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Improving Nutrition for Premature Babies Custom vs Standard Feeding Study

Evaluating the Transition from Standard to Targeted Fortification of Enteral Nutrition in Preterm Neonates (less than 32 weeks GA or less than 1.5 kg at birth ) A Two Phase Approach - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089845
Enrollment
44
Registered
2025-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Targetted fortification in preterm babies who doesnt respond to standard fortification: Babies who doesnt gain adequate weight and no adequate head and length growth, mothers milk was a

Sponsors

Dr Monica Ramasami
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Premature infants born less than 32 weeks gestational age and/or Birth Weight less than 1500 grams On human milk At 2 weeks of age , tolerating 150ml/kg/day of enteral feeds

Exclusion criteria

Exclusion criteria: Parents do no consent. Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies Grade III or IV intraventricular hemorrhage diagnoses prior to randomization Failure to initiate fortified feeds prior to 3 weeks of life Diagnosis of necrotizing entercolitis prior to randomization Diagnosis of early onset sepsis confirmed with positive culture

Design outcomes

Primary

MeasureTime frame
Weight : Percentile; z score Weight gain (g/kg/day) change in z-score from week-to-week Length : Percentile; z score Gain in length (cm/week) change in z-score from week-to-week Head Circumference: Head circumference change in cm/week, z-score value, and change in z-score from week-to-week. Head Circumference: Head circumference change in cm/week, z-score value, and change in z-score from week-to-week. Timepoint: Baseline at 1 week at 4 weeks at Discharge

Secondary

MeasureTime frame
Total Number of Days of Length of Stay in NICU Rate of Mortality Number of Feeding Intolerance Events defined as 1 or more feeds held. Number of Necrotizing Enterocolitis Events Incidence of Bronchopulmonary dysplasia Incidence of supplemental oxygen requirement at 36 weeks corrected gestational age. Incidence of Retinopathy of prematurity Timepoint: From 2 weeks of age till discharge

Countries

India

Contacts

Public ContactMonica Ramasami

Chettinad Hospital And Research Institute

giridharsethu@gmail.com9841027228

Outcome results

None listed

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