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The DIAMOND trial – DIfferent Approaches to MOderate & late preterm Nutrition: Determinants of feed tolerance, body composition and development: protocol of a randomised trial

Frank H. Bloomfield Orcid Logo, Jane E. Harding, Michael P. Meyer, Jane M. Alsweiler, Yannan Jiang, Clare R. Wall, Tanith Alexander, Laura Galante Orcid Logo, (on behalf of the DIAMOND Study Group)

BMC Pediatrics, Volume: 18, Issue: 1

Swansea University Author: Laura Galante Orcid Logo

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DOI (Published version): 10.1186/s12887-018-1195-7

Abstract

BackgroundBabies born at moderate-late preterm gestations account for > 80% of all preterm births. Although survival is excellent, these babies are at increased risk of adverse neurodevelopmental outcomes. They also are at increased risk of adverse long-term health outcomes, such as cardiovascula...

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Published in: BMC Pediatrics
ISSN: 1471-2431
Published: Springer Science and Business Media LLC 2018
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URI: https://cronfa.swan.ac.uk/Record/cronfa68020
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They also are at increased risk of adverse long-term health outcomes, such as cardiovascular disease, obesity and diabetes. There is little evidence guiding optimal nutritional practices in these babies; practice, therefore, varies widely. This factorial design clinical trial will address the role of parenteral nutrition, milk supplementation and exposure of the preterm infant to taste and smell with each feed on time to tolerance of full feeds, adiposity, and neurodevelopment at 2 years.Methods/designThe DIAMOND trial is a multi-centre, factorial, randomised, controlled clinical trial. A total of 528 babies born between 32+&#x2009;0 and 35+&#x2009;6 weeks&#x2019; gestation receiving intravenous fluids and whose mothers intend to breastfeed will be randomised to one of eight treatment conditions that include a combination of each of the three interventions: (i) intravenous amino acid solution vs. intravenous dextrose solution until full milk feeds established; (ii) milk supplement vs. exclusive breastmilk, and (iii) taste/smell given or not given before gastric tube feeds. Babies will be excluded if a particular mode of nutrition is clinically indicated or there is a congenital abnormality.Primary study outcome: For parenteral nutrition and milk supplement interventions, body composition at 4 months&#x2019; corrected age. For taste/smell intervention, time to full enteral feeds defined as 150 ml.kg&#x2212;&#x2009;1.day&#x2212;&#x2009;1 or exclusive breastfeeding. Secondary outcomes: Days to full sucking feeds; days in hospital; body composition at discharge; growth to 2 years&#x2019; corrected age; development at 2 years&#x2019; corrected age; breastfeeding rates.DiscussionThis trial will provide the first direct evidence to inform feeding practices in moderate- to late-preterm infants that will optimise their growth, metabolic and developmental outcomes.</abstract><type>Journal Article</type><journal>BMC Pediatrics</journal><volume>18</volume><journalNumber>1</journalNumber><paginationStart/><paginationEnd/><publisher>Springer Science and Business Media LLC</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>1471-2431</issnElectronic><keywords>Preterm; Early nutrition; Growth; Neurodevelopmental outcome; Breastmilk; Taste and smell; Randomised factorial design</keywords><publishedDay>7</publishedDay><publishedMonth>7</publishedMonth><publishedYear>2018</publishedYear><publishedDate>2018-07-07</publishedDate><doi>10.1186/s12887-018-1195-7</doi><url/><notes/><college>COLLEGE NANME</college><department>Medical School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>MEDS</DepartmentCode><institution>Swansea University</institution><apcterm>Another institution paid the OA fee</apcterm><funders>This trial is funded by the Health Research Council of New Zealand and Counties Manukau Health.</funders><projectreference/><lastEdited>2024-12-20T13:20:46.4896680</lastEdited><Created>2024-10-18T09:02:08.0449084</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">School of Health and Social Care - Public Health</level></path><authors><author><firstname>Frank H.