Dr Gemma Sullivan
Department of Neonatology
Simpson Centre for Reproductive Health
Royal Infirmary of Edinburgh, Little France, Edinburgh EH16 4SA
About the study
Sometimes babies encounter problems during labour and delivery and their hearts stop beating. These babies have a reduced supply of blood and oxygen to their brain and require help in getting their heart to start again. This process is known as resuscitation and is required immediately after birth. If the lack of blood and oxygen is severe, it can cause injury to the brain that can be fatal, or may leave survivors with long term disabilities.
International guidance advises clinicians to consider stopping resuscitation if the heartbeat does not return by 10 minutes. This is based on studies reporting that the risk of death or serious disability for these babies is very high. However, the studies describe babies born more than 10 years ago. In recent years, the introduction of cooling treatment for babies who suffer a brain injury around the time of birth has improved the outlook for survivors. It may be that this guidance is no longer appropriate.
We aim to identify babies born at term in the UK and Republic of Ireland who receive prolonged resuscitation after delivery and have no heart rate detected at 10 minutes. We will describe how many of these babies survive and whether or not they have long term problems with development as they grow up.
This study will provide important information on the outlook for these babies and help to ensure that decisions regarding resuscitation and ongoing intensive care are made in the best interests of babies and their families.
Any baby who has been cared for in the last month for whom all three of the following conditions were met:
- Gestational age 37 or more completed weeks of gestation
- Cardiopulmonary resuscitation following delivery
- No heart rate detected at 10 minutes of age
Please report any cases of babies meeting the surveillance case definition whom you have seen in the last month in the UK or the Republic of Ireland.
November 2020 to November 2022 (25 months of surveillance)
Follow up until November 2024 (2 years follow up).
This study has been approved by South East Scotland Research Ethics Committee 01 (reference: 17/SS/0009); HRA Confidentiality Advisory Group (reference: 19/CAG/0002); and Public Benefit and Privacy Panel for Health and Social Care (reference: 1819-0054).
NHS Lothian is the sponsor and data controller for this research study. To contact the Data Protection Officer at NHS Lothian can be contacted at firstname.lastname@example.org.
The study team at NHS Lothian will use information from medical records for a medical research study. The lawful basis for collecting and using personal information in this study is article 6(1)(e) and article 9(2)(j) of the GDPR which allows us to process personal data when it is for scientific research in the public interest. We will collect information about term babies who are resuscitated term babies with no heart rate detected at 10 minutes of age from the doctors who are looking after them. Doctors will not provide identifying information like names and addresses, but they will provide personal information like sex, ethnic group and date of birth. The smallest amount of personal information will be used. We cannot withdraw or remove information from the study but personal information will be deleted or de-personalised when the study finishes. NHS Lothian will securely store this information for 20 years.
If you want access to the information in your child’s NHS records, then you should contact your child’s NHS hospital/doctor.
If you want to find out more about how personal information is used in the study, please contact email@example.com.
If you wish to complain about the use of your personal information, then you should contact the Information Commissioner’s Office:
Information Commissioner’s Office
Cheshire SK9 5AF
Helpline number: 0303 123 1113