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The SToP-BPD study Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants Clinical lesson Oct 2011 History of steroids in neonatology The Evidence EC Eichenwald, AR Stark; Arch. Dis. Child. Fetal Neonatal Ed. 2007;92;334-337 Furthermore… • Consequence of publications on adverse neurological sequelae: late and low doses dexa • Current policy Amsterdam: 1.4 mg/kg cumulative dose Hydrocortison • Netherlands: 4 centra administer hydrocortison, 6 dexa in low doses • HC: No prospective studies on risk:benefit ratio • Retrospective studies – No adverse effects neurological outcome (no placebogroup) – Case control compared to dexa no decreased effect fot the lungs Equipoise! • Therefore, it is time for a nwe trial Objective of the study • Investigate is hydrocortisone, initiated 714 d after birth, reduces the combined outcome of death or BPD at 36 wks PMA • Investigate if a possible beneficial effect on BPD is not with (unacceptable) increased adverse effects Inclusion criteria • GA < 30 wks and/or BW < 1250 g • Ventilator dependent between 7-14 d PNA • RI (MAwP x FiO2) ≥ 3.5 Exclusion criteria • • • • Chromosomal abnormalities Congenital pulmonary abnormalities Congenital neurological abnormalities Steroid treatment prior to inclusion with the purpose to improve the pulmonary function – NB not hypotension Randomization • • • • Possible between 7-14 d PNA Hydrocortison or placebo 22 dg First dose within 24 hr after inclusion Twins can be allocated to the same group – Procedure on the website Website at www.neonatologiestudies.nl (NNRN) Medication • HC course – Hydrocortisone Cumul. dose 72,5 mg/kg (=2.5 mg/kg dexa): • • • • 5 mg/kg/d in 4 times for 7 d 3,75 mg/kg/d in 3 times for 5 d 2,5 mg/kg/d in 2 times for 5 d 1,25 mg/kg/d in 1 once daily for 5 d • Placebo mannitol as base (pH and Osmol HC) • Medication kit contains of 23 vials • Totale duration 22 days Medication program Study medication • Pharmacy prepares medication • PDMS configuration • Medication per day prepared Rescue therapy Treatment failure of vroege rescue • Reason for consideration open label rescue: – deterioration with RI>10 for >6 uur – No improvement (RI<10) and: • At least 10 dys study medication • Failure extubation attempt < 24 hr before starting rescue • Rescue with HC according to study schedule and stop study medications Late rescue treatment • Patient still ventilator dependent after 22 d • Failed extubation attempt • Late rescue possible with HC according to study protocol Documents for the Nurses • Summary (also in French) Print out Daily reports Web-based Alert procedure Alert Procedure (automated email to [email protected]) should be used when: • Occurrence of a SUSAR • Death • Simultanousely using indomethacine/ibuprofen and study medication • Occurrence of an solitary intestinal perforation • Occurrence of hypertension, as defined in protocol • Use of open label hydrocortisone Reporting should be done < 72 hr of becoming aware ot the event. Discharge from level III center • Letter for paediatrician on the website (also in French) Oxygen reduction test • Criteria: only defined by O2 • Dependent on saturation targets or other conditions • Practical guideline on the website Questions?