EPICure 2
A study of extreme
prematurity in 2006
Principal Investigator for EPICure 2 Study: Professor Kate Costeloe
Neonatal Unit
Homerton University Hospital NHS Trust
Homerton Row, London E9 6SR
Tel: 020-8510-7544
Fax: 020-8510-7850
Email: [email protected]
EPICure 2 NEWSLETTER
ISSUE NO. 8 – NOVEMBER 2007
Dear Colleague
It is several months since we last updated you about EPICure 2. The team here at Homerton is now diminished and
comprises just myself supported by Fiona Stacey who is working half-time. As you will realise we have been
concentrating on trying to collect any outstanding data and chasing queries arising from data that we have already
received.
The purpose of this newsletter is to update you on the status of data collection, to summarise the presentation that we
gave to the annual meeting of BAPM in September and to let you know about future plans for dissemination of results.
Data Collection
This is good and, as ever, we are very grateful for all the fantastic work that has been done. Our latest estimate is
that we will have collected information about 3952 births (this number includes terminations) and 1692 admissions to
neonatal units. We still are hearing about a few new cases that have been overlooked so these numbers might go up
a little bit but not very much.
The table below summarises the data collection:
PN:E2 forms
(completed for all births)
Total number expected
Number received
3952
3884 (98%)
CRF forms
(completed for all babies admitted
to Neonatal Units)
1692
1606 (95%)
This represents a fantastic effort but we still have our sights on 100%! The problem is that it’s always the last few
that are the most difficult to collect!
PLEASE, if you know that you still have some forms for us could you please send them to us as soon as possible, even
if they are gaps in the data. Similarly, if by any chance you still have babies on your unit born before 26+6 weeks in
2006 it would be helpful if you could let us know.
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If any of you are in real difficulty with getting these data to us could you please let us know if there is anything we can
do to help. Fiona is only part-time now but we know how difficult it is and quite understand if we need to come to
some hospitals to help extract data from notes.
Parental Consent
I know that some of you are still planning to gain consent for use of data and for us keeping in touch with the families
when you see them in Outpatients. Many thanks for doing this, it is clearly preferable for the study to be discussed
with the parents by a paediatrician that they know rather than for them to receive a letter from the EPICure office out
of the blue. However, there are a lot of families from whom consent has not been sought. It was originally agreed
with the Research Ethics Committee that we should contact these parents directly and we will be doing this around
Christmas time this year when the parents of all the families who have consented will also be contacted and sent
information about the next phase of the study.
Next Stages
The oldest children in the EPICure 2 cohort were born at the beginning of January 2006 and so they start having their
second birthdays in January 2008. Neil Marlow is busy planning the next stages of the study which will be coordinated from the EPICure office in Nottingham by Heather Palmer ([email protected]). The detailed
application is about to go to the Research Ethics Committee. It is planned to send a simple questionnaire to all of the
parents who have given consent at around the time of the child’s second birthday. At the same time they will be given
more details about the full assessment that will be carried out by a designated paediatrician when the child is 2½.
The numbers of children are higher than they were in the first EPICure study and the plan is to offer a full assessment
to all of those surviving children who were born before 25+6 weeks plus a random selection of those who were born
between 26+0 and 26+6 weeks. The 2½year assessment will be very similar to that which was carried out in 1995 so
that we can make a direct comparison. When the 2½ year assessment is complete a copy of the report will be sent
from the EPICure office in Nottingham to the paediatrician we believe is responsible for the child’s care.
Summary of September Presentations
Three presentations describing preliminary results from EPICure 2 were shown to the annual general meeting of the
British Association of Perinatal Medicine in September. The first was given by Dr Liz Draper who gave a preliminary
overview of the information that you have sent us on the Unit Profile Study Forms – we’re still missing 3 of these and I
will be calling the relevant hospitals soon to try to get those in.
Liz gave a simple comparison of the new data with the aggregated data from the 1996 UK Neonatal Staffing Study
(that covered the whole of the UK whereas EPICure2 is restricted to England). It would appear that there is probably
an increase in the number of VLBW babies admitted to units. Cot numbers seem not to have changed much but there
seems to have been about a 50% increase in the numbers of babies receiving mechanical ventilatory support and over
100% increase in the total days of mechanical support (IPPV + CPAP). There also seems to have been some
improvement in the number of units that achieve recommended nursing ratios. A more useful analysis will be possible
when we have Ethical Committee approval to release the data for individual units from the previous study so that we
can do a direct comparison with English units and we’ll let you know about this in due course.
Zarko Alfirevic and I then presented some preliminary results from the clinical data collection. We were able to
present outcomes for the 73% of the total admitted data whose data had been checked, entered onto the computer
and whose gestational age it had been possible to validate. The numbers are already large and, although the details
will change, the overall messages that we presented in September are most unlikely to change.
The headline is that there appears overall to have been an increase in survival of babies admitted to neonatal units
born before 26 completed weeks gestation of around 10%.
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In the 1995 study we didn’t have sufficient information to be able to validate gestational age for the babies who were
still born or who died on labour wards but for the new study we do have that information so in the fullness of time we
will be able to give more accurate numbers for the admission rates and survival rates of fetuses alive on the onset of
labour.
The proportion of surviving babies to have major neonatal morbidity (treated Retinopathy of Prematurity, oxygen
dependence at 36 weeks post-menstrual age, hydrocephalus or parenchymal cysts on cerebral ultrasound scans)
seems not to have reduced since 1995. We reported increases in the number of children having retinopathy treated
and going home in oxygen but it is, of course, possible that this reflects change in clinical practice rather than
increased disease severity.
Future Plans for Data Dissemination
We will be submitting abstracts to the Spring meeting of the RCPCH in York and to the neonatal meeting to be held in
Harrogate in June 2008 describing neonatal outcomes and obstetric details of the population in greater detail. Those
presentations will be on a larger number of babies than the presentations that we gave for BAPM. After that we do not
plan to do any further interim analyses but to complete the data collection and then to prepare the data for
publication. We hope to be able to begin to submit papers early next year and will let you know when final results
begin to become available.
Again very many thanks to everyone and please let us know if we can do anything to help with the last bits of data
collection.
Best wishes to all,
Kate Costeloe
Fiona’s contact details:
Fiona Stacey, Research Neonatal Sister
Tel: 020-8510-7854
Email: [email protected]
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