Health Condition 1: - Health Condition 2: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Sponsors
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
| Measure | Time frame |
|---|---|
| Compare the time to regain birth weight between high vs low incremental lipid administrationTimepoint: 4 weeks | — |
Secondary
| Measure | Time 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
SGPGIMS, LUCKNOW