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Monitoring of Cerebral oxygen saturation in preterm and very preterm infants diagnosed with Retinopathy of prematurity during Vitreo retinal surgeries using Near Infra Red Spectroscopy and Assessment of risk factors for Low cerebral oxygen saturation: An observational prospective study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/03/018089
Enrollment
50
Registered
2019-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: P09- Abnormal findings on neonatal screening Health Condition 2: H330- Retinal detachment with retinal break

Interventions

None listed

Sponsors

HEAD OF THE DEPARTMENT
Lead Sponsor

Eligibility

Inclusion 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. 4.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
To find out the incidence of low cerebral oxygen saturation (mild-severe) in preterm and very preterm infants with Retinopathy of prematurity undergoing Vitreo retinal surgeryTimepoint: 1.Mild-relative decrease in rScO2 of 11-20% from baseline value or absolute rScO2 60-69% for more than 3 minute 2.Moderate -decrease of 21-30% from baseline value or absolute value 50-55% for more than 3 minutes 3.Severe-relative decrease in rScO2 greater than 30% below baseline or absolute value less than 50% for more than 3 minutes

Secondary

MeasureTime frame
To describe differences in regional cerebral oxygen saturation (rScO2) during different timelines of anaesthesia such as induction,during surgery and extubationTimepoint: 1.Baseline-time between placement of NIRS probe on patients forehead before induction of anesthesia and administration of anaesthetic drugs or supplemental oxygen to induce anesthesia 2.Induction time-time from administration of anesthetic induction drugs to the start of surgery 3.Surgery time-time from start of incision until the last stitch or dressing to be placed 4.Emergence time-time from 3-5minutes after the last stitch or dressing being placed till extubation of child;To identify factors associated with Low cerebral oxygen saturation in preterm and very preterm infants with Retinopathy of prematurity undergoing Vitreo retinal surgeryTimepoint: 1.Preterm-babies born alive before 37 weeks of gestational age Late preterm-32 to 37weeks Very preterm-28-32weeks Extremely pretty-less than 28weeks 2.Staging of Rop according to international classification 3.Hypotension lasting for 3 minutes Mild-MAP of 36-45mmHg or systolic Bp 51-60mmHg Moderate-MAP of 26-35mmHg or systolic Bp 41-50mmHg Severe-MAP of less than 25mmHg or systolic Bp less than 40mmHg

Countries

India

Contacts

Public ContactDILIP R SHENDE

All India Institute Of Medical Sciences New Delhi

dilipshende@gmail.com8800377697

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026