A Novel Clinical Tool For Determining Feed Intolerance In Very Small Preterms
Not Applicable
- Conditions
- Health Condition 1: P789- Perinatal digestive system disorder, unspecified
- Registration Number
- CTRI/2022/10/046259
- Lead Sponsor
- Maulana Azad Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Preterm neonates with birth weight of <1500 grams to be enrolled at least within 24hrs of initiation
of nutritional feed (beyond MEN)
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)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the sensitivity and specificity of the designed tool compared to current <br/ ><br>definition of feed intolerance (abdominal distention greater than 2 cm from baseline with <br/ ><br>gastric residual volume more than 50% of preceding feed volume OR any decision by <br/ ><br>clinician to interrupt the feeding plan of the neonate).Timepoint: Till reaching full feeds of 150 ml/kg/day
- Secondary Outcome Measures
Name Time Method 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