400 infant BIRTHDAY!!
Congratulations to everyone for their hard work in the COIN trial. We have
on the 24th of July, recruited our 400th eligible infant!
To celebrate this milestone, I have packed some goodies for all to share.
Retrospective Data
We thank all
centres for completing the retrospective data.
Centres who have
not completed the retrospective data, please forward your data to the
coordinating centre as soon as possible.
Randomisation
A couple of infants
have recently been randomised with the randomisation envelope opened before
delivery. We remind all centers that randomisation envelopes are only to be
opened in the delivery room and only if the baby is eligible at 5 minutes.
Questions regarding COIN case report forms
1. B1a. “We have a number of Hispanic patients, but
they are not of European origin”, do you want them coded as “other”? Answer: Yes please
2. B2 and B3. “If a mom is treated with MgSO4 to suppress
labor, do you want both “tocolytic drugs” and “Magnesium sulphate” coded
as “yes”, or is the magnesium sulphate category only for treatment to prevent
seizures?” Answer:
If magnesium sulphate was given, tick the magnesium
sulfate box. If it was primarily given for tocolysis, tick the tocolytic box as
well. If it was given to treat toxaemia, do not tick the toxcolytic box.
3 C8. “If a baby receives just oxygen in the
delivery room without bag/mask, do you want resuscitation coded as “none”? An example.
If the baby received blow-by oxygen and then was placed on the neopuff
for the study, do we code “resuscitation” as “none” and “resuscitation device”
as “neopuff”?” Answer: A
bit complicated. If the baby is breathing easily and just given oxygen to help
it pick up but with no inflations or CPAP that would be coded none. However, if
the Neopuff was used to give any inflations then that would be coded “bag and
mask” and the device “Neopuff”
4. C8a. “Do you want any type of self-inflating bag
coded as an “anaesthetic” bag or do you want it coded as a “Laerdal” bag,
though it is not that brand, but similar in use? A little more detail on this would be
helpful.” Answer: A
self inflating bag is one that opens itself after you have squeezed it even if
there is no oxygen flowing into it. An anaesthetic bag is one that is soft and does
not reinflate after compression unless it has gas flowing in at several L/min
and the face mask is on the baby without too much leak. If you are using a self
inflating bag please code under Laerdal or Ambu.
5. “For Base Excess, do you want the
negative sign written in or just the whole number. Also, if the value is 0 or a positive number,
do you want NA written or just left blank?” Answer:
Please enter with a negative sign to prevent
confusion. If 0 that is important and not missing so please put whatever number
is on the blood gas form.
6. “Does “IA” refer to
indwelling arterial line or something else?
We do not recognize this. Also,
we use percutaneous central venous catheters (PSC or PICC), are you not
interested in these lines?” Answer: Sorry, so many
confusions in our form. IA is Intra-arterial (radial etc), UA mean umbilical
artery. UV means umbilical vein.
7 F1. “Please give us a more detailed description
of these different types of CPAP. Do you
want any brand of two prong coded as “
8. G2 and G3. “We had a baby who was intubated in the DR,
extubated to CPAP and then cannula all within the first 24 hours of life. Do we code
“1” day of ET and “1” day of CPAP?
If we do that, it will appear that the baby was on assisted ventilation
for 2 days when, in fact, he was not.
Should we be using a hierarchy and only record the highest level of
support for any one day?” Answer: Sorry about this confusion. In this randomised trail we are
not interested in fractions of a day. Please code ETT as 1 day and CPAP as 1
day and total days as 1 day! It would help if you wrote next to it what had
happened.
9. H6.
“Are you specifically looking for when the baby was at 150cc/k/day or
when the infant reached full feeding without IV fluids? We have infants who have their IV’s
discontinued prior to receiving 150cc/k of enteral feeds.” Answer: I agree we sometimes
have the IV down before 150 cc/kg/day. However, for the purpose of this trial
Full Feeds is 150 ml/kg/day and then sustained for at least 3 days. So please
wait until it reaches that level.
Calculating Age -
CRF
In this trial we
count the time of birth as day 0 and 0 hours. At 12 hours they are 0.5 days
old. At 36 hours they are 1.5 days old.
You need to look at
the time and date of birth and work out when they are 28 days using this
technique. The day of birth is day 0.
Non Randomised
infant forms
To make sure there
is no misunderstanding, please fill in a non-randomised infant form for every
baby who is born at 25 to 28 weeks gestation and does not get enrolled into the
COIN trial.
Data Monitoring
Committee
The data monitoring committee will be assessing 300 infants randomised to
the COIN Trial. This process will allow any untoward events to be recognized by an
independent data monitoring committee, experienced in perinatal clinical
trials. They will be asked to assess
whether either group has excessive rates of mortality, brain haemorrhages, air
leaks or other complications.
Interested Parties
Centres
considering joining the COIN Trial
|
|
< 2004 |
Jan |
Feb |
Mar |
Apr |
May |
Jun |
Jul |
Aug |
Total*^ |
|
(0) Royal Women’s Hospital, VIC, AUS |
132 |
3 |
2 |
3 |
3 |
0 |
2 |
1 |
0 |
146 |
|
(1) |
26 |
0 |
0 |
5 |
1 |
0 |
0 |
0 |
0 |
32 |
|
(2) The Royal Women's Hospital, QLD, AUS |
||||||||||
|
(3) Montefiore Medical |
18 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
21 |
|
(4) The National Women's, |
14 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
16 |
|
(6) PMH&
KEMH, WA, AUS |
25 |
1 |
1 |
1 |
0 |
2 |
1 |
0 |
0 |
31 |
|
(7) Mc Master
University, Canada |
12 |
0 |
0 |
1 |
0 |
4 |
|
0 |
0 |
17 |
|
(8) Alexandra
Hospital, Athens, Greece |
25 |
3 |
1 |
3 |
2 |
0 |
0 |
0 |
0 |
34 |
|
(9) |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
|
(11) |
6 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
|
(12) |
7 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
9 |
|
(13) Maternite Regionale Universitaire, |
14 |
1 |
2 |
3 |
0 |
2 |
1 |
3 |
0 |
26 |
|
(14)
Rikshospitalet University Hospital, Oslo, Norway |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
|
(15) |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
|
(16) Klinik
For Neonatologie Charite Berlin, Germany |
0 |
0 |
0 |
2 |
2 |
0 |
0 |
0 |
0 |
4 |
|
(17) The John Radcliffe, |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
(18) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
(19) Golisano Children’s Hospital at Strong, |
0 |
0 |
5 |
1 |
0 |
1 |
1 |
0 |
1 |
9 |
|
(20) B.C. Children’s |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
(21) Miller Children’s
Hospital, USA |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
(22) Univ. Hospital
Antwerp, Belgium |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
(23) Universitätsklinikums
Freiburg, Germany |
0 |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
0 |
3 |
|
Total |
317 |
15 |
13 |
20 |
10 |
11 |
9 |
5 |
1 |
401 |
Recruitments to
date – 199 babies to go!!!
* Please note some centres have only been recruiting
for a few months.
^ Recruitment by
baby’s date of birth, eligible babies only.
Completion
and Return of CRF
Infants to be Followed up in Year 2004
* Excluding infants
died.
^ Follow-ups
received by the coordinating centre.