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Helping low birth weight preterm babies grow: comparing two nutrient mixes added to mother s milk

Human Milk Fortifier Vs Preterm formula milk for fortification of Preterm Human Milk. A Non Inferiority Randomized Controlled Trial (PREMFORT STUDY) - PREMFORT (PREMature infant FORTification trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/089932
Enrollment
164
Registered
2025-07-01
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: Preterm Formula Powder: To add 1gm in 25ml Preterm Human Milk Control Intervention1: Commercial Human Milk Fortifier : To add 1 sachet (1gm) in 25ml Preterm Human Milk

Sponsors

DR Ammar Haider
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates with gestational age less than 34 weeks, Birth weight less than 1500 grams (Very Low Birth Weight), Receiving at least 100 mL/kg/day of expressed breast milk at the time of enrollment, Written informed consent obtained from parent or legal guardian.

Exclusion criteria

Exclusion criteria: Presence of major congenital anomalies, Neonates requiring surgery during NICU stay, Infants not receiving mother s own milk or receiving less than 75% of feeds as expressed breast milk Neonates on mechanical ventilation at the time of enrollment

Design outcomes

Primary

MeasureTime frame
Mean weight gain (g/kg/day)Timepoint: At 40 weeks postmenstrual age or discharge

Secondary

MeasureTime frame
Length gain (cm/week)Timepoint: Weekly until discharge;Head circumference gain (cm/week)Timepoint: Weekly until discharge;Feed intoleranceTimepoint: During hospital stay;Late onset sepsisTimepoint: After 72 hours of life;Anemia requiring transfusionTimepoint: During hospital stay;Hemodynamically significant PDATimepoint: During hospital stay;ROP requiring laser therapyTimepoint: During hospital stay;Moderate to severe BPDTimepoint: At 36 weeks postmenstrual age;IVH more than grade 2Timepoint: During hospital stay

Countries

India

Contacts

Public ContactDr Amol Joshi

GMCH, Chhatrapati sambhajinagar

dramolkj@gmail.com9823900641

Outcome results

None listed

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