Optimising Newborn Nutrition During Therapeutic Hypothermia
Research type
Research Study
Full title
Optimising newborn nutrition during therapeutic hypothermia: an observational study using routinely collected data
IRAS ID
232427
Contact name
Chris Gale
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
pending, Clinicaltrials.gov registration number
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Every year about 1200 babies in England, Wales and Scotland suffer from a lack of oxygen around birth which can lead to long-term brain injury or death. This is called Hypoxic Ischaemic Encephalopathy (HIE). We know that cooling babies with HIE by a few degrees for the first 3 days protects the brain; all UK babies with moderate or severe HIE are treated with therapeutic hypothermia (cooling).
Doctors do not know how best to care for babies while they are cooled. A key question is “how to provide nutrition to babies during cooling”. There are two main parts to this question, milk feeds (“enteral” nutrition) and intravenous nutrition (“parenteral” nutrition).
- MILK FEEDS: Some neonatal units carefully feed babies (usually with breast milk) while they are cooled. This avoids intravenous lines and may help them feed and go home earlier. Other neonatal units do not feed cooled babies because they worry about a condition called necrotising enterocolitis (a devastating and often fatal disease) which might be more common with feeding.
- INTRAVENOUS NUTRITION: All cooled babies need intravenous fluid (even when babies are fed milk they will need some intravenous fluid as well). Some neonatal units give babies intravenous nutrition (which contains fat, protein, carbohydrate, vitamins and minerals) because this may improve growth and recovery. Other neonatal units only give intravenous dextrose with simple salts because of concerns that intravenous nutrition leads to infections.This study will compare these different ways of providing nutrition. It will use a research database called the National Neonatal Research Database (NNRD), and a statistical approach called “potential outcomes framework” in which babies are matched in each group as closely as possible to ensure that any difference in outcomes is due to the different nutritional treatments, and not due to background differences or other confounders (like how sick a baby is).
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0307
Date of REC Opinion
7 Aug 2017
REC opinion
Favourable Opinion