Download - The SToP-BPD study
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The SToP-BPD study
Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants
Clinical lesson Oct 2011
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History of steroids in neonatology
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The Evidence
EC Eichenwald, AR Stark; Arch. Dis. Child. Fetal Neonatal Ed. 2007;92;334-337
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Furthermore…
• Consequence of publications on adverse neurological sequelae: late and low doses dexa
• Current policy Amsterdam: 1.4 mg/kg cumulative dose
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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
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Equipoise!
• Therefore, it is time for a nwe trial
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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
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Inclusion criteria
• GA < 30 wks and/or BW < 1250 g• Ventilator dependent between 7-14 d PNA• RI (MAwP x FiO2) ≥ 3.5
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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
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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
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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
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Medication program
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Study medication
• Pharmacy prepares medication• PDMS configuration• Medication per day prepared
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Rescue therapy
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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
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Late rescue treatment
• Patient still ventilator dependent after 22 d• Failed extubation attempt• Late rescue possible with HC according to
study protocol
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Documents for the Nurses
• Summary (also in French)
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Print out Daily reports
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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.
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Discharge from level III center
• Letter for paediatrician on the website (also in French)
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Oxygen reduction test
• Criteria: only defined by O2
• Dependent on saturation targets or other conditions
• Practical guideline on the website
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Questions?