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

NCT ID: NCT01923844

Last Updated: 2013-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Respiratory Distress Syndrome

Keywords

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Newborn perfusion index pulsatility index respiratory distress syndrome surfactant transcutaneous carbon monoxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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poractantalfa

preterm infants who received poractantalfa for respiratory distress syndrome

Group Type EXPERIMENTAL

exogenous surfactant

Intervention Type DRUG

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.

beractant

preterm infants who received beractant for respiratory distress syndrome

Group Type EXPERIMENTAL

exogenous surfactant

Intervention Type DRUG

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.

Control

Preterm infants without respiratory distress syndrome

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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poractantalf beractant

Eligibility Criteria

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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.
Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Yalaz

Attending Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Yalaz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ege University Faculty of Medicine, Department of Pediatrics, Division of Neonatology

Locations

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Ege University Children's Hospital Neonatal Intesive Care Unit

Izmir, İzmir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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surf_pi_co_1

Identifier Type: -

Identifier Source: org_study_id