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22 May 2012
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| [ Print-friendly version ] |
| Australasian Collaborative Trial of repeat doses of corticosteroids for the prevention of neonate respiratory disease |
| ISRCTN | ISRCTN48656428 |
| ClinicalTrials.gov identifier | |
| Public title | Australasian Collaborative Trial of repeat doses of corticosteroids for the prevention of neonate respiratory disease |
| Scientific title | |
| Acronym | ACTORDS |
| Serial number at source | N/A |
| Study hypothesis |
Primary hypotheses:
Prenatal administration of repeat doses of corticosteroids at weekly intervals to women who remain at risk of preterm birth at less than 32 weeks gestation: 1. Reduces the risk of neonatal lung disease 2. Adversely affects fetal and neonatal measures of growth Secondary hypothesis: Prenatal administration of repeat doses of corticosteroids at weekly intervals to women who remain at risk of preterm birth at less than 32 weeks gestation increases the risk of maternal infection |
| Lay summary | |
| Ethics approval | Not provided at time of registration. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Australia |
| Disease/condition/study domain | Neonate respiratory distress syndrome |
| Participants - inclusion criteria |
1. Women with a singleton, twin or triplet pregnancy
2. Gestational age less than 32 weeks who have received initial treatment of corticosteroid seven or more days ago 3. Responsible clinician considers her to be at continued risk of preterm birth 4. Informed, written signed consent 5. No contraindication to further corticosteroid therapy |
| Participants - exclusion criteria |
1. Women with chorioamnionitis requiring urgent delivery
2. Women in whom the L/S ratio or equivalent test, if determined, is judged to be mature 3. Women who are in the second stage of labour 4. Women in whom corticosteroid therapy is considered essential 5. No contraindication to further corticosteroid therapy |
| Anticipated start date | 01/01/1998 |
| Anticipated end date | 31/12/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | Not provided at time of registration. |
| Interventions | 11.4 mg Celestone Chronodose or saline placebo |
| Primary outcome measure(s) |
Neonatal respiratory outcomes:
1. Birthweight 2. Length and head circumference at birth 3. Primary discharge from hospital |
| Secondary outcome measure(s) |
On the mother:
1. Clinical chorioamnionitis requiring intrapartum antibiotics, maternal postpartum pyrexia greater than 38.0°C 2. Other measures of morbidity On the infant: Other measures of foetal and neonatal morbidity. |
| Sources of funding | National Health and Medical Research Council Project (Australia) (ref: 980185) |
| Trial website | |
| Publications |
Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16765760 2. http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&list_uids=17881750 |
| Contact name | Prof Caroline Crowther |
| Address |
University of Adelaide
Womens and Childrens Hospital 72 King William Road |
| City/town | North Adelaide |
| Zip/Postcode | 5006 |
| Country | Australia |
| Tel | +61 (0)8 8161 7647 |
| Fax | +61 (0)8 8161 7652 |
| caroline.crowther@adelaide.edu.au | |
| Sponsor | The University of Adelaide (Australia) |
| Address | - |
| City/town | Adelaide |
| Zip/Postcode | SA 5006 |
| Country | Australia |
| Tel | +61 (0)8 8161 7647 |
| Fax | +61 (0)8 8161 7652 |
| caroline.crowther@adelaide.edu.au | |
| Date applied | 18/03/2005 |
| Last edited | 26/09/2007 |
| Date ISRCTN assigned | 17/06/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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