Trial of the effects of antenatal multiple courses of steroids versus a single course (TEAMS): pilot study

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2001
INTERVENTION: 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. CONDITION: Women at high risk of preterm delivery ; Pregnancy and Childbirth ; Pregnancy PRIMARY OUTCOME: 1. Neonatal death; 2. Neurodevelopmental delay at age 2 years (corrected for gestational age at birth) SECONDARY OUTCOME: 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) 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
Epistemonikos ID: 924036ff4b90927d4701a59f6fb2660731619b70
First added on: Aug 21, 2024