Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): Study protocol

Anna Lene Seidler; Lelia Duley; Anup C. Katheria; Catalina De Paco Matallana; Eugene Dempsey; Heike Rabe; John Kattwinkel; Judith Mercer; Justin Josephsen; Karen Fairchild; Ola Andersson; Shigeharu Hosono; Venkataseshan Sundaram; Vikram Datta; Walid El-Naggar; William Tarnow-Mordi; Thomas Debray; Stuart B. Hooper; Martin Kluckow; Graeme Polglase; Peter G. Davis; Alan Montgomery; Kylie E. Hunter; Angie Barba; John Simes; Lisa Askie

doi:10.1136/bmjopen-2019-034595

Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): Study protocol

Anna Lene Seidler, Lelia Duley, Anup C. Katheria, Catalina De Paco Matallana, Eugene Dempsey, Heike Rabe, John Kattwinkel, Judith Mercer, Justin Josephsen, Karen Fairchild, Ola Andersson, Shigeharu Hosono, Venkataseshan Sundaram, Vikram Datta, Walid El-Naggar, William Tarnow-Mordi, Thomas Debray, Stuart B. Hooper, Martin Kluckow, Graeme PolglasePeter G. Davis, Alan Montgomery, Kylie E. Hunter, Angie Barba, John Simes, Lisa Askie

Medicine

Résultat de recherche: Article › examen par les pairs

19 Citations (Scopus)

Résumé

Introduction Timing of cord clamping and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups. Previous and current trials compare various policies, including time-based or physiology-based deferred cord clamping, and cord milking. Individual participant data (IPD) enable exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons. Objectives (1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis. (2) To evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA. Methods and analysis Systematic searches of Medline, Embase, clinical trial registries, and other sources for all ongoing and completed randomised controlled trials comparing cord management strategies at preterm birth (before 37 weeks' gestation) have been completed up to 13 February 2019, but will be updated regularly to include additional trials. IPD will be sought for all trials; aggregate summary data will be included where IPD are unavailable. First, deferred clamping and cord milking will be compared with immediate clamping in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for prespecified participant subgroups. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes. Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored. Ethics and dissemination Ethics approval for this project has been granted by the University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline developers and policy-makers, and will be disseminated via publications, presentations and media releases. Registration number Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001305112) and International Prospective Register of Systematic Reviews (PROSPERO, CRD42019136640).

Langue d'origine	English
Numéro d'article	e034595
Journal	BMJ Open
Volume	10
Numéro de publication	3
DOI	https://doi.org/10.1136/bmjopen-2019-034595
Statut de publication	Published - mars 29 2020

Note bibliographique

Funding Information:
Funding Support for developing the protocol and establishing the collaborative group was received from the UK National Institute of Health Research with a grant entitled “The Preterm Birth Programme” (number RPPG060910107). This grant presents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG0609-10107). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Funding for individual trials remains the responsibility of the trialists themselves. Funding to undertake data collection and data analysis for the iCOMP Collaboration has been provided by the Australian National Health and Medical Research Council via a Project Grant (APP1163585).

Publisher Copyright:
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

ASJC Scopus Subject Areas

General Medicine

ODD de l’ONU

Cette action contribue à la réalisation des objectifs de développement durable suivants

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10.1136/bmjopen-2019-034595

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Seidler, A. L., Duley, L., Katheria, A. C., De Paco Matallana, C., Dempsey, E., Rabe, H., Kattwinkel, J., Mercer, J., Josephsen, J., Fairchild, K., Andersson, O., Hosono, S., Sundaram, V., Datta, V., El-Naggar, W., Tarnow-Mordi, W., Debray, T., Hooper, S. B., Kluckow, M., ... Askie, L. (2020). Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): Study protocol. BMJ Open, 10(3), Article e034595. https://doi.org/10.1136/bmjopen-2019-034595

Seidler, AL, Duley, L, Katheria, AC, De Paco Matallana, C, Dempsey, E, Rabe, H, Kattwinkel, J, Mercer, J, Josephsen, J, Fairchild, K, Andersson, O, Hosono, S, Sundaram, V, Datta, V, El-Naggar, W, Tarnow-Mordi, W, Debray, T, Hooper, SB, Kluckow, M, Polglase, G, Davis, PG, Montgomery, A, Hunter, KE, Barba, A, Simes, J & Askie, L 2020, 'Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): Study protocol', BMJ Open, vol. 10, n° 3, e034595. https://doi.org/10.1136/bmjopen-2019-034595

