The Effect of Surfactant Administration on Cerebral Oxygenation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT01258517
First received: December 7, 2010
Last updated: December 10, 2010
Last verified: November 2010
  Purpose

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).


Condition Intervention
Respiratory Distress Syndrome
Prematurity
Device: near infrared spectroscopy (INVOS 5100)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of the Type and the Method of Surfactant Administration on Oxygenation in Preterm Infants: a Near Infrared Spectroscopy Study

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • 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 [ Time Frame: up to 36 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
monitorization of cerebral oxygenation by INVOS 5100 during surfactant administration

  Eligibility

Ages Eligible for Study:   23 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

major congenital anomalies complex congenital heart diseases

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258517

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital, Neonatal Intensive Care Unit Recruiting
Ankara, Turkey, 06100
Contact: Gozde Kanmaz, MD    90 505 588 11 89    gzdekanmaz@yahoo.com   
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

No publications provided

Responsible Party: Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01258517     History of Changes
Other Study ID Numbers: NIRS-018
Study First Received: December 7, 2010
Last Updated: December 10, 2010
Health Authority: Turkey: Ethics Committee

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
RDS
surfactant
cerebral oxygenation
near infrared specroscopy

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Pulmonary Surfactants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014