PROVIDE Trial Participant Information
Parent/Caregiver Information
Why my baby/pepi?
Your very small preterm baby/pepi will need a treatment called intravenous nutrition (food via a drip) to make sure they have enough nutrition before they are able to have milk feeds. We would like to invite you and your baby/pepi to take part in a study to look at whether giving more protein in the intravenous nutrition will improve the growth and development of very preterm babies. Your baby is eligible for this study because (s)he was born very small and preterm and has a catheter (called the umbilical artery catheter) placed into a blood vessel going through the umbilical cord to help with his/her care. Participation is voluntary (your choice). You do not have to take part in this study. If you choose not to take part this will not affect the care your baby/pepi receives in the newborn intensive care unit, or at any time in the future. If you do agree to take part, you are free to withdraw from the study at any time, without giving a reason. This will not affect your or your baby/pepi’s future health care.
Why is this study important?
Nutrition is very important for the growth and development of all babies. Preterm babies, who are less than 1000 g at birth, often have slower growth in their first weeks of life, and this might also relate to slower brain development. We need to know whether giving more protein in the first week of life improves growth and development of the brain.
What is the ProVIDe study?
The aim of the ProVIDe study is to compare the growth and development of babies who are given extra protein in the first 5 days of life with those of babies who are given the usual amount of protein. If your baby/pepi takes part, he or she will be randomly (by chance) assigned to either the standard fluid solution (control) or one containing extra protein through the umbilical artery catheter for the first 5 days after birth. The rest of your baby’s treatment, including nutrition, will be the same as if he/she were not taking part in this trial. If your baby/pepi is in the control group, his/her nutrition will be the same as is currently used at this hospital. Neither you nor the doctors and nurses looking after your baby/pepi will know which group he/she is in.
How will this affect your baby/pepi
If we have discussed this study with you before your baby/pepi was born, we are now asking if you agree for your baby/pepi to take part in this study.
If your baby/pepi was born unexpectedly, we will already have randomly assigned your baby to one of the two groups. This has been approved by the ethics committee because of the importance of understanding whether extra protein provided soon after birth is beneficial or not, but we must discuss the study with you within 24 hours. We are now asking if you will allow your baby to continue to take part in the study. If you do not agree to take part in the study, or if you are not able to make a decision within 24 hours after the birth of your baby/pepi, we will change the umbilical artery catheter solution to the one that is usually used and continue the normal clinical care as decided by the doctors caring for your baby/pepi. No blood samples will be collected for research purposes.
If you agree your baby/pepi can take part in the study we will take a small amount of extra blood (about ¼ teaspoon) on two occasions over the first week after birth to measure the effect of the treatment. Whenever possible this blood will be combined with a blood test that is already being taken for the clinical care of your baby and taken through the umbilical artery catheter meaning that no needle-prick is necessary. Samples will be stored in the laboratory until analysis in batches. Blood samples will be destroyed once the study is finished or if the sample has not been used after 5 years. We also will collect information about your baby’s progress from their medical records. Before your baby/pepi leaves NICU his/her body composition may be measured using a PEAPOD. This is a capsule that the baby is placed inside for a few minutes. Your baby will be observed throughout the procedure and you can be in the room too. There are no known adverse effects of this procedure.
All babies who are born as early as your baby are offered an appointment for a detailed assessment of development when they are about 2 years old. If you allow your baby/pepi to take part in the ProVIDe study, they will have some extra measurements at this visit to assess growth and development very thoroughly. We will measure their body composition by DXA. DXA is a machine that uses a small amount of radiation to measure body fat and muscle. The amount of radiation from a DXA scan is less than one day’s exposure to natural radiation. DXA scans are, therefore, believed to be completely safe. We will contact you before the appointment to see if you are happy for your baby/pepi to have these additional assessments.
What are the possible benefits and risks to my baby?
We are conducting this study because we do not know whether extra protein shortly after birth will be beneficial or not. This study may be of benefit to your baby/pepi if the extra protein does turn out to improve growth and development, but this is not yet known. There is a risk that the extra protein may not improve growth and brain development or that it may slow growth and development. We do not know how much protein is too much or too little and that is the reason for this study. The study will also benefit future babies born very small like yours, by helping find out the best nutrition for them. We will be assessing your baby/pepi’s growth and development and we will give you and/or your GP a summary of these assessments if you would like. Many parents find these assessments reassuring. If we discover any areas of concern we will discuss this with you and help you decide if any further help is needed.
