HYDROCORTISONE FOR PREVENTING BRONCHOPULMONARY DYSPLASIA;
THE STOP-BPD STUDY
PARENT INFORMATION LETTER
Dear Sir, Madam,
Your baby has been admitted to the Neonatology Department because it was born
prematurely. All members of the medical team are currently doing their utmost to help your
child get through this difficult period in the best way possible. Your physician will undoubtedly
have told you that most treatment procedures we have at our disposal may not be without
adverse effects. Fortunately, we know that the benefits of many therapies far surpass their
disadvantages. There are also types of treatment, however, as yet unproven, which are
presumed to be more beneficial than detrimental. Proof for such a presumption can only be
obtained by conducting research, which will enable us to continually improve the level of care
we can offer premature babies.
The purpose of this letter is to inform you about an important clinical research study that is
currently being carried out at all neonatology departments in the Netherlands.
Background and object of the study
Your baby is still incapable of absorbing sufficient amounts of oxygen into its bloodstream
through independent breathing and has therefore been put on a respirator. Yet such artificial
respiration may cause damage to the baby’s immature lungs. If the damage becomes
extensive, a condition arises that we refer to as bronchopulmonary displasia, abbreviated to
BPD.
Babies with BPD require more time before they are able to breathe entirely on their own and
often need extra oxygen for a considerable period. During the first few years of their lives,
they may frequently suffer from pneumonia and shortness of breath, for which they will have
to take medicines. And if we look even further ahead, it becomes apparent that children with
BPD tend to lag behind in both physical and mental development in comparison with other
prematurely born children without BPD. So you will understand that we, as medical
practitioners, will do everything in our power to prevent BPD.
Administering adrenal gland hormone is one of the available methods of treatment. Two
types of adrenal gland hormone are currently used in the Netherlands: dexamethasone and
hydrocortisone. Research has brought to light that dexamethasone does reduce the
incidence of BPD, but this therapy may have significant side-effects, such as high blood
sugar levels, hypertension, gastro-intestinal problems, infections and, possibly, enhanced
probability of lagging behind in physical and mental development. There are strong
indications that hydrocortisone has fewer adverse effects, but we still lack conclusive proof
that this treatment actually decreases the risk of BPD.
That is why all 10 neonatology departments in the Netherlands have decided to look further
into hydrocortisone therapy for the prevention of BPD in premature babies. In total, over 400
children will participate in the study.
What children qualify for participation in the study?
Babies who are at risk of developing BPD. This includes children born after a pregnancy of
24 to 30 weeks and/or with birth weights lower than 1250 grams, who need supplemental
oxygen in the 2nd week of life.
What precisely does this study involve?
Babies participating in this study will receive either hydrocortisone therapy for 22 days or will
be given a so-called placebo (a substance without any medical effect) from their second
week of life. Which of the two types of treatment you baby will receive is unknown in
advance; it will be decided by drawing lots. The study will be conducted ‘double blind’, which
means that neither doctors, nurses nor parents will know which therapy is being administered
to your baby. Nothing will change in the further care or treatment of your baby. Nor will your
child be subjected to any additional examinations, although we will, of course, continue to
monitor your baby closely, recording lots of data during its stay at the hospital.
When your baby is 36 weeks old, counting from the mother’s last period (4 weeks prior to the
calculated date of birth), we will determine whether your child has a form of BPD.
As usual, your baby will have to be checked on a regular basis at the outpatient clinic of the
neonatology department. A development test will be performed 24 months after the
calculated date of birth. This data, too, will be incorporated into the study file.
How will the study impact your child and what are the pros and cons?
The medicine will be administered intravenously. Considering that most prematurely born
babies are on a drip anyway, administration will cause no extra impact on your child. Should
your baby no longer require a drip, hydrocortisone or placebo can also be given with food. As
mentioned previously, your child will continue to receive standard care and treatment, and no
additional examinations are required for this study.
A possible advantage of hydrocortisone therapy could be that your baby has a diminished
risk of developing BPD and thus a greater chance of avoiding all future problems associated
with the condition. A possible disadvantage of hydrocortisone therapy could be that your
baby might be exposed to an increased risk of side-effects brought on by adrenal gland
hormone use, such as high blood sugar levels, hypertension, gastro-intestinal problems,
infections and, possibly, enhanced probability of lagging behind in physical and mental
development.
It goes without saying that your child’s health is of paramount importance, which is why your
baby is closely monitored all the time. Your attending physician can decide at any time to
discontinue your baby’s participation in the study, if he/she thinks that a different type of
treatment is required, which falls outside the scope of this study. You will, of course, be
notified if such should be the case.
Parent Information Letter SToP-BPD Study. Version 2 05-01-2011. Academic Medical Centre Amsterdam.
