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

NCT06729398 | Completed DMC FDA Device

• 1 other identifier: 623/UN2.F1/ETIK/2016
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Near Infrared Spectroscopy; Intraventricular hemorrhage; Periventricular leukomalacia; Preterm neonates; Very Low Birth Weight

Outcome Measures

Primary Outcomes (1)

• 72 hours preterm brain injury

  Brain ultrasonography at 72 hours of age is assessed by pediatric radiology specialist. Brain injury is positive when there are intraventricular or periventricular leukomalacia findings in the brain ultrasonography result.

  72 hours

Secondary Outcomes (1)

• Mortality rates

  28 days

Study Arms (2)

NIRS and SafeboosC group

EXPERIMENTAL

NIRS is placed on the frontoparietal once the neonates born in the delivery room until 72 hours. SafeboosC treatment guideline is used to maintain normal value of cerebral rStO2.

Device: NIRS; Other: SafeboosC

Control group

NO INTERVENTION

Standard procedure and monitoring device are used for every participant in the control group.

Interventions

NIRS DEVICE

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

NIRS and SafeboosC group

SafeboosC OTHER

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

NIRS and SafeboosC group

Eligibility Criteria

• Age: 3 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Neonates born in dr. Cipto Mangunkusumo Hospital and admitted in the neonatal intensive care unit
• Gestational age ≤ 32 weeks and/or birth weight ≤ 1500grams

You may not qualify if:

• Parents refuse to participate
• Participants who are not able to use cerebral NIRS in the first 3 hours of life
• Participants with congenital malformation and cerebral complications during delivery
• Participants who are diagnosed with IVH/PVL in the first 3 hours of life (confirmed with brain ultrasonography examination and assessed by radiology pediatric specialist)

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

Dr. Cipto Mangunkusumo General Hospital

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Leukomalacia, Periventricular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalomalacia; Vascular Diseases; Cardiovascular Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD
• Post-Marketing Study: Yes

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: May 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

ID (1)