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A Study to Evaluate the Effect of Human Milk derived Fortifiers (NeoLacta-MMF®) on the Growth of Premature Neonates of birth weight between 1000-1500g

An Open Label Study to Evaluate the Effect of Human Milk derived Fortifiers (NeoLacta-MMF®) on the Growth of Premature Neonates of birth weight between 1000-1500g.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013945
Enrollment
20
Registered
2018-05-17
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: null- Premature Neonates of birth weight between 1000-1500 gram

Interventions

Intervention1: Neolacta MMF®: 7.5 ml frozen liquid in a 15 ml bottle Control Intervention1: None: None

Sponsors

Neolacta Life Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female intramural preterm neonates below 36 weeks period of gestation requiring admission to the neonatal intensive care unit. 2. Gender - both male and female. 3. Birth weight of neonate should be between 1000-1500 g. 4. Informed consent obtained from parent or legal guardian.

Exclusion criteria

Exclusion criteria: 1. Symmetrical intrauterine growth restricted neonate 2. Preterm intrauterine growth restricted neonate with antenatal Doppler abnormalities 3. Preterm neonate with a life threatening congenital malformation or intestinal anomaly 4. Preterm neonate with dysmorphism

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of Human Milk Fortifiers on the growth of premature neonates of birth weight between 1000-1500 gTimepoint: Day1 to Day21 or hospital discharge.—

Secondary

MeasureTime frame
The secondary objective is to evaluate episodes of feed intolerance requiring interruption of feed.Timepoint: Day1 to Day21 or hospital discharge.—

Countries

India

Contacts

Public ContactDivya C

BioAgile Therapeutics Pvt. Ltd.

pm@bioagiletherapeutics.com9980107723

Outcome results

None listed

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