Skip to content

Comparison of two fat solutions( SMOFLipid® and Intralipid®) for intravenous injection in premature newborns(less than or equal to 34 weeks gestation) and their effects on time taken by babies to regain their birth weight: A randomised controlled trial

Effect of SMOFLipid® vs. Intralipid® on Time to Regain Birth Weight in Preterm Neonates (�34 weeks): A Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031136
Enrollment
80
Registered
2021-02-09
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: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: SMOFLipid®: SMOFLipid is a intravenous lipid emulsion to be given in standard doses 1-3.5 g/kg/day via iv route and daily 24 hours infusion Duration as per standard unit protocol ( us

Sponsors

Institue Research Grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Preterm neonates 2.Initiated on parenteral nutrition including lipids (at least 1 g/kg/day) in first three days of life 3.Anticipated to receive parenteral nutrition for at least 5 days â?? e.g. neonates

Exclusion criteria

Exclusion criteria: Neonates with major congenital malformation and hydrops will be excluded from the study

Design outcomes

Primary

MeasureTime frame
Time to regain birth weight in daysTimepoint: daily weight will be taken till birth weight is regained

Secondary

MeasureTime frame
Catalase, Superoxide Dismutase and Glutathione PeroxidaseTimepoint: Day 0 and day 7;Fatty acid profile by HPLCTimepoint: Day 0 and day 7;Hypertriglyceridemia more than 265 mg/dlTimepoint: Day 0 and day 7;Parenteral Nutrition Associated Liver Disease defined as direct bilirubin more than 2 mg/dlTimepoint: 2 weeks;Retinopathy of PrematurityTimepoint: 4 weeks as per unit protocol;Weekly head growth in first 4 weeksTimepoint: Weekly for first 4 weeks;Weekly weight gain in first 4 weeksTimepoint: Weekly for first 4 weeks

Countries

India

Contacts

Public ContactMd Tousifullah

All India Institute of Medical Sciences, New Delhi

dranuthukral@gmail.com011-26596167

Outcome results

None listed

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