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Role of Faster vs Slower advancement of Parenteral Lipids on Growth and Metabolic parameters in Preterm Neonates: A Randomized Controlled Trial

Effect of Low vs. High Incremental Parenteral Lipid Administration on Growth and Metabolic Outcomes in Preterm Neonates: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097241
Enrollment
60
Registered
2025-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: High increament of 1gm per kg per day of SMOF LIPIDS: To be continued at least for 5 days, and depending on the condition of newborn lipids will be continued, and baby will be followed

Sponsors

Department of Neonatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Gestational Age 33+6 weeks and weight less than 1800 grams Parenteral Nutrition (PN) Initiation Inborn neonates Started on PN from birth. Outborn neonates Started on PN within 48 hours of birth Expected PN Duration Likely to require PN for at least 5 days Clinically stable for lipid administration as per NICU protocols

Exclusion criteria

Exclusion criteria: Severe thrombocytopenia Platelet count less than 20000 per µL at enrollment Severe sepsis Shock requiring more than 2 inotropes for stabilization Inborn errors of metabolism diagnosed or strongly suspected based on clinical presentation metabolic acidosis hypoglycemia hyperammonemia Neonatal cholestasis direct bilirubin nore than 2 mg/dL before enrollment Severe hypertriglyceridemia serum triglycerides more than 400 mg per dl Preterm neonates after randomization reaching enteral feeds of 120mlper kg perday before 5 days of receiving standard lipid protocol

Design outcomes

Primary

MeasureTime frame
Compare the time to regain birth weight between high vs low incremental lipid administrationTimepoint: 4 weeks

Secondary

MeasureTime frame
Postnatal weight loss in the first week of life Early weight loss will be calculated as the maximum percentage weight loss from birth weight within the first week of life Time to achieve full enteral feeds 120 ml per kg perday Weight gain g per kg per day from regaining birth weight to discharge or term-equivalent age Weight gain g per kg per day from the day birth weight is regained until discharge or term-equivalent age using birth weight as the denominator Incidence of EUGR at discharge Lipid tolerance Hypertriglyceridemia more than 250 mg/dl LFTs Thrombocytopenia incidence at Days 3 & 7 Respiratory support needs oxygen requirement BPD incidence at 36 weeks PMA Incidence of Retinopathy of Prematurity at 36 weeks PMA. Hospital stay duration Timepoint: 4 weeks

Countries

India

Contacts

Public ContactAkansha Verma

SGPGIMS, LUCKNOW

akansha.ve@gmail.com08838443394

Outcome results

None listed

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