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Identification of feed intolerance in high risk neonates using NIRS and clinical judgement in a randomised controlled trial

NIRS vs Clinical judgement based enteral feeding in high risk neonates- A Randomised Controlled Trial - NICE trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072762
Enrollment
92
Registered
2024-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: P789- Perinatal digestive system disorder, unspecified

Interventions

Intervention1: Using NIRS machine to predict feed intolerance: In this group, high risk neonates will be monitored on starting feeds for feed intolerance by using regional saturation monitored by Near

Sponsors

Kanchi Kamakoti CHILDS Trust Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates between 26 weeks to 40 weeks of gestation with expected compromised splanchnic perfusion admitted in NICU

Exclusion criteria

Exclusion criteria: Infant related: Ascites, Intraabdominal tumor, UAC in situ or No consent from parents Machine related: Severe Jaundice, Lethal Congenital anomaly, Anasarca, Hydrops, disorders of non keratinized skin

Design outcomes

Primary

MeasureTime frame
To evaluate if NIRS based (rSO2/FTOE) monitoring would predict feed intolerance episodes in high risk neonates earlier as compared to clinical assessment and monitoring during enteral feeding.Timepoint: From onset of feeds (20ml/kg) upto 100ml/kg of feed volume

Secondary

MeasureTime frame
To assess 1. Time taken to achieve full feeds in both the groups 2. Growth assessment at discharge in both the groups 3. Complications encountered in both the groups due to feed intolerance: Medical/Surgical NECTimepoint: Onset of feeds Time taken to achieve full feeds At discharge

Countries

India

Contacts

Public ContactDr Swati Iyer

Kanchi Kamakoti CHILDS Trust Hospital

dr.vaanathi@kkcth.org9962252104

Outcome results

None listed

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