</firstname><surname>Bloomfield</surname><orcid>0000-0001-6424-6577</orcid><order>1</order></author><author><firstname>Jane E.</firstname><surname>Harding</surname><order>2</order></author><author><firstname>Michael P.</firstname><surname>Meyer</surname><order>3</order></author><author><firstname>Jane M.</firstname><surname>Alsweiler</surname><order>4</order></author><author><firstname>Yannan</firstname><surname>Jiang</surname><order>5</order></author><author><firstname>Clare R.</firstname><surname>Wall</surname><order>6</order></author><author><firstname>Tanith</firstname><surname>Alexander</surname><order>7</order></author><author><firstname>Laura</firstname><surname>Galante</surname><orcid>0000-0002-6190-7955</orcid><order>8</order></author><author><firstname>(on behalf of the DIAMOND Study</firstname><surname>Group)</surname><order>9</order></author></authors><documents/><OutputDurs/></rfc1807>
spelling 2024-12-20T13:20:46.4896680 v2 68020 2024-10-18 The DIAMOND trial – DIfferent Approaches to MOderate &amp; late preterm Nutrition: Determinants of feed tolerance, body composition and development: protocol of a randomised trial d1c6c22f6a863ef2050ed9768566884b 0000-0002-6190-7955 Laura Galante Laura Galante true false 2024-10-18 MEDS BackgroundBabies born at moderate-late preterm gestations account for > 80% of all preterm births. Although survival is excellent, these babies are at increased risk of adverse neurodevelopmental outcomes. They also are at increased risk of adverse long-term health outcomes, such as cardiovascular disease, obesity and diabetes. There is little evidence guiding optimal nutritional practices in these babies; practice, therefore, varies widely. This factorial design clinical trial will address the role of parenteral nutrition, milk supplementation and exposure of the preterm infant to taste and smell with each feed on time to tolerance of full feeds, adiposity, and neurodevelopment at 2 years.Methods/designThe DIAMOND trial is a multi-centre, factorial, randomised, controlled clinical trial. A total of 528 babies born between 32+ 0 and 35+ 6 weeks’ gestation receiving intravenous fluids and whose mothers intend to breastfeed will be randomised to one of eight treatment conditions that include a combination of each of the three interventions: (i) intravenous amino acid solution vs. intravenous dextrose solution until full milk feeds established; (ii) milk supplement vs. exclusive breastmilk, and (iii) taste/smell given or not given before gastric tube feeds. Babies will be excluded if a particular mode of nutrition is clinically indicated or there is a congenital abnormality.Primary study outcome: For parenteral nutrition and milk supplement interventions, body composition at 4 months’ corrected age. For taste/smell intervention, time to full enteral feeds defined as 150 ml.kg− 1.day− 1 or exclusive breastfeeding. Secondary outcomes: Days to full sucking feeds; days in hospital; body composition at discharge; growth to 2 years’ corrected age; development at 2 years’ corrected age; breastfeeding rates.DiscussionThis trial will provide the first direct evidence to inform feeding practices in moderate- to late-preterm infants that will optimise their growth, metabolic and developmental outcomes. Journal Article BMC Pediatrics 18 1 Springer Science and Business Media LLC 1471-2431 Preterm; Early nutrition; Growth; Neurodevelopmental outcome; Breastmilk; Taste and smell; Randomised factorial design 7 7 2018 2018-07-07 10.1186/s12887-018-1195-7 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Another institution paid the OA fee This trial is funded by the Health Research Council of New Zealand and Counties Manukau Health. 2024-12-20T13:20:46.4896680 2024-10-18T09:02:08.0449084 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Public Health Frank H. Bloomfield 0000-0001-6424-6577 1 Jane E. Harding 2 Michael P. Meyer 3 Jane M. Alsweiler 4 Yannan Jiang 5 Clare R. Wall 6 Tanith Alexander 7 Laura Galante 0000-0002-6190-7955 8 (on behalf of the DIAMOND Study Group) 9
