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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Completed; Phase 4

Conditions: pOSitional Changes of Premature Infants

Treatments: Device: invos 5100; Device: Device: near infrared spectroscopy: INVOS 5100

Study type: Interventional

Funder types: Other

Identifiers

NCT01255189

3498

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 days to 2 months old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Device: near infrared spectroscopy: invos 5100

Experimental group

Description:

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

Treatment:

Device: invos 5100

Device: Device: near infrared spectroscopy: INVOS 5100