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title = "Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): Study protocol",

abstract = "Introduction Timing of cord clamping and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups. Previous and current trials compare various policies, including time-based or physiology-based deferred cord clamping, and cord milking. Individual participant data (IPD) enable exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons. Objectives (1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis. (2) To evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA. Methods and analysis Systematic searches of Medline, Embase, clinical trial registries, and other sources for all ongoing and completed randomised controlled trials comparing cord management strategies at preterm birth (before 37 weeks' gestation) have been completed up to 13 February 2019, but will be updated regularly to include additional trials. IPD will be sought for all trials; aggregate summary data will be included where IPD are unavailable. First, deferred clamping and cord milking will be compared with immediate clamping in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for prespecified participant subgroups. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes. Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored. Ethics and dissemination Ethics approval for this project has been granted by the University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline developers and policy-makers, and will be disseminated via publications, presentations and media releases. Registration number Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001305112) and International Prospective Register of Systematic Reviews (PROSPERO, CRD42019136640).",

author = "Seidler, {Anna Lene} and Lelia Duley and Katheria, {Anup C.} and {De Paco Matallana}, Catalina and Eugene Dempsey and Heike Rabe and John Kattwinkel and Judith Mercer and Justin Josephsen and Karen Fairchild and Ola Andersson and Shigeharu Hosono and Venkataseshan Sundaram and Vikram Datta and Walid El-Naggar and William Tarnow-Mordi and Thomas Debray and Hooper, {Stuart B.} and Martin Kluckow and Graeme Polglase and Davis, {Peter G.} and Alan Montgomery and Hunter, {Kylie E.} and Angie Barba and John Simes and Lisa Askie",

note = "Funding Information: Funding Support for developing the protocol and establishing the collaborative group was received from the UK National Institute of Health Research with a grant entitled “The Preterm Birth Programme” (number RPPG060910107). This grant presents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG0609-10107). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Funding for individual trials remains the responsibility of the trialists themselves. Funding to undertake data collection and data analysis for the iCOMP Collaboration has been provided by the Australian National Health and Medical Research Council via a Project Grant (APP1163585). Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.",

year = "2020",

month = mar,

day = "29",

doi = "10.1136/bmjopen-2019-034595",

language = "English",

volume = "10",

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T1 - Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP)

T2 - Study protocol

AU - Seidler, Anna Lene

AU - Duley, Lelia

AU - Katheria, Anup C.

AU - De Paco Matallana, Catalina

AU - Dempsey, Eugene

AU - Rabe, Heike

AU - Kattwinkel, John

AU - Mercer, Judith

AU - Josephsen, Justin

AU - Fairchild, Karen

AU - Andersson, Ola

AU - Hosono, Shigeharu

AU - Sundaram, Venkataseshan

AU - Datta, Vikram

AU - El-Naggar, Walid

AU - Tarnow-Mordi, William

AU - Debray, Thomas

AU - Hooper, Stuart B.

AU - Kluckow, Martin

AU - Polglase, Graeme

AU - Davis, Peter G.

AU - Montgomery, Alan

AU - Hunter, Kylie E.

AU - Barba, Angie

AU - Simes, John

AU - Askie, Lisa

N1 - Funding Information: Funding Support for developing the protocol and establishing the collaborative group was received from the UK National Institute of Health Research with a grant entitled “The Preterm Birth Programme” (number RPPG060910107). This grant presents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG0609-10107). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Funding for individual trials remains the responsibility of the trialists themselves. Funding to undertake data collection and data analysis for the iCOMP Collaboration has been provided by the Australian National Health and Medical Research Council via a Project Grant (APP1163585). Publisher Copyright: © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

PY - 2020/3/29

Y1 - 2020/3/29

N2 - Introduction Timing of cord clamping and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups. Previous and current trials compare various policies, including time-based or physiology-based deferred cord clamping, and cord milking. Individual participant data (IPD) enable exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons. Objectives (1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis. (2) To evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA. Methods and analysis Systematic searches of Medline, Embase, clinical trial registries, and other sources for all ongoing and completed randomised controlled trials comparing cord management strategies at preterm birth (before 37 weeks' gestation) have been completed up to 13 February 2019, but will be updated regularly to include additional trials. IPD will be sought for all trials; aggregate summary data will be included where IPD are unavailable. First, deferred clamping and cord milking will be compared with immediate clamping in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for prespecified participant subgroups. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes. Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored. Ethics and dissemination Ethics approval for this project has been granted by the University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline developers and policy-makers, and will be disseminated via publications, presentations and media releases. Registration number Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001305112) and International Prospective Register of Systematic Reviews (PROSPERO, CRD42019136640).

AB - Introduction Timing of cord clamping and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups. Previous and current trials compare various policies, including time-based or physiology-based deferred cord clamping, and cord milking. Individual participant data (IPD) enable exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons. Objectives (1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis. (2) To evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA. Methods and analysis Systematic searches of Medline, Embase, clinical trial registries, and other sources for all ongoing and completed randomised controlled trials comparing cord management strategies at preterm birth (before 37 weeks' gestation) have been completed up to 13 February 2019, but will be updated regularly to include additional trials. IPD will be sought for all trials; aggregate summary data will be included where IPD are unavailable. First, deferred clamping and cord milking will be compared with immediate clamping in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for prespecified participant subgroups. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes. Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored. Ethics and dissemination Ethics approval for this project has been granted by the University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline developers and policy-makers, and will be disseminated via publications, presentations and media releases. Registration number Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001305112) and International Prospective Register of Systematic Reviews (PROSPERO, CRD42019136640).

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Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): Study protocol

Résumé

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ASJC Scopus Subject Areas

ODD de l’ONU

Accès au document

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