August 13, 2013
Last Updated: August 15, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Ege University:
Newborn
perfusion index
pulsatility index
respiratory distress syndrome
surfactant
transcutaneous carbon monoxide

Additional relevant MeSH terms:
Carbon Monoxide
Syndrome
Respiratory Distress Syndrome, Newborn
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Beractant
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014