Optimising Newborn Nutrition During Therapeutic Hypothermia.

Summary

The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia. To do this the investigators will perform two primary comparisons:

1. ENTERAL: to determine whether any enteral (milk) feeding, when compared to withholding enteral feeding (no milk), during therapeutic hypothermia, is associated with a difference in the incidence of necrotising enterocolitis.
2. PARENTERAL: to determine whether provision of intravenous dextrose, when compared to provision of parenteral nutrition, during therapeutic hypothermia, is associated with a difference in the incidence of blood stream infection.

The investigators will use de-identified data held in an established research database called the National Neonatal Research Database (NNRD) and we will use the potential outcomes framework with application of propensity scoring to define matched subgroups for comparison.

Conditions

• Infant, Newborn
• Asphyxia Neonatorum
• Hypothermia, Induced
• Parenteral Nutrition
• Infant Nutrition
• Necrotizing Enterocolitis
• Neonatal Sepsis

Interventions

DIETARY_SUPPLEMENT

Received enteral (milk) feeds during therapeutic hypothermia

In the enteral component of nutrition, the health technology to be assessed is the gradual introduction of enteral (milk) feeds during therapeutic hypothermia: * Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula) * This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle * This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)

DIETARY_SUPPLEMENT

Enteral (milk) feeds withheld during therapeutic hypothermia

Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.

DIETARY_SUPPLEMENT

Received parenteral nutrition during therapeutic hypothermia

In the parenteral component, the health technology being assessed is administration of parenteral nutrition during therapeutic hypothermia: * Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition) * This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter. * This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).

DIETARY_SUPPLEMENT

Did not receive parenteral nutrition during therapeutic hypothermia

Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.

Sponsors & Collaborators

• University of Nottingham

  collaborator OTHER

• Bliss Charity

  collaborator OTHER

• Imperial College London

  lead OTHER

Principal Investigators

• Chris Gale, MBBS, PhD · Imperial College London

Eligibility

Max Age

4 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-01

Primary Completion

2017-12-31

Completion

2021-01-01

Countries

• United Kingdom

Study Locations