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Study protocol: optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: observational study of routinely collected data using propensity matching

Study protocol: optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: observational study of routinely collected data using propensity matching
Study protocol: optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: observational study of routinely collected data using propensity matching

Introduction: therapeutic hypothermia is standard of care for infants born ≥36 weeks gestation with hypoxic ischaemic encephalopathy (HIE); consensus on optimum nutrition during therapeutic hypothermia is lacking. This results in variation in enteral feeding and parenteral nutrition (PN) for these infants. In this study, we aim to determine the optimum enteral nutrition and PN strategy for newborns with HIE during therapeutic hypothermia.

Methods and analysis: we will undertake a retrospective cohort study using routinely recorded electronic patient data held on the United Kingdom (UK) National Neonatal Research Database (NNRD). We will extract data from infants born ≥36 weeks gestational age between 1 January 2008 and 31 December 2016, who received therapeutic hypothermia for at least 72 hours or died during therapeutic hypothermia, in neonatal units in England, Wales and Scotland. We will form matched groups in order to perform two comparisons examining: (1) the risk of NEC between infants enterally fed and infants not enterally fed, during therapeutic hypothermia; (2) the risk of late-onset blood stream infections between infants who received intravenous dextrose without any PN and infants who received PN, during therapeutic hypothermia. The following secondary outcomes will also be examined: Survival, length of stay, breast feeding at discharge, hypoglycaemia, time to full enteral feeds and growth. Comparison groups will be matched on demographic, maternal, infant and organisational factors using propensity score matching.

Ethics and dissemination: in this study, we will use deidentifed data held in the NNRD, an established national population database; parents can opt out of their baby's data being held in the NNRD. This study holds study-specific Research Ethics Committee approval (East Midlands Leicester Central, 17/EM/0307). These results will help inform optimum nutritional management in infants with HIE receiving therapeutic hypothermia; results will be disseminated through conferences, scientific publications and parent-centred information produced in partnership with parents.

breastfeeding, hypoxic ischaemic encephalopathy, nnrd, parenteral nutrition
2044-6055
Battersby, Cheryl
24ba455f-7f54-427c-8732-3007926ee5ce
Longford, Nick
2f3303da-6aa2-49e7-bb14-df151389aee2
Patel, Mehali
c589a05c-d5b3-409e-80c1-70c1b236fdeb
Selby, Ella
4b3cbd8b-c0aa-4941-b5df-383349c18d41
Ojha, Shalini
adc62cc2-df92-446f-8ad2-4c0cf006d689
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
Gale, Chris
210b7c81-9a39-460a-9ab3-54fe92a69f8e
Battersby, Cheryl
24ba455f-7f54-427c-8732-3007926ee5ce
Longford, Nick
2f3303da-6aa2-49e7-bb14-df151389aee2
Patel, Mehali
c589a05c-d5b3-409e-80c1-70c1b236fdeb
Selby, Ella
4b3cbd8b-c0aa-4941-b5df-383349c18d41
Ojha, Shalini
adc62cc2-df92-446f-8ad2-4c0cf006d689
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
Gale, Chris
210b7c81-9a39-460a-9ab3-54fe92a69f8e

Battersby, Cheryl, Longford, Nick, Patel, Mehali, Selby, Ella, Ojha, Shalini, Dorling, Jon and Gale, Chris (2018) 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, 8 (10), [e026739]. (doi:10.1136/bmjopen-2018-026739).

Record type: Article

Abstract

Introduction: therapeutic hypothermia is standard of care for infants born ≥36 weeks gestation with hypoxic ischaemic encephalopathy (HIE); consensus on optimum nutrition during therapeutic hypothermia is lacking. This results in variation in enteral feeding and parenteral nutrition (PN) for these infants. In this study, we aim to determine the optimum enteral nutrition and PN strategy for newborns with HIE during therapeutic hypothermia.

Methods and analysis: we will undertake a retrospective cohort study using routinely recorded electronic patient data held on the United Kingdom (UK) National Neonatal Research Database (NNRD). We will extract data from infants born ≥36 weeks gestational age between 1 January 2008 and 31 December 2016, who received therapeutic hypothermia for at least 72 hours or died during therapeutic hypothermia, in neonatal units in England, Wales and Scotland. We will form matched groups in order to perform two comparisons examining: (1) the risk of NEC between infants enterally fed and infants not enterally fed, during therapeutic hypothermia; (2) the risk of late-onset blood stream infections between infants who received intravenous dextrose without any PN and infants who received PN, during therapeutic hypothermia. The following secondary outcomes will also be examined: Survival, length of stay, breast feeding at discharge, hypoglycaemia, time to full enteral feeds and growth. Comparison groups will be matched on demographic, maternal, infant and organisational factors using propensity score matching.

Ethics and dissemination: in this study, we will use deidentifed data held in the NNRD, an established national population database; parents can opt out of their baby's data being held in the NNRD. This study holds study-specific Research Ethics Committee approval (East Midlands Leicester Central, 17/EM/0307). These results will help inform optimum nutritional management in infants with HIE receiving therapeutic hypothermia; results will be disseminated through conferences, scientific publications and parent-centred information produced in partnership with parents.

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More information

Accepted/In Press date: 22 September 2018
e-pub ahead of print date: 23 October 2018
Additional Information: Funding Information: the study is funded through NIHR HTA grant 16/79/03. CG is supported by the United Kingdom Medical Research Council (MRC) through a Clinician Scientist Fellowship.
Keywords: breastfeeding, hypoxic ischaemic encephalopathy, nnrd, parenteral nutrition

Identifiers

Local EPrints ID: 485078
URI: http://eprints.soton.ac.uk/id/eprint/485078
ISSN: 2044-6055
PURE UUID: bd56f5f9-b83d-4a3c-917d-52bb8473c4ab
ORCID for Jon Dorling: ORCID iD orcid.org/0000-0002-1691-3221

Catalogue record

Date deposited: 29 Nov 2023 17:31
Last modified: 06 Jun 2024 02:20

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Contributors

Author: Cheryl Battersby
Author: Nick Longford
Author: Mehali Patel
Author: Ella Selby
Author: Shalini Ojha
Author: Jon Dorling ORCID iD
Author: Chris Gale

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