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Targeted Fortification of human milk in NICU

Weight gain patterns with targeted versus routine fortification of pasteurized donor human milk feeding in preterm and very low birth weight babies â?? A Randomized Controlled Trial - HMTF

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017536
Enrollment
224
Registered
2019-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: P071- Other low birth weight newborn

Interventions

Intervention1: Targeted fortification of pasteurized donor human milk using commercially available human milk fortifier: 3 g/100 ml of protein 8.8 g/100 ml of carbohydrates and 4.4 g/100 ml of fat Co

Sponsors

Dr Aarti Kinikar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Birth weight less than or equal to 1500g and gestational age less than 32weeks 2.Tolerating an enteral intake of more than or equal to 90 ml/kg/d for more than or equal to 24h 3. Family consenting to feed their baby with PDHM

Exclusion criteria

Exclusion criteria: 1. Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk 2. Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities 3.Babies with enterostoma or short gut syndrome 4. Renal disease, Hepatic dysfunctions 5. Sepsis 6. Necrotizing enterocolitis

Design outcomes

Primary

MeasureTime frame
Primary outcomes will include growth velocity ( weight, length and head circumference)Timepoint: weekly—

Secondary

MeasureTime frame
The incidence of sepsis, NEC, death, feed intolerance will be recordedTimepoint: weekly—

Countries

India

Contacts

Public ContactSmita Nimkar

B. J. Govt. Medical College and Sassoon General Hospitals, Pune

aarti.kinikar63@gmail.com9850039063

Outcome results

None listed

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