What is the study about?

Fifteen million babies are born too soon every year around the world. One million of these babies die before their 5th birthday because of their prematurity, many in Africa. In Kenya, 20 babies in every 1000 will die in the first month of life. Many premature babies develop hypothermia (temperature <36.5c) which is strongly linked to death in the first month of life. For every 1 degree drop in temperature, the baby's risk of death is increased by 80%. There are lots of actions that can be taken to keep babies' temperatures normal, but in labour wards in Kenyan hospitals, the mothers' needs often take priority. Simple tools are needed to help labour ward staff keep babies' temperatures normal including what actions to take if their temperature drops.

For the last 5 years our team has been investigating using a simple paper form, called an early warning score (EWS). Babies' temperatures are noted on a red, amber or green part of the form, depending on the value, alerting staff to babies who are sicker and need extra help. Our work has showed it is feasible to complete the EWS in the newborn unit. We also talked to health workers and mothers to learn what changes are needed to make the EWS better. In our previous NEWS-K study (https://pubmed.ncbi.nlm.nih.gov/38734617/), we studied what happened to 465 babies in 3 hospitals in Kenya. 1 in 3 of all babies had moderate hypothermia when admitted for newborn care and tragically 1 in 4 of all babies died.

In this study, we will focus on keeping babies warm in the labour ward before they are admitted to the newborn unit or postnatal ward. Labour ward staff will be asked to use the EWS, and we will give them a plan of actions (called the 'NEWS-HEAT care bundle') to use if babies' temperatures become abnormal. The NEWS-HEAT care bundle brings together the EWS and actions that are already known to improve temperatures, e.g., wrapping babies in plastic wraps and using a warmer.

Parents will be informed about the study at all hospitals via posters and other communications in the labour ward and antenatal clinics. To make sure NEWS-HEAT is being used as expected, we will observe care in a sample of hospitals, on days/nights when labour ward is busy and quiet. We will conduct focus groups with health workers in the labour ward to understand what did and didn't work well. 

If the NEWS-HEAT care bundle is shown to improve babies' temperatures, we will work with policy-makers to help to implement it widely across other hospitals. We will share our results widely at conferences in Kenya and the UK, high impact scientific journal and with all stakeholders involved. We will also conduct activities to help strengthen research capacity in Kenya, including training in qualitative research methods and clinical trials.

Who can take part in the study?

Eligible babies born at participating hospitals in Kenya.

What is being tested in the study?

We will test if the NEWS-HEAT care bundle reduces the number of babies who are cold.

What is this being compared to?

Standard care, or 'early essential newborn care'.

What are we trying to find out?

We will compare the number of babies with hypothermia at the time of admission of the newborn unit or postnatal ward at the hospitals who did or didn't use the NEWS-HEAT care bundle, to see if it reduces the number of babies with hypothermia.

How many patients do we need?

We expect to include around 12,000 babies in total, across 3 phases of the study, over 8 months in total.

Funder

UK Research and Innovation