The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 1, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 1, 2011
February 1, 2011
3 months
February 28, 2011
February 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Effect of Mydriatic Eye Drops on Cerebral and mesenteric Oxygenation
By NIRS cerebral and mesenteric oxygenation will be measured before, during and after mydriatic eye drops are instilled.
one year
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.
Eligibility Criteria
You may qualify if:
- \< 32 gestational age and/or \< 1500gr.
- ≥ 28th day preterm infants
- Instilled mydriatic eye drops for ROP examination
You may not qualify if:
- Sepsis
- Shock
- Severe intracranial hemorrhage
- NEC
- Abdominal and cranial surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zekai Tahir Burak Maternity and Teaching Hospital
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 28, 2011
First Posted
March 1, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2011
Study Completion
December 1, 2011
Last Updated
March 1, 2011
Record last verified: 2011-02