About your baby

• Your baby was born early or small, which means they can get cold very easily.
• Keeping them warm is very important, especially right after birth and in the first few days.

About the NEWS-HEAT study

• Your hospital is taking part in a study called NEWS-HEAT which stands for Neonatal Early Warning Score - Hypothermia Evaluation and Treatment.
• The study looks at how hospitals keep small or early born babies warm after birth.
• 28 hospitals across Kenya are taking part in this study.
• The study is led by the Universities of Nairobi and Nottingham (UK), in collaborations with the Kenya Paediatric Research Consortium, Aga Khan University and supported by the Preemie Love Foundation.

What the study is doing

• For the first part of the study, nurses and midwives will continue caring for babies as they normally do.
• Staff in the labour ward will then receive training on Early Essential Newborn Care (EENC), which includes simple ways to keep babies warm, such as skin-to-skin contact and wrapping the baby well.
• All hospitals will then implement EENC as standard care.

Next phase of the study

• Half of the hospitals will also use an extra “NEWS-HEAT care bundle” which is aimed at keeping babies warm.
• This includes checking the baby’s temperature soon after birth and again before leaving the labour ward or theatre, and when admitted to the newborn or postnatal ward.
• If a baby is cold, staff will take extra steps to warm them.

What information is collected

• Nurses and midwives will note down your baby’s temperature at key times.
• They will collect information on your baby from hospital and study records up until the baby goes home or is a week old (whichever is sooner).
• They will also note basic details such as your age, pregnancy history, your baby’s weight, and how early they were born.
• Your personal details like your contact information included.
• All information is stored safely using an ID number instead of your name.

Follow‑up after birth

• We want to check how your baby is doing because early or small babies can face more challenges in their first week.
• If you have gone home, a research nurse will call you.
• If you are still in hospital, the nurse will use information in the hospital records to find out how your baby is doing.

Study organisers and funding

• The study is being organised by the University of Nottingham, UK in collaboration with Kenya Paediatric Research Consortium (Keprecon).
• The funding for the study is provided by the Medical Research Council (MRC), which is part of UK Research and Innovation (UKRI).

Ethical approvals

We have obtained the necessary approvals to conduct this study from:

• The University of Nottingham, UK
• Kenyatta National Hospital and the University of Nairobi
• Moi Teaching and Referral Hospital
• National Commission for Science Technology and Innovation (NACOSTI)
• The County Governments for all counties involved in the research
• All participating hospitals

Data collection and management

• We will collect data on babies seven days after birth. Some maternal information will also be collected from clinical records and additional trial forms.
• Research nurses will record data on paper and enter it into a secure database.
• All data is stored in compliance with Good clinical practice (GCP) and General Data Protection Regulation (GDPR), ensuring encryption, restricted access, and anonymisation. 

Consent to participate

• In this study, we are not changing the standard practice within the hospital.
• All eligible babies born in the hospital during the study period will be cared for in line with the study, which focuses on using methods already known to help keep babies born.
• We will not ask parents for their explicit consent to keep their baby warm because this will be provided as standard of care.
• The NEWS-HEAT trial uses a ‘no consent’ model in line with OTTAWA recommendations for cluster trial.
• No identifiable data (like yours and your baby’s name or contact details) will leave the hospital. We will use something called ‘pseudo-anonymisation’ and all babies and mums will be identified using an ID number.
• If a baby leaves hospital before they are a week old, a research nurse will ask parents for their permission to telephone them on day eight to find out how their baby is doing.
• They will be asked to sign a form to confirm they have given their permission.

Contact the team

You can email the central trial team at newsheat@nottingham.ac.uk. This inbox is monitored by members of the NEWS-HEAT team based in both the UK and Kenya.

Parents are encouraged to speak directly with the nurses and doctors in the labour suite and on the wards if they have any questions or concerns during their stay.

See all the hospitals taking part in this study

Data Protection at the Nottingham Clinical Trials Unit 

The Nottingham Clinical Trials Unit (NCTU) at the University of Nottingham, has an obligation to the individuals about whom it holds data, to control and process the information in a manner that is compliant with the provisions of Data Protection legislation.

All data collected, stored and processed as part of a research study coordinated by NCTU, will be bound by privacy policies specific to each study sponsor. The sponsor is an individual, company, institution or organisation that takes responsibility for the initiation, management and/or financing of a study. Each individual sponsor decides what information will be collected for the study and how it will be used. Under the General Data Protection Regulation (GDPR), the Data Controller for each study is the sponsoring organisation.

Information about the way your data is collected, stored, shared and archived is described in a privacy notice. The privacy notice for the study is detailed within individual study participant information sheets which are issued prior to consent. These privacy notices can also be accessed on the University of Nottingham website.

If you wish to raise a complaint on how your personal data has been handled or would like further details on how the University of Nottingham processes your data, you can contact the University of Nottingham Data Protection Office by emailing data-protection@nottingham.ac.uk.