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A CLINICAL STUDY IN PRETERM NEONATES TO ASSES THE EFFECT OF BLOOD TRANSFUSION ON OXYGEN CONCENTRATION IN BRAIN AND GUT CIRCULATION

EFFECT OF RED BLOOD CELL TRANSFUSION ON CEREBRAL AND SPLANCHNIC REGIONAL OXYGEN SATURATION IN PRETERM NEONATES: A PROSPECTIVE OBSERVATIONAL STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/12/022463
Enrollment
15
Registered
2019-12-20
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: D539- Nutritional anemia, unspecified

Interventions

None listed

Sponsors

Deptt of Neonatology Sir ganga Ram Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates requiring RBC transfusion during their NICU stay as per Canadian Pediatric Society (CPS) guidelines

Exclusion criteria

Exclusion criteria: Following neonates will be excluded from study: i. Neonates requiring invasive mechanical Ventilation and/or inotropic support. ii. Intraventricular hemorrhage Grade II or more. iii. Diagnosis of NEC at the time of transfusion. iv. Major congenital anomalies v. Parental refusal to participation in study

Design outcomes

Primary

MeasureTime frame
i. To compare the regional cerebral regional oxygen saturation (crSO2) and splanchnic regional oxygen saturation (srSO2) using Near Infrared Spectroscopy (NIRS) before and after RBC transfusion in preterm neonates.Timepoint: i. To compare the regional cerebral regional oxygen saturation (crSO2) and splanchnic regional oxygen saturation (srSO2) using Near Infrared Spectroscopy (NIRS) before and after RBC transfusion in preterm neonates.—

Secondary

MeasureTime frame
i. Cerebral fractional tissue oxygen extraction (cFTOE) and splanchnic fractional tissue oxygen extraction (sFTOE) levels. ii. Heart rate, mean arterial blood pressure and proportion of time spent with saturation below 80%. Timepoint: i. Cerebral fractional tissue oxygen extraction (cFTOE) and splanchnic fractional tissue oxygen extraction (sFTOE) levels. ii. Heart rate, mean arterial blood pressure and proportion of time spent with saturation below 80%.—

Countries

India

Contacts

Public ContactMANISHA MEHTA

Department of Neonatology Institute of Child Health Sir Ganga Ram Hospital-New Delhi

satishsaluja@gmail.com

Outcome results

None listed

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