Comparative study of the infection rate with standard Vs newer intravenous fat solutions in very premature babies

Effect of soybean oil Versus (Olive oil + fish oil) based parenteral lipid emulsion on the incidence of late onset sepsis in very preterm neonates - A Randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/10/010005

Enrollment

260

Registered

2017-10-04

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- Preterm infants needing total parenteral nutrition

Interventions

Intervention1: SMOF lipid infusion: Intravenous lipid infusion containing- (soybean oil+ medium chain triglycerides +Olive oil +fish oil) starting with a dose of 1g/kg/day administered over 20 hours a

Eligibility

Inclusion criteria

Inclusion criteria: Inborn/outborn neonates <30 weeks gestational age and/or birth weight <1200gms admitted to the NICU within 10 days of postnatal age and on < 20ml/kg/day of enteral feeds.

Exclusion criteria

Exclusion criteria: congenital malformation incompatible with life.

Design outcomes

Primary

Measure	Time frame
Incidence of late onset sepsisTimepoint: from 72 hours of postnatal age until discharge	—

Secondary

Measure	Time frame
Mortality at 28 days and before discharge, Weight,length and head circumference gain during NICU stay,time to full enteral feeds, time to regain birth weight, duration of respiratory support,oxygen therapy and hospital stay,incidence of ROP,NEC,BPD, IVH and PVL,incidence of thrombocytopenia, hypertriglyceridemia Timepoint: from 72 hours of postnatal age until discharge	—

Countries

India

Contacts

Public ContactDr Haribalakrishna Balasubramanian

Surya Childrens hospital

doctorhbk@gmail.com

Outcome results

None listed

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