Transcript Surfactant and lung protection

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
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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
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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):
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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:
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Occurrence of a SUSAR
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Death
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Simultanousely using indomethacine/ibuprofen and study medication
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Occurrence of an solitary intestinal perforation
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Occurrence of hypertension, as defined in protocol
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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?