Sex-specific effects of nutritional supplements in infants born early or small: protocol for an individual participant data meta-analysis (ESSENCE IPD-MA)
Introduction Preterm and small for gestational age (SGA) infants are at increased risk of poor growth, disability and delayed development. While growing up they are also at increased risk of obesity, diabetes and later heart disease. The risk of such adverse outcomes may be altered by how preterm an...
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BMJ Publishing Group
2020-01-01
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| Online Access: | https://bmjopen.bmj.com/content/10/1/e033438.full |
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| author | Jane E Harding C Morgan Greg Gamble Caroline Crowther Luling Lin Frank Bloomfield M Agosti S A Atkinson A Biasini R D S Da Cunha N D Embleton M Faraz M S Fewtrell F Lamy Filho C Fusch M L Gianni H G Kanmaz WWK Koo I Litmanovitz A Lucas K Mukhopadhyay E Neri J Picaud E.V Rafael P Roggero A Singhal K Stroemmen M J Tan F M Tandoi CL Wood G Zachariassen |
| author_facet | Jane E Harding C Morgan Greg Gamble Caroline Crowther Luling Lin Frank Bloomfield M Agosti S A Atkinson A Biasini R D S Da Cunha N D Embleton M Faraz M S Fewtrell F Lamy Filho C Fusch M L Gianni H G Kanmaz WWK Koo I Litmanovitz A Lucas K Mukhopadhyay E Neri J Picaud E.V Rafael P Roggero A Singhal K Stroemmen M J Tan F M Tandoi CL Wood G Zachariassen |
| author_sort | Jane E Harding |
| collection | DOAJ |
| description | Introduction Preterm and small for gestational age (SGA) infants are at increased risk of poor growth, disability and delayed development. While growing up they are also at increased risk of obesity, diabetes and later heart disease. The risk of such adverse outcomes may be altered by how preterm and SGA infants are fed after birth. Faltering postnatal growth is common due to failure to achieve recommended high energy and protein intakes, and thus preterm and SGA infants are often provided with supplemental nutrition soon after birth. Enhanced nutrition has been associated with improved early growth and better cognitive development. However, limited evidence suggests that faster growth may increase the risk for later adiposity, metabolic and cardiovascular disease, and that such risks may differ between girls and boys.Methods and analysis We will search Ovid MEDLINE, Embase, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, controlled-trials.com, ClinicalTrials.gov and anzctr.org.au for randomised trials that studied the effects of macronutrient supplements for preterm and SGA infants on (i) developmental and metabolic and (ii) growth outcomes after hospital discharge. The outcomes will be (i) cognitive impairment and metabolic risk (co-primary) and (ii) body mass index. Individual participant data (IPD) from all available trials will be included using an intention-to-treat approach. A one-stage procedure for IPD meta-analysis (MA) will be used, accounting for clustering of participants within studies. Exploratory subgroup analyses will further investigate sources of heterogeneity, including sex and size of infants, different timing, duration and type of supplements.Ethics and dissemination This IPD-MA is approved by the University of Auckland Human Participants Ethics Committee (reference number: 019874). Individual studies have approval from relevant local ethics committees. Results will be disseminated in a peer-reviewed journal and presented at international conferences.PROSPERO registration number CRD42017072683 |
| format | Article |
| id | doaj-art-ae253a876ea346b98b096d69db910ad1 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-ae253a876ea346b98b096d69db910ad12025-08-20T02:19:33ZengBMJ Publishing GroupBMJ Open2044-60552020-01-0110110.1136/bmjopen-2019-033438Sex-specific effects of nutritional supplements in infants born early or small: protocol for an individual participant data meta-analysis (ESSENCE IPD-MA)Jane E Harding0C Morgan1Greg Gamble2Caroline Crowther3Luling Lin4Frank Bloomfield5M AgostiS A AtkinsonA BiasiniR D S Da CunhaN D EmbletonM FarazM S FewtrellF Lamy FilhoC FuschM L GianniH G KanmazWWK KooI LitmanovitzA LucasK MukhopadhyayE NeriJ PicaudE.V RafaelP RoggeroA Singhal6K StroemmenM