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CTRI Number  CTRI/2025/11/097241 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Faster vs Slower advancement of Parenteral Lipids on Growth and Metabolic parameters in Preterm Neonates: A Randomized Controlled Trial 
Scientific Title of Study   Effect of Low vs. High Incremental Parenteral Lipid Administration on Growth and Metabolic Outcomes in Preterm Neonates: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anbarasan A 
Designation  DM Neonatology Resident 
Affiliation  SGPGIMS, LUCKNOW 
Address  Room NO 820, M2 Doctors Hostel, SGPGIMS, LUCKNOW

Lucknow
UTTAR PRADESH
226014
India 
Phone  08838443394  
Fax    
Email  anburani07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Akansha Verma 
Designation  Associate Professor 
Affiliation  SGPGIMS, LUCKNOW 
Address  Department of Neonatology, SGPGIMS, LUCKNOW

Lucknow
UTTAR PRADESH
226014
India 
Phone  08838443394  
Fax    
Email  akansha.ve@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Akansha Verma 
Designation  Associate Professor 
Affiliation  SGPGIMS, LUCKNOW 
Address  Department of Neonatology, SGPGIMS, LUCKNOW

Lucknow
UTTAR PRADESH
226014
India 
Phone  08838443394  
Fax    
Email  akansha.ve@gmail.com  
 
Source of Monetary or Material Support  
Department of Neonatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh - 226014  
 
Primary Sponsor  
Name  Department of Neonatology 
Address  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh - 226014  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anbarasan A  Sanjay Gandhi Postgraduate Institute of Medical Sciences  Department of Neonatology PMSSY Block First Floor
Lucknow
UTTAR PRADESH 
08838443394

anburani09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGPGIMS, RAEBARELI , LUCKNOW  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 up untill 28days of life with recommended parameters 
Comparator Agent  Low increment of 0.5gm 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 up untill 28days of life with recommended parameters 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Month(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Compare the time to regain birth weight between high vs low incremental lipid administration  4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
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
 
4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   22/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Parenteral nutrition PN plays a critical role in managing preterm neonates who cannot achieve adequate enteral intake Among its components intravenous lipid emulsions ILEs serve as a vital energy source and provide essential fatty acids necessary for optimal growth metabolic function and neurodevelopment Despite decades of research and advancements in lipid formulations the optimal lipid administration strategy in preterm neonates remains debated particularly regarding the rate of lipid advancement and its impact on metabolic and clinical outcomes 

Current neonatal nutrition practices advocate for early and aggressive PN to reduce postnatal growth failure and enhance long term neurodevelopmental outcomes However concerns persist regarding early high dose lipid administration particularly its potential association with metabolic complications such as hypertriglyceridemia thrombocytopenia hepatic dysfunction and respiratory morbidities The introduction of composite lipid emulsions such as SMOF lipid a blend of soybean oil medium chain triglycerides olive oil and fish oil aims to mitigate some of these risks by providing a balanced lipid profile with anti inflammatory omega 3 fatty acids

The rate of lipid increment in preterm neonates is a critical factor influencing neonatal growth and metabolic adaptation Traditional protocols employ a conservative increment of 05 gkgday whereas more recent studies suggest that a higher increment 1 g per kg per day may support improved weight gain and better metabolic outcomes without increasing the risk of complications However evidence remains inconclusive and there is a pressing need for well controlled trials to determine the safest and most effective lipid advancement strategy in this vulnerable population

This randomized controlled trial RCT aims to evaluate the effect of low 0point 5 g per kg per day vs high 1 g per kg per day incremental lipid administration on growth and metabolic outcomes in preterm neonates receiving SMOF lipid based parenteral nutrition We hypothesize that a higher lipid increment may lead to improved weight gain reduced extrauterine growth restriction EUGR better lipid tolerance and minimal metabolic derangements By systematically assessing anthropometric changes biochemical markers thrombocytopenia incidence respiratory outcomes and hospital stay duration this study will contribute valuable evidence to guide lipid administration practices in neonatal intensive care settings

 
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