IMP Management

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Study overview

A multi-centre, randomised, placebo-controlled

trial to determine health and economic outcomes

of the treatment of a large Patent Ductus

Arteriosus (PDA)

in extremely preterm babies with ibuprofen within

72 hours of birth

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Research Question

Whether the pharmacological closure of a large

PDA (identified by echocardiography) with

ibuprofen within 72 hours of birth, improves short

and long term health and economic outcomes, in

extremely preterm babies.

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Trial intervention stock

control

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Investigational Medicinal

Product (IMP)

• Treatment allocation of ibuprofen to placebo will be in a

ratio of 1:1 and concealed

• Each carton will be labelled with a unique randomisation

code number

• Ibuprofen will be supplied as a clear sterile solution of

Sodium Chloride at a concentration of 5 mg/ml in 2 ml

ampoules (4 ampoules/pack)

• Placebo will be supplied as a clear sterile solution of

0.9% Sodium Chloride solution for injection.

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IMP• All 3 doses will be given unless there are adverse effects

necessitating stoppage.

• Doses are to be calculated on the birth weight of the

baby.

• Each dose is to be given as a short intravenous infusion

over 15 minutes.

• Following randomisation; dosing should be started after 6

hours of age and within 72 hours of birth.

• Subsequent doses (if withheld); Timings?

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IMP administration• Routine practice

• Ibuprofen or placebo is an Investigational Medicinal

Product and must be prescribed electronically, or on the

baby’s drug chart to be given by intravenous injection using

the wording – ‘Baby-OSCAR clinical trial intervention, loading dose 2.0 mL/kg,

maintenance doses two and three, 1 mL/kg, P1234’

• Dosage & administration

• Given alongside other medications, or separate

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Summary

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“Baby-OSCAR clinical

trial intervention,

loading dose 2.0

mL/kg, maintenance

doses two and three, 1

mL/kg, P1234”

Unused ampoules, disposal

and accountability

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Breakages/spoilt ampoules• Packs of trial medication must only be administered to

the baby to whom it was allocated.

– Discard the broken/spoilt ampoule(s)

– record it/them on the IMP ‘Accountability Log’

• Log onto the website and re-allocate another trial

medication pack

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Unmasking/envelopes

• In the event of an emergency, a baby may be unmasked

by the clinician at the recruiting site

– log in to the randomisation website using a single-use access

code

– code provided in a sealed envelope, kept in ‘Site File’.

• The reason for unmasking must be recorded.

• Clinicians are reminded to exercise discretion when the

allocation has been unmasked.

• Continuing care sites:

– the treating health care professional should contact the PI or any

clinician on the delegation log at the recruiting site to unmask.

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Proposed packaging

Packs are L 108.5 mm x W 30.5 mm x H 82 mm.

Open treatment

• MINIMISE CONTAMINATION

• Surgical treatment however should only be

considered if

– the PDA remains persistently large after one

course of treatment with a COX inhibitor, or

– in circumstances where medical treatment

may be contraindicated, or

– time does not permit open treatment first

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Test website• Pharmacy staff have different user functions compared

with neonatal staff

• Encourage Pharmacy to practice:

− Looking at the number of packs at this hospital

− Login packs at NICU

• URL website: https://rct.npeu.ox.ac.uk/babyoscardemo/login.php

− Centre: Centre1 (select any centre from the list)

− Username: Pha_Centre1 (use the centre you selected as

username)

− Password: baby-oscar (for all sites)

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Contact details

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