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Effect of human milk fortification with a human milk fortifier on growth of low birth weight infants

Effect of human milk fortification with a human milk fortifier on short term growth of preterm low birth weight infants- A randomized controlled trial at a tertiary health care centre

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032907
Enrollment
70
Registered
2021-04-19
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

None listed

Interventions

Intervention1: HUMAN MILK FORTIFIER: Study group will receive fortified human milk Fortification will be done using Lactodex HMF, 1 gram will be added to every 25 ml of milk Control Intervention1: Ex

Sponsors

DR NISHANT KUMAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm less than 37 completed weeks (based on New Ballard score) Birth weight less than 1800g and more than/equal to 1000g tolerating feeds of at least 80ml/kg/day for 3 days.

Exclusion criteria

Exclusion criteria: 1.Birth asphyxia 2.Congenital malformation. 3.Weight less than 1000g.

Design outcomes

Primary

MeasureTime frame
1. Weight gain in g/kg/day from day of initiation of intervention till four completed weeks of life (birth weight as base). 2. Head circumference increase in cm/week from day of initiation of intervention till four completed weeks of life. 3. Length increase in cm/week from day of initiation of intervention till four completed weeks of life. Timepoint: weight measurement daily during hospital stay then after 28 days of life, head circumference and length measurement weekly during hospital stay and then after 28 days of life.

Secondary

MeasureTime frame
not applicableTimepoint: not applicable

Countries

India

Contacts

Public ContactDR NIRANJANA S MAHANTASHETTI

KLE DEEMED UNIVERSITY

niranjanasn@yahoo.com9448157237

Outcome results

None listed

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