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To compare the effect of fortification of Human Breast Milk via Preterm Formula Powder or Human Milk Fortifier in Preterm Very Low Birth Weight Neonates.

Fortification of Breast Milk With Preterm Formula Powder vs Human Milk Fortifier in Preterm VLBW Neonates :A Randomized clinical Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069546
Enrollment
60
Registered
2024-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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: Fortification of Expressed Breast Milk with LACTODEX Low Birth Weight FORMULA: 25ml of Expressed Breast Milk will be fortified with 1gram of Lactodex Low Birth Weight formula this int

Sponsors

Dr Geeta Gathwala
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Preterm neonates born at =32 weeks of gestation and appropriate for gestational age (AGA). 2. Birth weight less than 1500 g 3. Accepting oral feeds of at least 100ml/kg/day 4. Consuming 75% of milk or more as EBM at enrolment.

Exclusion criteria

Exclusion criteria: 1.Neonates with major congenital anomalies 2.Neonates with severe birth asphyxia.

Design outcomes

Primary

MeasureTime frame
1.Rate of in hospital weight gain in g/kg/d from the day of randomisation to the day of discharge.Timepoint: Initially at the time of admission and then daily till discharge

Secondary

MeasureTime frame
1.Weekly length gain & weekly head circumference gain 2. Feed intolerance 3.Neonatal NEC stage 2 or more 4.All cause of mortality Timepoint: Initially at the time of admission , length gain & head circumference will be measured weekly till discharge Whereas Necrotising enterocolitis along with feed intolerance & causes of mortality will be assessed daily till discharge

Countries

India

Contacts

Public ContactShikha Yadav

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences(PGIMS) Rohtak HARYANA

geetagathwala@gmail.com9896489650

Outcome results

None listed

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