The Effect of Surfactant Administration on Cerebral Oxygenation

NCT01258517 | Suspended

• 1 other identifier: NIRS-018
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess changes in cerebral oxygenation during two different types (beractant and poractant) and two different routes (double lumen or single lumen endotracheal tube) of surfactant administration using near infrared spectroscopy (NIRS).

Conditions

Respiratory Distress Syndrome; Prematurity

Keywords

RDS; surfactant; cerebral oxygenation; near infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• to determine the optimal and the most safe surfactant administration technique with regard to cerebral oxygenation as measured by near infrared spectroscopy in low birth weigh infants

  up to 36 weeks

Study Arms (1)

group 1, group 2, group 3, group 4

administration of beractant with single lumen ET tube administration of poractant with single lumen ET tube administration of beractant with double lumen ET tube administration of poractant with double lumen ET tube

Device: near infrared spectroscopy (INVOS 5100)

Interventions

near infrared spectroscopy (INVOS 5100) DEVICE

monitorization of cerebral oxygenation by INVOS 5100 during surfactant administration

group 1, group 2, group 3, group 4

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

\<32 week or \<1500 g required surfactant treatment for established RDS

You may qualify if:

• Clinical diagnosis of respiratory distress syndrome \<32 gestational weeks and/or \<1500 g birthweight

You may not qualify if:

• major congenital anomalies complex congenital heart diseases

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital, Neonatal Intensive Care Unit

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 13, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 5, 2016

Record last verified: 2010-11

Locations

TU (1)