title The DIAMOND trial – DIfferent Approaches to MOderate &amp; late preterm Nutrition: Determinants of feed tolerance, body composition and development: protocol of a randomised trial
spellingShingle The DIAMOND trial – DIfferent Approaches to MOderate &amp; late preterm Nutrition: Determinants of feed tolerance, body composition and development: protocol of a randomised trial
Laura Galante
title_short The DIAMOND trial – DIfferent Approaches to MOderate &amp; late preterm Nutrition: Determinants of feed tolerance, body composition and development: protocol of a randomised trial
title_full The DIAMOND trial – DIfferent Approaches to MOderate &amp; late preterm Nutrition: Determinants of feed tolerance, body composition and development: protocol of a randomised trial
title_fullStr The DIAMOND trial – DIfferent Approaches to MOderate &amp; late preterm Nutrition: Determinants of feed tolerance, body composition and development: protocol of a randomised trial
title_full_unstemmed The DIAMOND trial – DIfferent Approaches to MOderate &amp; late preterm Nutrition: Determinants of feed tolerance, body composition and development: protocol of a randomised trial
title_sort The DIAMOND trial – DIfferent Approaches to MOderate &amp; late preterm Nutrition: Determinants of feed tolerance, body composition and development: protocol of a randomised trial
author_id_str_mv d1c6c22f6a863ef2050ed9768566884b
author_id_fullname_str_mv d1c6c22f6a863ef2050ed9768566884b_***_Laura Galante
author Laura Galante
author2 Frank H. Bloomfield
Jane E. Harding
Michael P. Meyer
Jane M. Alsweiler
Yannan Jiang
Clare R. Wall
Tanith Alexander
Laura Galante
(on behalf of the DIAMOND Study Group)
format Journal article
container_title BMC Pediatrics
container_volume 18
container_issue 1
publishDate 2018
institution Swansea University
issn 1471-2431
doi_str_mv 10.1186/s12887-018-1195-7
publisher Springer Science and Business Media LLC
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care - Public Health{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care - Public Health
document_store_str 0
active_str 0
description BackgroundBabies born at moderate-late preterm gestations account for > 80% of all preterm births. Although survival is excellent, these babies are at increased risk of adverse neurodevelopmental outcomes. They also are at increased risk of adverse long-term health outcomes, such as cardiovascular disease, obesity and diabetes. There is little evidence guiding optimal nutritional practices in these babies; practice, therefore, varies widely. This factorial design clinical trial will address the role of parenteral nutrition, milk supplementation and exposure of the preterm infant to taste and smell with each feed on time to tolerance of full feeds, adiposity, and neurodevelopment at 2 years.Methods/designThe DIAMOND trial is a multi-centre, factorial, randomised, controlled clinical trial. A total of 528 babies born between 32+ 0 and 35+ 6 weeks’ gestation receiving intravenous fluids and whose mothers intend to breastfeed will be randomised to one of eight treatment conditions that include a combination of each of the three interventions: (i) intravenous amino acid solution vs. intravenous dextrose solution until full milk feeds established; (ii) milk supplement vs. exclusive breastmilk, and (iii) taste/smell given or not given before gastric tube feeds. Babies will be excluded if a particular mode of nutrition is clinically indicated or there is a congenital abnormality.Primary study outcome: For parenteral nutrition and milk supplement interventions, body composition at 4 months’ corrected age. For taste/smell intervention, time to full enteral feeds defined as 150 ml.kg− 1.day− 1 or exclusive breastfeeding. Secondary outcomes: Days to full sucking feeds; days in hospital; body composition at discharge; growth to 2 years’ corrected age; development at 2 years’ corrected age; breastfeeding rates.DiscussionThis trial will provide the first direct evidence to inform feeding practices in moderate- to late-preterm infants that will optimise their growth, metabolic and developmental outcomes.
published_date 2018-07-07T02:56:01Z
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score 11.048302

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