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What do we request your permission for?
We ask your permission for your baby’s inclusion in this research study. Participation in the
study is entirely voluntary, which means that you can withdraw your child from the study at all
times, without any consequences for the treatment and care your child will receive. If your
child participates and should be transferred during the study to a hospital in your area, your
consent will also involve allowing us to retrieve data on the course of your child’s condition
during this part of the research study.
In addition, we would like to ask your permission to approach you at a later date, after the
study has been completed, for additional research.
Confidentiality of data
For reasons of privacy protection, all research and medical data will be recorded under code,
i.e. anonymously, and thus kept fully confidential. Your baby’s name will neither be used nor
made visible. The identity of study subjects can only be retrieved by the researchers and
attending physicians. It may be necessary, however, that certain parties be allowed to
inspect medical files for trial monitoring purposes, such as representatives from the AMC’s
Medical Ethics Committee or from the study’s initiator, the AMC, or duly authorised
government bodies. Access to the files is then granted under the responsibility of the
attending physician. If you consent to your child’s participation in this study, you
automatically agree to such inspections. Your child’s identity will never be disclosed for any
other reason. The data recorded within the scope of this study will be kept by us for 20 years
and then be destroyed. The AMC’s Medical Ethics Committee has given this clinical trial a
favourable opinion.
Insurance
In pursuance of Section 7 of the Dutch Medical Research Involving Human Subjects Act
(published in the 1998 Bulletin of Acts and Decrees, p. 161), insurance has been taken out
for the subjects participating in this study (see appendix). This insurance complies with the
stipulations set forth in the Decree on Compulsory Insurance of Medical Research Involving
Human Subjects (published in the 2003 Bulletin of Acts and Decrees, p. 266).
Further information
Should you have any further questions in regard to this study, you can contact one of the
responsible researchers at telephone number ..................................................................:
If you have any questions that you would rather not discuss directly with the researcher, you
can turn to an independent physician who is not involved in the conduct of this study. In this
case, the physician in question is ...................................................................., who can be
reached at telephone number ........................................................
On behalf of the national and local research team,
………………………………………………………..
Parent Information Letter SToP-BPD Study. Version 2 05-01-2011. Academic Medical Centre Amsterdam.
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Appendix: Information on AMC Amsterdam Insurance
Pursuant to the Dutch Act on Medical Research involving Human Subjects, the private limited liability
company AMC Medical Research B.V. has taken out insurance covering any and all fatal and nonfatal injuries suffered by subjects due to participation in clinical studies organised by the same.
1.
Any such injury as referred to above should become apparent and be reported during the
subject’s participation in a particular study or within four years thereafter.
2.
The sums insured amount to € 450,000 per subject, to a maximum of € 3,500,000 for the entire
study and a total of € 5,000,000 per insurance year for all reported injuries caused by any medical
research trials involving the company mentioned above.
The insurance provides cover:
1. for any injury sustained as a result of the realisation of any risk connected with participation in a
clinical study, of which the subject had not been notified in writing beforehand;
2. for any injury sustained as a result of the realisation of any risk in respect of which the subject had
in fact been notified, but the ramifications of which turned out to be more serious than anticipated;
3. for any injury sustained as a result of the realisation of any risk in respect of which the subject had
in fact been notified, but the occurrence of which was considered extremely unlikely.
The insurance does not provide cover:
1. for any injury resulting from the non-occurrence of any amelioration of a subject’s health problems
or from the further deterioration of the subject’s health, in the event that treatment of the subject’s
health problems is the reason for his or her participation in a particular trial;
2. for any injury resulting from any impairment of a subject’s health, which would most likely also
have occurred if the subject had not participated in the trial;
3. for any injury resulting from participation in a clinical trial involving comparisons of medical acts
customarily performed by medical professionals, where it is probable that the damage has been
caused by any such act;
4. for any injury revealing itself in a subject’s offspring and resulting from adverse effects of the study
on either the subject or the offspring of the same;
5. for any injury resulting from the subject’s complete or partial failure to follow directions and
instructions, provided that the subject is capable of doing so.
The insurance exclusively covers injuries sustained by natural persons.
Cover of specific injuries and expenses is limited to specified sums.
In order to qualify for compensation under the insurance, the subject is to lodge any and all personal
injury claims related to the study with:
Name of insurer:
Centramed B.A.
Address of insurer:
Prinses Beatrixlaan 35, 2595 AK The Hague, The Netherlands.
Policy number:
620.872.806
In regard to such matters, the subject is furthermore requested to contact:
Dr A.H. van Kaam: +31 (0)20-5663477 and Ms M.A. Mooijer +31 (0)20-5666264
Parent Information Letter SToP-BPD Study. Version 2 05-01-2011. Academic Medical Centre Amsterdam.
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