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临床试验/CTRI/2025/11/097241
CTRI/2025/11/097241尚未招募4 期

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

Department of Neonatology1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月22日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Compare the time to regain birth weight between high vs low incremental lipid administration

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
0.00 Day(s) 至 1.00 Month(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Compare the time to regain birth weight between high vs low incremental lipid administration

时间窗: 4 weeks

次要结局

  • 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)

研究者

发起方
Department of Neonatology
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anbarasan A

SGPGIMS, LUCKNOW

研究点 (1)

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