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The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants

NCT06729398 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2025-11-12

No results posted yet for this study

Summary

This study determines the effectiveness of cerebral Near Infrared Spectroscopy (NIRS) as a monitoring device combined with a SafeboosC treatment guideline in order to prevent brain injury in very low birth weight preterm neonates. Each experimental and control groups consists of at least 30 participants, and only the experimental group uses cerebral NIRS and a treatment guideline.

Conditions

  • Neonatal Cerebral Leukomalacia
  • Intracranial Nontraumatic Haemorrhage of Fetus and Newborn
  • Neonatal Mortality

Interventions

DEVICE

NIRS

NIRS is placed on the frontoparietal once the neonates born in the delivery room until 72 hours

OTHER

SafeboosC

SafeboosC treatment guideline is used to maintain normal value of cerebral rStO2.

Sponsors & Collaborators

  • Dr Cipto Mangunkusumo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2020-05-01
Completion
2020-05-01
FDA Device
Yes

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06729398 on ClinicalTrials.gov