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Perfusion Index Variability in Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT01852461
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Dilek Dilli, Dr. Sami Ulus Children's Hospital

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

Condition or disease Intervention/treatment Phase
Poor Peripheral Perfusion Drug: Beractant Drug: Poractant alfa Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perfusion Index Variability in Preterm Infants Treated With Two Different Natural Surfactants for Respiratory Distress Syndrome
Study Start Date : August 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012


Arm Intervention/treatment
Active Comparator: Beractant
Beractant;bovine lung extract; both initial and subsequent dosing is 100 mg/kg (4 mL/kg), which may be given every 6 hours up to four total doses
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
Other Name: Beractant (Survanta)

Active Comparator: Poractant alfa
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
Drug: 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
Other Name: Poractant alfa (curosurf)




Primary Outcome Measures :
  1. perfusion index [ Time Frame: 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 Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: 4 weeks ]
    The effects of the two treatment regimens on duration of mechanical ventilation were compared


Other Outcome Measures:
  1. Mortality [ Time Frame: 4 weeks ]
    The effects of the two treatment regimens on mortality were compared



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • premature infants < 32 weeks of gestational age

Exclusion Criteria:

  • congenital malformation
  • Apgar scores <3 at 5 min

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852461


Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
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Study Director: Dilek Dilli, Assoc Prof Sami Ulus CH

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Responsible Party: Dilek Dilli, Assos Prof, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT01852461     History of Changes
Other Study ID Numbers: 685.114A
Surfactant trial ( Other Identifier: SamiUlusCH )
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013

Keywords provided by Dilek Dilli, Dr. Sami Ulus Children's Hospital:
natural surfactants; perfusion index

Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Poractant alfa
Beractant
Pulmonary Surfactants
Respiratory System Agents