Skip to content

A clinical study on cerebral blood oxygenation in newborn infants with altered sensorium

Prospective cohort study on the effect of Near-Infrared Spectroscopy in neonates with encephalopathy - NIRSEN

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/02/007913
Enrollment
120
Registered
2017-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Health Condition 1: null- Term neonates and preterm neonates greater than equal to 28 weeks period of gestation admitted to the neonatal intensive care unit.

Interventions

None listed

Sponsors

Vishal Vishnu Tewari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Term neonates and preterm neonates > 28 weeks admitted with any one of the following clinical conditions would be enrolled for the study. 1. hypoxic ischemic encephalopathy (HIE), 2. neonatal encephalopathy â?? all etiologies 3. neonatal seizures 4. intraventricular haemorrhage (IVH) 5. meningitis 6. preterm patent ductus arteriosus (PDA) 7. hypotension and shock 8. severe hypoxemic respiratory failure with persistent pulmonary hypertension of newborn (PPHN)

Exclusion criteria

Exclusion criteria: 1. Preterm babies below 28 weeks period of gestation 2. A baby with a congenital CNS anomaly 3. A baby with a lethal congenital anomaly or aneuploidy

Design outcomes

Primary

MeasureTime frame
Neurodevelopmental outcomes on follow-up at 3, 6, 9 and 12 months.Timepoint: 3, 6, 9 and 12 months age

Secondary

MeasureTime frame
1. To monitor the regional cerebral saturation of oxygen (rSO2) in encephalopathic neonates in the neonatal ICU. 2. To target the regional cerebral saturation of oxygen (rSO2) between the range of 55% and 85%. 3. To take corrective measure if the rSO2 goes out of the target range by employing predefined set of actions. 4. To use the measured rSO2 values for making management alterations in the ongoing therapies of enrolled neonates.Timepoint: From enrollment in the study till resolution of encephalopathy

Countries

India

Contacts

Public ContactVishal Vishnu Tewari

Armed Forces Medical Services

docvvt_13@hotmail.com8826118889

Outcome results

None listed

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