| 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
|
|
|
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
|
|
|
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 |