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Completed

NCT Number: NCT01852461

Perfusion Index Variability in Respiratory Distress Syndrome

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

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Key information

Conditions

Poor Peripheral Perfusion

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • premature infants < 32 weeks of gestational age

Exclusion criteria

  • congenital malformation
  • Apgar scores <3 at 5 min

Treatment and study plan

Beractant

Drug

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 names: Beractant (Survanta)

Poractant alfa

Drug

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 names: Poractant alfa (curosurf)

Primary outcomes

  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 outcomes

  1. Duration of mechanical ventilation

    Time frame: 4 weeks

    The effects of the two treatment regimens on duration of mechanical ventilation were compared

Other outcomes

  1. Mortality

    Time frame: 4 weeks

    The effects of the two treatment regimens on mortality were compared

Sponsors and collaborators

Lead sponsor

Dr. Sami Ulus Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 13, 2013
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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