RecruitingObservational

The babies’ longitudinal outcomes, ‘omics, and milestones study

The BLOOMS study aims to understand the long-term health and development of babies who receive care in a neonatal intensive care unit (NICU). We know some babies face challenges later on, and this research wants to discover how to give them the best early support. The study hopes to improve how we use genetic information for earlier diagnoses, find warning signs for childhood problems, and understand what causes these issues. Families with babies in NICUs in Cambridge, Luton, or Norwich for at least 48 hours are invited to take part. It involves giving blood and poo samples, answering questionnaires, and developmental assessments over several years. The goal is to help future families and children.

At a glance

Status

Recruiting

Enrolment target

3,225

Start

01 Jan 2026

Estimated completion

01 Jan 2028

Babies currently admitted to the tertiary NICU for at least 48 hours

What is this study about?

The 'BLOOMS' study is all about understanding how babies who need special hospital care, sometimes called neonatal care, grow and develop over time. We know that some of these babies might face challenges with their health, learning, or overall development as they get older. This study is designed to help us understand why these challenges happen and, most importantly, how we can give children the best possible support from an early age.

Our main goals are to get better at spotting potential health problems early on, often by looking at information from a baby's genes alongside other health details. We also want to find 'early warning signs' that could help doctors and teachers provide support before any problems become serious. By understanding what causes these health and developmental issues, we can work towards improving things for young children in the future.

This research is really important because it could lead to new ways of helping children who have started their lives needing specialist care. By taking part, families are helping doctors and researchers learn valuable information that could make a big difference to many children's lives in the years to come.

Key takeaways

Aims to improve support for babies who need specialist hospital care.
Focuses on early diagnosis and spotting developmental challenges quickly.
Involves blood/poo samples and developmental check-ups over 5 years.
Takes place for families with babies in specific NICUs (Cambridge, Luton, Norwich).
Helps advance understanding of children's health, no direct treatment for your baby.
Your child will receive birthday presents each year for participating.

Who may be eligible?

We're looking for families whose baby is currently in a specialist baby unit (NICU) in Cambridge, Luton, or Norwich. Your baby needs to have been in the NICU for at least 48 hours to be considered for the study. Also, an adult who is legally responsible for the baby must be available and willing to agree for them to take part.

Parents who want to take part must be 18 years or older and be able to understand and agree to the study in English. If there isn't an adult legally responsible for the baby who can give consent in English, then the baby won't be able to join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my baby currently in a specialist baby unit (NICU) in Cambridge, Luton, or Norwich?
Has my baby been in the NICU for at least 48 hours?
Am I an adult (18 or over) who is legally responsible for the baby?
Can I understand and agree to take part in the study in English?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be asked to read and sign a consent form for yourself and your baby. We'll ask for your and your baby’s name, date of birth, NHS number, and contact details so we can keep in touch. You'll also fill out some online questionnaires about your family's health and background.

Soon after joining, a small blood sample will be taken from your baby. Your baby will have another small blood sample and a poo sample collected from their nappy before they leave the NICU. We'll also ask for a blood sample from any parent who is happy to give one. After your baby goes home, we'll contact you when they are 9 months old, then again at 2, 4, and 5 years old. At these times, you'll complete questionnaires and do some simple developmental checks with your baby at home.

When your baby is 3 years old, we'll invite you to visit Cambridge for a day. During this visit, your baby will have a full check-up of their development, their height and weight will be measured, and they'll have a painless test called an EEG, which looks at brain activity. Another small blood sample and a poo sample will also be collected. We'll also ask for permission to look at your baby's health and education records until they turn 16, and at health records for parents who were pregnant, from before birth up to one year after birth. Your active involvement in the study is for 5 years, but we will continue to access records until your child is 16.

Potential risks and benefits

Taking part in this study could potentially give the medical team caring for your child extra information that might be helpful. Your child's involvement is vital for the study's success, and they will receive birthday presents from the study team each year. The main benefit of participating is helping us learn more to improve the care and support for other families and babies in the future. There are no known risks to your baby or to you as parents. While blood sampling can be a bit uncomfortable, it will always be done by trained staff who will make it as easy as possible. You are free to withdraw from the study at any time without affecting your child's medical care.

Locations (3)

Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England
Norfolk and Norwich University Hospitals NHS Foundation Trust
City only
Norwich, England
Luton and Dunstable University Hospital
Approximate
Luton, England

Common questions

What is a 'NICU'?

A NICU stands for Neonatal Intensive Care Unit. It's a special hospital ward where newborn babies who need extra medical care are looked after.

Will my baby get any special treatment in the NICU if we join?

No, your baby will continue to receive the best standard care in the NICU, just like any other baby. The study is about collecting information, not changing their routine medical treatment.

How long will I be involved in the study?

Your active involvement with questionnaires and visits will be for 5 years, until your child is 5 years old. The study will continue to look at health and education records until your child is 16.

Do I have to provide a blood sample?

We will ask parents who are happy to take part to provide a blood sample, but it's completely optional for parents. Your baby will have blood samples as part of the study.

What happens to the information collected?

All information collected will be kept private and stored securely. It will be used by the research team to understand more about babies' health and development over time to help future children.

How to find out more

Heather Pierce

hhp24@cam.ac.uk +44 (0)1223769096 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.