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

NCT01923844 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-08-16

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome

Interventions

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.

Sponsors & Collaborators

  • Ege University

    lead OTHER

Principal Investigators

  • Mehmet Yalaz, M.D. · Ege University Faculty of Medicine, Department of Pediatrics, Division of Neonatology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01923844 on ClinicalTrials.gov