Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants

Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants: A Near Infrared Spectroscopy Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01255189

Enrollment

Registered

2010-12-07

Start date

2010-12-31

Completion date

2011-06-30

Last updated

2011-08-09

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

Conditions

pOSitional Changes of Premature Infants

Keywords

NIRS

Brief summary

Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the effect of positional changes on cerebral oxygenation in preterm infants.

Detailed description

The changes in cerebral perfusion have an important role on the development of intraventricular hemorrhage and periventricular leucomalacia. Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the effect of positional changes on cerebral oxygenation in preterm infants.

Interventions

DEVICEDevice: near infrared spectroscopy: INVOS 5100

NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.

DEVICEinvos 5100

near infrared spectroscopy: invos 5100

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Days to 2 Months

Healthy volunteers

Inclusion criteria

1. \<32 gestational age and/or \<1500gr. 2. \>30th day preterm infants

Exclusion criteria

1. sepsis 2. shock 3. severe intracranial hemorrhage 4. NEC 5. abdominal and cranial surgery

Design outcomes

Primary

Measure	Time frame
The effect of positional changes on cerebral oxygenation in preterm infants	6 months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026