Optimising Newborn Nutrition During Therapeutic Hypothermia.
3 other identifiers
observational
6,030
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 23, 2017
CompletedFirst Posted
Study publicly available on registry
September 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedResults Posted
Study results publicly available
September 14, 2023
CompletedSeptember 14, 2023
November 1, 2022
8 years
August 23, 2017
September 20, 2021
November 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Necrotising Enterocolitis - for the Enteral Nutrition Comparison
Defined according to the case definition of Battersby et al., 2017, JAMA Pediatrics
From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Blood Stream Infection - for the Parenteral Nutrition Comparison
defined according to the Healthcare Quality Improvement Partnership (HQIP) National Neonatal Audit Programme (NNAP) case definition: pure growth of a recognised pathogen from a normally sterile site
From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Secondary Outcomes (6)
Survival
From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Length of Stay
From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Breastfeeding
At the point of final discharge from neonatal care, assessed up to 1 year
Hypoglycaemia
From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Duration of Central Venous Line
From date of birth until date of final neonatal unit discharge, assessed up to 1 year
- +1 more secondary outcomes
Study Arms (2)
Enteral nutrition comparison
This comparison refers to differences in enteral nutrition during therapeutic hypothermia
Parenteral nutrition comparison
This comparison refers to differences in parenteral nutrition during therapeutic hypothermia
Interventions
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)
Withholding enteral feeds (keeping a baby nil per os) for the duration of 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).
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
Eligibility Criteria
Infants born at 36 gestational weeks or later who received therapeutic hypothermia for Hypoxic Ischaemic Encephalopathy (HIE) for least 72 hours, or who died during therapeutic hypothermia.
You may qualify if:
- Received neonatal care at a unit that is part of the UK Neonatal Collaborative; this includes all NHS neonatal units in England, Scotland and Wales
- Recorded gestational age at birth ≥36 weeks
- Recorded as receiving therapeutic hypothermia for 72 hours or died during therapeutic hypothermia
You may not qualify if:
- \. Infants with missing data for principal background and outcome variables.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- University of Nottinghamcollaborator
- Bliss Charitycollaborator
Study Sites (2)
Chelsea and Westminster Hospital and NHS Foundation Trust
London, SW10 9NH, United Kingdom
Imperial College London, Chelsea and Westminster Hospital campus
London, SW10 9NH, United Kingdom
Related Publications (4)
Battersby C, Longford N, Patel M, Selby E, Ojha S, Dorling J, Gale C. Study protocol: optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: observational study of routinely collected data using propensity matching. BMJ Open. 2018 Oct 23;8(10):e026739. doi: 10.1136/bmjopen-2018-026739.
PMID: 30355795BACKGROUNDGale C, Jeyakumaran D, Longford N, Battersby C, Ojha S, Oughham K, Dorling J. Administration of parenteral nutrition during therapeutic hypothermia: a population level observational study using routinely collected data held in the National Neonatal Research Database. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):608-613. doi: 10.1136/archdischild-2020-321299. Epub 2021 May 5.
PMID: 33952628BACKGROUNDGale C, Longford NT, Jeyakumaran D, Ougham K, Battersby C, Ojha S, Dorling J. Feeding during neonatal therapeutic hypothermia, assessed using routinely collected National Neonatal Research Database data: a retrospective, UK population-based cohort study. Lancet Child Adolesc Health. 2021 Jun;5(6):408-416. doi: 10.1016/S2352-4642(21)00026-2. Epub 2021 Apr 21.
PMID: 33891879RESULTGale C, Jeyakumaran D, Battersby C, Ougham K, Ojha S, Culshaw L, Selby E, Dorling J, Longford N. Nutritional management in newborn babies receiving therapeutic hypothermia: two retrospective observational studies using propensity score matching. Health Technol Assess. 2021 Jun;25(36):1-106. doi: 10.3310/hta25360.
PMID: 34096500RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Chris Gale, Reader in Neonatal Medicine
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Chris Gale, MBBS, PhD
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2017
First Posted
September 12, 2017
Study Start
January 1, 2010
Primary Completion
December 31, 2017
Study Completion
January 1, 2021
Last Updated
September 14, 2023
Results First Posted
September 14, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- The NNRD holds data from 2007 to present.
- Access Criteria
- Access criteria and guidance is found at the URL below
All study data will be extracted from the National Neonatal Research Database (NNRD). The NNRD has been created through the collaborative efforts of neonatal services across the country to be a national resource. The NNRD is maintained and managed at the Neonatal Data Analysis Unit (NDAU) at Imperial College London and Chelsea and Westminster NHS Foundation Trust. Researchers, clinicians, managers, commissioners, and others are welcome and encouraged to utilise the NNRD.