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

NCT01923844 | Completed Phase 4

• 1 other identifier: surf_pi_co_1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change from baseline in perfusion index (PI)at 6 hours

  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.

  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

  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.

  before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life

Study Arms (3)

poractantalfa

EXPERIMENTAL

preterm infants who received poractantalfa for respiratory distress syndrome

Drug: exogenous surfactant

beractant

EXPERIMENTAL

preterm infants who received beractant for respiratory distress syndrome

Drug: exogenous surfactant

Control

NO INTERVENTION

Preterm infants without respiratory distress syndrome

Interventions

exogenous surfactant 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.

Also known as: poractantalf, beractant

beractant; poractantalfa

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age between 26 and 36 weeks
• intubated for respiratory distress syndrome

You may not qualify if:

• cardiac defects,
• hemodynamically significant patent ductusarteriosus,
• congenital pneumonia,
• early sepsis
• unstable infants in need of inotropic support.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Children's Hospital Neonatal Intesive Care Unit

Izmir, İzmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

beractant

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Mehmet Yalaz, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Neonatologist

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 16, 2013
• Study Start: March 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 16, 2013

Record last verified: 2013-08

Locations

TU (1)