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The Effect of Surfactant Administration on Cerebral Oxygenation

This study has suspended participant recruitment.
(principle investigator moved to an another hospital)
Sponsor:
Information provided by (Responsible Party):
Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT01258517
First received: December 7, 2010
Last updated: September 1, 2016
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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts 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   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
<32 week or <1500 g required surfactant treatment for established RDS
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
Ankara, Turkey, 06100
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

Responsible Party: Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT01258517     History of Changes
Other Study ID Numbers: NIRS-018 
Study First Received: December 7, 2010
Last Updated: September 1, 2016
Health Authority: Turkey: Ethics Committee

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

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

ClinicalTrials.gov processed this record on December 09, 2016