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| [ Print-friendly version ] |
| Trial of the effects of antenatal multiple courses of steroids versus a single course (TEAMS): pilot study |
| ISRCTN | ISRCTN46614711 |
| DOI | 10.1186/ISRCTN46614711 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Trial of the effects of antenatal multiple courses of steroids versus a single course (TEAMS): pilot study |
| Scientific title | |
| Acronym | TEAMS |
| Serial number at source | SP3402 |
| Study hypothesis | In women judged clinically to be at ‘high risk‘ of preterm delivery the policy of administering more than one course of antenatal corticosteroids does not reduce perinatal death, respiratory distress syndrome and intraventricular haemorrhage in neonates and has a long term adverse effect on later health and development when compared with a single course. |
| Lay summary | Not provided at time of registration |
| Ethics approval | The protocol was approved by the Multicentre Research Ethics Committee on 8th September 1999 (ref: 98/5/70) |
| Study design | Randomised controlled trial |
| Countries of recruitment | Italy, United Kingdom |
| Disease/condition/study domain | Women at high risk of preterm delivery |
| Participants - inclusion criteria |
Women who have already received one course of antenatal steroids to improve foetal maturity and:
1. There is clinical uncertainty that a second course of steroids is indicated, and 2. Gestational age is less than 32 weeks |
| Participants - exclusion criteria | Maternal long term systemic corticosteroid therapy (not including inhaled or topical therapy). |
| Anticipated start date | 01/01/2000 |
| Anticipated end date | 01/04/2003 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 600 women in approximately 50 centres |
| Interventions |
Women meeting the inclusion criteria and giving informed consent to participate in TEAMS will be randomised to receive either:
1. Two intramuscular injections of betamethasone 2. Placebo 12 - 24 hours apart The number of courses depends on the risk of preterm delivery. |
| Primary outcome measure(s) |
1. Neonatal death
2. Neurodevelopmental delay at age 2 years (corrected for gestational age at birth) |
| Secondary outcome measure(s) |
Short term outcomes:
1. Stillbirth 2. Death at any time before discharge from neonatal unit 3. Diagnosis of respiratory distress syndrome 4. Pneumothorax or other pulmonary airleak 5. Intraventricular haemorrhage confirmed by ultrasound 6. Diagnosis of necrotising enterocolitis 7. Chronic lung disease (oxygen dependency at 28 days of life) 8. Neonatal sepsis 9. Birthweight 10. Maternal sepsis Long term outcomes: 1. Growth delay at age 2 (corrected) 2. Respiratory symptoms at age 2 years (corrected) 3. Sub-scale scores for the Vineland Adaptive Behaviour Scales and Bayley II Scales at age 2 years (corrected) 4. Readmission to hospital Measures of health service utilisation: 1. Admission to, and duration of stay in, a neonatal intensive care unit 2. Use of, and length of time on, mechanical ventilation 3. Use of surfactant, postnatal corticosteroids, high frequency oscillation, nitric oxide and Extra Corporeal Membrane Oxygenation (ECMO) |
| Sources of funding | Action Medical Research (UK) |
| Trial website | http://www.npeu.ox.ac.uk/teams/ |
| Publications | |
| Contact name | Ms Helen Adams |
| Address |
TEAMS Administrator
NPEU Institute of Health Sciences Old Road Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 7LF |
| Country | United Kingdom |
| Tel | +44 (0)1865 227000 |
| Sponsor | Action Medical Research (UK) |
| Address | Vincent House |
| City/town | Horsham West Sussex |
| Zip/Postcode | RH12 2DP |
| Country | United Kingdom |
| Sponsor website: | http://www.action.org.uk/ |
| Date applied | 01/03/2001 |
| Last edited | 03/11/2011 |
| Date ISRCTN assigned | 01/03/2001 |
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| © 2013 ISRCTN unless otherwise stated. | |
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