There is a small risk of bruising or discomfort when blood is taken (not in the first week when it will be taken from the umbilical artery catheter). With additional blood tests there is a small risk of low blood iron levels and this might lead to a blood transfusion being needed. Very preterm babies require frequent blood tests to guide routine care in the neonatal unit and the additional blood tests will reflect a tiny proportion of the total tests taken. Thus, although very preterm babies often need several blood transfusions in the first few weeks it is unlikely that participation in this study will lead to a significantly increased requirement for transfusion. Healthy, voluntary donors have donated the blood used for transfusion. Babies very rarely develop any reaction to transfusion. Very rarely other problems can occur such as a transfusion reaction in which red cells are destroyed. In severe transfusion reactions kidney failure can occur – this is extremely rare. We do not think there are any significant risks to your baby/pepi if they take part in this study.
Results
We will discuss your child’s assessment results with you after the follow up visit and, if you agree, we will send a summary of the results to you and/or to your GP. If you have any concerns about your child’s health and would like the results sent to another health professional we can do that for you. The results from the completed study will be published in a scientific journal. The results will be presented in a way that does not identify you or your baby/pepi in any way. A summary of the results of the study will be sent to you if you show on the consent form that you would like to receive this. This is not likely to be before 2018.
What information will be requested from the Newborn Metabolic Screening Programme (sometimes called the heel prick test or Guthrie card)?
The Newborn Metabolic Screening Programme tests newborn babies through a heel prick test for over 20 disorders. This test includes analysing the blood for amino acids. If you agree, the results of amino acid testing will be requested and used for the purposes of this study. Further information on the Newborn Metabolic Screening Programme can be found at www.nsu.govt.nz.
Ethical approval
The Northern B Health and Disability Ethics Committee has given ethical approval (No 13/NTB/84) for this study. The Manager and the Clinical Director of Newborn Services, Auckland City Hospital have also given permission for this study to be carried out.
Compensation
In the unlikely event of a physical injury to you or your baby/pepi as a result of participation in this study, you may be covered by ACC. ACC cover is not automatic, and your case would need to be assessed by ACC according to the provisions of the Injury Prevention, Rehabilitation, and Compensation Act 2001. If your claim is accepted by ACC, you still may not get any compensation. This depends on factors, such as whether you are an earner or non-earner. ACC usually provides only partial reimbursement of costs and expenses. There may be no lump sum compensation payable. There is no cover for mental injury unless it is a result of physical injury. If you have ACC cover, generally this will affect your right to sue the investigators.
Questions
If you wish to know anything further about this study, at any stage, please ask your baby/pepi’s nurse or doctor or contact the lead researcher Barbara Cormack.
Further information
If you would like any further information about the study, you can contact one of the investigators or the nurse or doctor looking after your baby/pepi. If you need an interpreter, we will be pleased to arrange one. If you have any queries or concerns about your rights as a participant in this study, you may contact: National Health and Disability Advocacy Service (Phone 0800 555 050).
If you require Māori cultural support, talk to your whānau in the first instance. Alternatively you may contact the administrator for He KamakaWaiora (Provider Arm Team) by telephoning 09 486 8324 Ext 2324. If you have any questions or complaints about the study you may contact the Auckland and Waitematā District Health Boards Maori Research Committee or Maori Research Advisor by phoning 09 486 8920 Ext 3204.
You may also contact your local Maori Health Services:
Auckland City Hospital – He KamakaWaiora. Mobile: 021 348 432, Tel: (09) 307 4949 Ext 23939
Middlemore Hospital – Te Kaahui Ora. Tel: (09) 276 0138
Waikato Hospital – Te PunaOranga. Tel: (07) 839 8899 Ext 97528
Wellington Hospital – Whanau Care Services. Tel: (04) 385 5999 Ext 80948 or (04) 806 0948
Christchurch Women’s Hospital. Tel: (03) 364 4503
Dunedin Hospital – Maori Health Advocacy Tel: 0800 555050
Thank you for making the time to read about the ProVIDe study and considering whether you’d like to take part.
Local investigator: Barbara Cormack, Neonatal Dietitian, bcormack@adhb.govt.nz
Tel: +64 9 307 4949 Ext 23351 or Mobile: 021 915 158 (daytime) or 021 252 9469 (after hours)
Principal Investigator: Barbara Cormack, Neonatal Dietitian, bcormack@adhb.govt.nz
Tel: +64 9 307 4949 Ext 23351 or Mobile: 021 915 158 (daytime) or 021 252 9469 (after hours)
Auckland City Hospital, Private Bag 920 24, Auckland 1142, New Zealand
Overall Responsible Investigator: Professor Frank Bloomfield, Neonatal Consultant f.bloomfield@auckland.ac.nz
Tel: +64 9 307 4949, Ext 25326, Mobile: 021 497 598
Liggins Institute, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand