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The SToP-BPD study

S ystemic Hydrocortisone To P revent B roncho p ulmonary D ysplasia in preterm infants. The SToP-BPD study. 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….

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The SToP-BPD study

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  1. Systemic Hydrocortisone ToPrevent Bronchopulmonary Dysplasia in preterm infants The SToP-BPD study Clinical lesson Oct 2011

  2. History of steroids in neonatology

  3. The Evidence EC Eichenwald, AR Stark; Arch. Dis. Child. Fetal Neonatal Ed. 2007;92;334-337

  4. Furthermore… • Consequence of publications on adverse neurological sequelae: late and low doses dexa • Current policy Amsterdam: 1.4 mg/kg cumulative dose

  5. 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

  6. Equipoise! • Therefore, it is time for a nwe trial

  7. Objective of the study Investigate is hydrocortisone, initiated 7-14 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

  8. Inclusion criteria • GA < 30 wks and/or BW < 1250 g • Ventilator dependent between 7-14 d PNA • RI (MAwP x FiO2) ≥ 3.5

  9. 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

  10. 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

  11. Website at www.neonatologiestudies.nl (NNRN)

  12. 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

  13. Medication program

  14. Study medication Pharmacy prepares medication PDMS configuration Medication per day prepared

  15. Rescue therapy

  16. 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

  17. Late rescue treatment Patient still ventilator dependent after 22 d Failed extubation attempt Late rescue possible with HC according to study protocol

  18. Documents for the Nurses • Summary (also in French)

  19. Print out Daily reports

  20. Web-based Alert procedure Alert Procedure (automated email to stop-bpd@amc.nl) 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.

  21. Discharge from level III center • Letter for paediatrician on the website (also in French)

  22. Oxygen reduction test • Criteria: only defined by O2 • Dependent on saturation targets or other conditions • Practical guideline on the website

  23. Questions?

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