The Effect of Surfactant Administration on Cerebral Oxygenation

The Effect of the Type and the Method of Surfactant Administration on Oxygenation in Preterm Infants: a Near Infrared Spectroscopy Study

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01258517

Enrollment

Registered

2010-12-13

Start date

2010-11-30

Completion date

2018-12-31

Last updated

2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity, Respiratory Distress Syndrome

Keywords

RDS, surfactant, cerebral oxygenation, near infrared spectroscopy

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).

Interventions

DEVICEnear infrared spectroscopy (INVOS 5100)

monitorization of cerebral oxygenation by INVOS 5100 during surfactant administration

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

23 Weeks to 32 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026