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Clinical Trials/CTRI/2019/03/018089
CTRI/2019/03/018089
Completed
未知

Intra operative monitoring of cerebral oxygen saturation using Near Infra Red Spectroscopy (NIRS) and Assessment of risk factors for Low cerebral oxygen saturation in preterm and very preterm infants with Retinopathy of prematurity during Vitreo retinal surgeries:An observational prospective study

HEAD OF THE DEPARTMENT0 sites50 target enrollmentTBD
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ConditionsHealth Condition 1: P09- Abnormal findings on neonatal screeningHealth Condition 2: H330- Retinal detachment with retinal break

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: P09- Abnormal findings on neonatal screeningHealth Condition 2: H330- Retinal detachment with retinal break
Sponsor
HEAD OF THE DEPARTMENT
Enrollment
50
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
December 28, 2020
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
HEAD OF THE DEPARTMENT

Eligibility Criteria

Inclusion Criteria

  • •1\.Preterm and very preterm infants with post conceptional age of 31 to 60 weeks or up to 6 months of age with Retinopathy of prematurity posted for elective Vitreo retinal surgery
  • •2\.Infants uptown 5kg weight
  • •3\.Including single and both eye Video retinal surgeries
  • •4\.Duration of surgery more than half an hour
  • •5\.Patients with mild congenital heart disease such as mild PS,mild AS,VSD can be included in this study.

Exclusion Criteria

  • •1\.Patient parental refusal for consent
  • •2\.Associated moderate\-severe congenital heart disease involving major cardio vascular shunting
  • •3\.Diagnosed with any neurological disease of brain
  • •4\.Associated structural malformations of frontal brain or scalp or skull by history or physical examination

Outcomes

Primary Outcomes

Not specified

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