Comparison of Mothers milk with formula against Mothers milk with fortifier for growth of the baby.

Motherâ??s expressed breast milk fortification with preterm formula versus human milk fortifier for very low birth weight newborns: A Randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037446

Enrollment

144

Registered

2021-10-21

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: To compare fortification of Expressed breast milk by Pre term formula powder with fortification by Human Milk Fortifier, in terms of short-term weight gain in VLBW neonates.: Baby who r

Eligibility

Inclusion criteria

Inclusion criteria: All pre-term newborns (maturity (1000 gm to 1499 gm) during the study period will be eligible for participation in the study.

Exclusion criteria

Exclusion criteria: Any newborn infant who had 1) major congenital malformation 2) necrotizing enterocolitis (NEC) stage 2 or stage 3, 3)not reaching full volume feeds by day 21 of life 4) parental lack of consent 5) Frequent feed intolerance on mothersâ?? milk during first 14 days of life.

Design outcomes

Primary

Measure	Time frame
Assessment of velocity of gain in weight.Timepoint: Total 1-year duration, 10 months for sample collection, 1 month for statistical analysis, 1 month for manuscript writing.	—

Secondary

Measure	Time frame
length, Head circumference, duration of hospital stay, comorbidities like Necrotising Enterocolitis, and feed intolerance.Timepoint: Total 1-year duration, 10 months for samples collection, 1 month for statistical analysis, 1 month for manuscript writing	—

Countries

India

Contacts

Public ContactDr Somashekhar Nimbalkar

Pramukh Swami Medical College, Karamsad

somu_somu@yahoo.com9825087842

Outcome results