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The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants

The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01305720
Enrollment
30
Registered
2011-03-01
Start date
2011-03-31
Completion date
2011-12-31
Last updated
2011-03-01

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

Conditions

Prematurity of Fetus

Keywords

mydriatic, NIRS, preterm, eye drops, cerebral, mesenteric oxygenation

Brief summary

Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral and mesenteric oxygenation in newborn infants. Using this technique the investigators investigated the effect of mydriatic eye drops on cerebral and mesenteric oxygenation in preterm infants

Detailed description

The cerebral and mesenteric oxygenation will be measured by NIRS before, during and after the mydriatic eye drops are instilled.

Interventions

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, the investigators applied NIRS probes to the forehead and abdomen for cerebral (rSO2C) and abdominal (rSO2P) regional oxygen saturation measurements.

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
28 Days to 90 Days
Healthy volunteers
No

Inclusion criteria

1. \< 32 gestational age and/or \< 1500gr. 2. ≥ 28th day preterm infants 3. Instilled mydriatic eye drops for ROP examination

Exclusion criteria

1. Sepsis 2. Shock 3. Severe intracranial hemorrhage 4. NEC 5. Abdominal and cranial surgery

Design outcomes

Primary

MeasureTime frameDescription
The Effect of Mydriatic Eye Drops on Cerebral and mesenteric Oxygenationone yearBy NIRS cerebral and mesenteric oxygenation will be measured before, during and after mydriatic eye drops are instilled.

Countries

Turkey (Türkiye)

Contacts

Primary ContactHatice Tatar Aksoy, MD
haticetatar@yahoo.com0905327114054
Backup ContactUgur Dilmen, Prof.
ugurdilmen@gmail.com0903123065270

Outcome results

None listed

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