J TanF M TandoiCL WoodG ZachariassenLiggins Institute, University of Auckland, Auckland, New Zealand1Academic Respiratory Unit, Bristol, UK2 Department of Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New ZealandLiggins Institute, The University of Auckland, Auckland, New ZealandLiggins Institute, The University of Auckland, Auckland, New ZealandThe University of Auckland Liggins Institute, Auckland, New Zealand1Department of Neurology, Massachusetts General Hospital, Boston, MA, USAIntroduction Preterm and small for gestational age (SGA) infants are at increased risk of poor growth, disability and delayed development. While growing up they are also at increased risk of obesity, diabetes and later heart disease. The risk of such adverse outcomes may be altered by how preterm and SGA infants are fed after birth. Faltering postnatal growth is common due to failure to achieve recommended high energy and protein intakes, and thus preterm and SGA infants are often provided with supplemental nutrition soon after birth. Enhanced nutrition has been associated with improved early growth and better cognitive development. However, limited evidence suggests that faster growth may increase the risk for later adiposity, metabolic and cardiovascular disease, and that such risks may differ between girls and boys.Methods and analysis We will search Ovid MEDLINE, Embase, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, controlled-trials.com, ClinicalTrials.gov and anzctr.org.au for randomised trials that studied the effects of macronutrient supplements for preterm and SGA infants on (i) developmental and metabolic and (ii) growth outcomes after hospital discharge. The outcomes will be (i) cognitive impairment and metabolic risk (co-primary) and (ii) body mass index. Individual participant data (IPD) from all available trials will be included using an intention-to-treat approach. A one-stage procedure for IPD meta-analysis (MA) will be used, accounting for clustering of participants within studies. Exploratory subgroup analyses will further investigate sources of heterogeneity, including sex and size of infants, different timing, duration and type of supplements.Ethics and dissemination This IPD-MA is approved by the University of Auckland Human Participants Ethics Committee (reference number: 019874). Individual studies have approval from relevant local ethics committees. Results will be disseminated in a peer-reviewed journal and presented at international conferences.PROSPERO registration number CRD42017072683https://bmjopen.bmj.com/content/10/1/e033438.full |
| spellingShingle | Jane E Harding C Morgan Greg Gamble Caroline Crowther Luling Lin Frank Bloomfield M Agosti S A Atkinson A Biasini R D S Da Cunha N D Embleton M Faraz M S Fewtrell F Lamy Filho C Fusch M L Gianni H G Kanmaz WWK Koo I Litmanovitz A Lucas K Mukhopadhyay E Neri J Picaud E.V Rafael P Roggero A Singhal K Stroemmen M J Tan F M Tandoi CL Wood G Zachariassen Sex-specific effects of nutritional supplements in infants born early or small: protocol for an individual participant data meta-analysis (ESSENCE IPD-MA) BMJ Open |
| title | Sex-specific effects of nutritional supplements in infants born early or small: protocol for an individual participant data meta-analysis (ESSENCE IPD-MA) |
| title_full | Sex-specific effects of nutritional supplements in infants born early or small: protocol for an individual participant data meta-analysis (ESSENCE IPD-MA) |
| title_fullStr | Sex-specific effects of nutritional supplements in infants born early or small: protocol for an individual participant data meta-analysis (ESSENCE IPD-MA) |
| title_full_unstemmed | Sex-specific effects of nutritional supplements in infants born early or small: protocol for an individual participant data meta-analysis (ESSENCE IPD-MA) |
| title_short | Sex-specific effects of nutritional supplements in infants born early or small: protocol for an individual participant data meta-analysis (ESSENCE IPD-MA) |
| title_sort | sex specific effects of nutritional supplements in infants born early or small protocol for an individual participant data meta analysis essence ipd ma |
| url | https://bmjopen.bmj.com/content/10/1/e033438.full |
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