Repeat prenatal corticosteroid prior to preterm birth: A systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: Assessing the effects using the best level of evidence) - study protocol

Caroline A. Crowther, Fariba Aghajafari, Lisa M. Askie, Elizabeth V. Asztalos, Peter Brocklehurst, Tanya K. Bubner, Lex W. Doyle, Sourabh Dutta, Thomas J. Garite, Debra A. Guinn, Mikko Hallman, Mary E. Hannah, Pollyanna Hardy, Kimberly Maurel, Premasish Mazumder, Cynthia (Cindy) McEvoy, Philippa F. Middleton, Kellie E. Murphy, Outi M. Peltoniemi, Dawn PetersLisa Sullivan, Elizabeth A. Thom, Merryn Voysey, Ronald J. Wapner, Lisa Yelland, Sasha Zhang

Research output: Contribution to journalArticle

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Abstract

Background: The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol.Methods/Design: The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia).Discussion: Data analyses are expected to commence in 2011 with results publicly available in 2012.

Original languageEnglish (US)
Article number12
JournalSystematic Reviews
Volume1
Issue number1
DOIs
StatePublished - Feb 12 2012

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Premature Birth
Meta-Analysis
Adrenal Cortex Hormones
Fever
Sepsis
Outcome Assessment (Health Care)
Periventricular Leukomalacia
Anti-Bacterial Agents
Chorioamnionitis
Retinopathy of Prematurity
Necrotizing Enterocolitis
Continuous Positive Airway Pressure
Fetal Death
Deafness
Cerebral Palsy
Blindness
Clinical Protocols
Intelligence
Hearing Loss
Artificial Respiration

ASJC Scopus subject areas

  • Medicine (miscellaneous)

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Repeat prenatal corticosteroid prior to preterm birth : A systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: Assessing the effects using the best level of evidence) - study protocol. / Crowther, Caroline A.; Aghajafari, Fariba; Askie, Lisa M.; Asztalos, Elizabeth V.; Brocklehurst, Peter; Bubner, Tanya K.; Doyle, Lex W.; Dutta, Sourabh; Garite, Thomas J.; Guinn, Debra A.; Hallman, Mikko; Hannah, Mary E.; Hardy, Pollyanna; Maurel, Kimberly; Mazumder, Premasish; McEvoy, Cynthia (Cindy); Middleton, Philippa F.; Murphy, Kellie E.; Peltoniemi, Outi M.; Peters, Dawn; Sullivan, Lisa; Thom, Elizabeth A.; Voysey, Merryn; Wapner, Ronald J.; Yelland, Lisa; Zhang, Sasha.

In: Systematic Reviews, Vol. 1, No. 1, 12, 12.02.2012.

Research output: Contribution to journalArticle

Crowther, CA, Aghajafari, F, Askie, LM, Asztalos, EV, Brocklehurst, P, Bubner, TK, Doyle, LW, Dutta, S, Garite, TJ, Guinn, DA, Hallman, M, Hannah, ME, Hardy, P, Maurel, K, Mazumder, P, McEvoy, CC, Middleton, PF, Murphy, KE, Peltoniemi, OM, Peters, D, Sullivan, L, Thom, EA, Voysey, M, Wapner, RJ, Yelland, L & Zhang, S 2012, 'Repeat prenatal corticosteroid prior to preterm birth: A systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: Assessing the effects using the best level of evidence) - study protocol', Systematic Reviews, vol. 1, no. 1, 12. https://doi.org/10.1186/2046-4053-1-12
Crowther, Caroline A. ; Aghajafari, Fariba ; Askie, Lisa M. ; Asztalos, Elizabeth V. ; Brocklehurst, Peter ; Bubner, Tanya K. ; Doyle, Lex W. ; Dutta, Sourabh ; Garite, Thomas J. ; Guinn, Debra A. ; Hallman, Mikko ; Hannah, Mary E. ; Hardy, Pollyanna ; Maurel, Kimberly ; Mazumder, Premasish ; McEvoy, Cynthia (Cindy) ; Middleton, Philippa F. ; Murphy, Kellie E. ; Peltoniemi, Outi M. ; Peters, Dawn ; Sullivan, Lisa ; Thom, Elizabeth A. ; Voysey, Merryn ; Wapner, Ronald J. ; Yelland, Lisa ; Zhang, Sasha. / Repeat prenatal corticosteroid prior to preterm birth : A systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: Assessing the effects using the best level of evidence) - study protocol. In: Systematic Reviews. 2012 ; Vol. 1, No. 1.
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abstract = "Background: The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol.Methods/Design: The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia).Discussion: Data analyses are expected to commence in 2011 with results publicly available in 2012.",
author = "Crowther, {Caroline A.} and Fariba Aghajafari and Askie, {Lisa M.} and Asztalos, {Elizabeth V.} and Peter Brocklehurst and Bubner, {Tanya K.} and Doyle, {Lex W.} and Sourabh Dutta and Garite, {Thomas J.} and Guinn, {Debra A.} and Mikko Hallman and Hannah, {Mary E.} and Pollyanna Hardy and Kimberly Maurel and Premasish Mazumder and McEvoy, {Cynthia (Cindy)} and Middleton, {Philippa F.} and Murphy, {Kellie E.} and Peltoniemi, {Outi M.} and Dawn Peters and Lisa Sullivan and Thom, {Elizabeth A.} and Merryn Voysey and Wapner, {Ronald J.} and Lisa Yelland and Sasha Zhang",
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T2 - A systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: Assessing the effects using the best level of evidence) - study protocol

AU - Crowther, Caroline A.

AU - Aghajafari, Fariba

AU - Askie, Lisa M.

AU - Asztalos, Elizabeth V.

AU - Brocklehurst, Peter

AU - Bubner, Tanya K.

AU - Doyle, Lex W.

AU - Dutta, Sourabh

AU - Garite, Thomas J.

AU - Guinn, Debra A.

AU - Hallman, Mikko

AU - Hannah, Mary E.

AU - Hardy, Pollyanna

AU - Maurel, Kimberly

AU - Mazumder, Premasish

AU - McEvoy, Cynthia (Cindy)

AU - Middleton, Philippa F.

AU - Murphy, Kellie E.

AU - Peltoniemi, Outi M.

AU - Peters, Dawn

AU - Sullivan, Lisa

AU - Thom, Elizabeth A.

AU - Voysey, Merryn

AU - Wapner, Ronald J.

AU - Yelland, Lisa

AU - Zhang, Sasha

PY - 2012/2/12

Y1 - 2012/2/12

N2 - Background: The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol.Methods/Design: The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia).Discussion: Data analyses are expected to commence in 2011 with results publicly available in 2012.

AB - Background: The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol.Methods/Design: The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia).Discussion: Data analyses are expected to commence in 2011 with results publicly available in 2012.

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