Necrotizing Enterocolitis Clinical Trial
Official title:
Optimising Newborn Nutrition During Therapeutic Hypothermia: an Observational Study Using Routinely Collected Data
Verified date | November 2022 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 6030 |
Est. completion date | January 1, 2021 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Days |
Eligibility | Inclusion Criteria: 1. 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 2. Recorded gestational age at birth =36 weeks 3. Recorded as receiving therapeutic hypothermia for 72 hours or died during therapeutic hypothermia Exclusion Criteria: 1. Infants with missing data for principal background and outcome variables. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chelsea and Westminster Hospital and NHS Foundation Trust | London | |
United Kingdom | Imperial College London, Chelsea and Westminster Hospital campus | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Bliss the charity for babies born premature or sick, University of Nottingham |
United Kingdom,
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. — View Citation
Gale 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 Te — View Citation
Gale 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. — View Citation
Gale 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Survival | Survival at neonatal unit discharge | From date of birth until date of final neonatal unit discharge, assessed up to 1 year | |
Secondary | Length of Stay | Number of days between first neonatal unit admission and final neonatal unit discharge for surviving infants | From date of birth until date of final neonatal unit discharge, assessed up to 1 year | |
Secondary | Breastfeeding | Any breastfeeding (suckling at the breast) at discharge | At the point of final discharge from neonatal care, assessed up to 1 year | |
Secondary | Hypoglycaemia | Any diagnosis of hypoglycaemia recorded after therapeutic hypothermia is commenced and before the final neonatal unit discharge | From date of birth until date of final neonatal unit discharge, assessed up to 1 year | |
Secondary | Duration of Central Venous Line | The number of days until an infant is recorded as not having a central venous line | From date of birth until date of final neonatal unit discharge, assessed up to 1 year | |
Secondary | Growth | Weight for post-menstrual age standard deviation score at final neonatal unit discharge.
Standard deviation score, higher score means higher growth (higher weight for gestational age) |
From date of birth until date of final neonatal unit discharge, assessed up to 1 year |
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