@article{effda84514c249b7ab936c42abde12a8,
title = "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",
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 Cindy McEvoy 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",
note = "Funding Information: The PRECISE Group The PRECISE IPD Project Team CAC (chair), PFM (epidemiologist), LMA (advice on IPD methodology), LWD (advice on paediatric aspects), TKB (project coordinator), LY (PRECISE coordinating statistician). The PRECISE Data Management Group LY (lead statistician), SZ (data management centre), MV (IPD statistical advisor), EAT (participating trial), PH (participating trial). The PRECISE Trialist Group Antenatal rescue course of glucocorticoid in threatened preterm birth (ANC Trial): MH and OMP; Australasian Collaborative Trial of Repeat Doses of Corticosteroids For the Prevention of Neonatal Respiratory Distress (ACTORDS): CAC and LWD; Impact of a {\textquoteleft}rescue course{\textquoteright} of antenatal corticosteroids: a multicenter randomised placebo-controlled trial (Rescue Course Trial): TJG and KM; Multiple courses of antenatal corticosteroids for preterm birth (MACS): a randomised controlled trial: KEM and EVA; Multiple versus single courses of antenatal corticosteroids for preterm birth: a pilot study: FA and MEH; Respiratory compliance in preterm infants after a single rescue course of antenatal steroids: a randomised controlled trial: CM and DP; Single courses versus multiple courses of antenatal betamethasone: a randomised controlled trial: SD and PM; Single versus weekly courses of antenatal corticosteroids for women at risk of preterm birth: a randomised controlled trial (Guinn Trial): DAG and LS; Single versus weekly courses of corticosteroids (US NICHD MFM Network Trial): RJW and EAT; The effect of a single remote course versus weekly courses of antenatal corticosteroids on functional residual capacity in preterm births: CM and DP; Trial of the effects of antenatal multiple courses of steroids versus a single course (TEAMS): PB and PH. The National Health and Medical Research Council (NHMRC) is funding the PRECISE IPD Study through a project grant. This funding will support the collection of the individual participant data by the original investigators, data management and analyses and to organise the collaborators{\textquoteright} meetings. The NHMRC is not involved in any other aspect of the project, such as the design of the project{\textquoteright}s protocol and analysis plan, the collection and the analyses of the project{\textquoteright}s data, or the interpretation and the publication of the study results.",
year = "2012",
month = feb,
day = "12",
doi = "10.1186/2046-4053-1-12",
language = "English (US)",
volume = "1",
journal = "Systematic Reviews",
issn = "2046-4053",
publisher = "BioMed Central",
number = "1",
}