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A Novel Clinical Tool For Determining Feed Intolerance In Very Small Preterms

Validation Of A Novel Clinical Tool For Determining Feed Intolerance In Preterm Very Low Birth Weight Neonates

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/10/046259
Enrollment
150
Registered
2022-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Maulana Azad Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates with birth weight of of nutritional feed (beyond MEN)

Exclusion criteria

Exclusion criteria: 1. Necrotizing enterocolitis (Bellâ??s stage II or worse) before initiation of feeds 2. Cardiorespiratory compromise evidenced by need of more than one inotrope or single inotrope with dose more than 15 microgram/kg/min infusion. 3. Infants with Gross Congenital Anomalies 4. Infants with Perinatal asphyxia (APGAR less than 5 at 5 minutes)

Design outcomes

Secondary

MeasureTime frame
â?¢ To determine the incidence of FI among preterm VLBW neonatesTimepoint: Till reaching full feeds of 150 ml/kg/day;To assess the acceptance among the nursing staff through a 5-point Likert scaleTimepoint: at the end of the study period;To assess the maternal and neonatal factors associated with feed intoleranceTimepoint: Till reaching full feeds of 150 ml/kg/day;To describe the various clinical features associated with feed intolerance in preterm babiesTimepoint: Till reaching full feeds of 150 ml/kg/day;To establish the correlation of individual components of the tool with Feed IntoleranceTimepoint: Till reaching full feeds of 150 ml/kg/day

Primary

MeasureTime frame
To determine the sensitivity and specificity of the designed tool compared to current definition of feed intolerance (abdominal distention greater than 2 cm from baseline with gastric residual volume more than 50% of preceding feed volume OR any decision by clinician to interrupt the feeding plan of the neonate).Timepoint: Till reaching full feeds of 150 ml/kg/day

Countries

India

Contacts

Public ContactShoham Majumder

Maulana Azad Medical College

neoashish2008@gmail.com9810694789

Outcome results

None listed

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