Helping to Improve Newborn Screening for Congenital Heart Disease (CHD)

We are inviting parents and legal guardians to consider whether their baby may take part in a research study after birth. This information sheet explains what taking part would involve, so that you can decide whether you would like your baby to take part.

No. Taking part is voluntary. You also do not need to decide immediately.

You are receiving this information during pregnancy so that you have time to read it, think about the study and ask questions before your baby is born. You can ask questions, take time to decide or choose not to take part. Your decision will not affect your baby’s care, your care or your relationship with NHS staff.

If you decide that you would like your baby to take part, written consent must be received before any study recording or other study procedure is carried out. No research data will be collected before consent, and retrospective or deferred consent will not be used.

After your baby is born, the study team will confirm that your baby is still eligible, that the recording is clinically appropriate and that you are still happy for your baby to take part.

Please tell the study team if you need this information in another format, language support or help to understand it.

Around 6,000 babies are born each year in the UK with congenital heart disease (CHD), meaning a problem with how the heart works. Finding CHD early helps babies receive care quickly. Current checks include the pregnancy ultrasound scan, the newborn examination and pulse oximetry, but some babies with CHD are still missed.

A pulse oximeter is a small sensor that shines red and infrared light through the skin to measure oxygen levels and pulse rate. Pulse oximetry screening is routinely used for newborn babies in many countries around the world. It can help identify some babies with serious congenital heart disease (CHD), but it does not detect every case. 

We want to improve the pick-up of CHD by first finding out whether it is feasible and acceptable to use two pulse oximeters at the same time—one on the right hand or wrist and one on either foot—and measure the oxygen levels and record information from the pulse signals using a mobile app.

The app is for research data collection only. It does not diagnose a condition, give a screening result or alert, recommend treatment, replace usual newborn screening or change your baby’s care.

This feasibility study will help us decide whether the procedures are practical and acceptable and whether the recordings provide useful information for planning a larger study. At this stage it is not designed to determine how accurately the method detects CHD or whether it improves clinical outcomes.

Up to 120 babies will take part in one of three groups:

• 80 healthy term newborn babies having their routine newborn check;
• 20 term newborn babies with suspected or confirmed CHD; and
• 20 preterm babies with a patent ductus arteriosus (PDA) who are already due to receive medication treatment as part of their usual care.

The study team will confirm your baby’s group, eligibility and clinical suitability. Your baby will not take part if they are too unwell, urgent care needs to take priority, or suitable sensor sites are not available because of skin problems, dressings, lines or other equipment.

Written consent must be received from a parent or other person aged 16 years or over with parental responsibility. If a parent is under 16, or a person with parental responsibility is unable to make this decision at the time, consent will not be sought from them. Another person aged 16 years or over with parental responsibility may be approached if available; otherwise, the baby cannot take part.

For healthy term babies, the study recording will usually be incorporated into the local newborn pulse oximetry screening pathway. For term babies with suspected or confirmed congenital heart disease, the first recording may take place during the relevant routine screening or clinical care pathway. In both groups, the usual oxygen-level and pulse-rate readings will be viewed directly on the pulse oximeters and managed as part of usual care. The research component is that information from two pulse oximeters will be transmitted simultaneously to the app and recorded for about five minutes.

The process will be:

A trained member of the clinical or research team will place one soft sensor on your baby’s right hand or wrist and another on either foot. 

The two pulse oximeters will connect wirelessly to a research app on a password-protected study device. 

Once stable signals are visible, information from both sensors will be recorded simultaneously for about five minutes. 

Your baby’s clinical care will always take priority. The recording may be delayed or stopped if your baby is unsettled or needs care. 

If your baby takes part, they will follow one of the three study pathways described below. The pathway will depend on which group applies to your baby, as determined by the clinical and research teams.

Healthy term newborn babies:

If your baby is a healthy term newborn, the study recording will usually be carried out during or around the routine newborn check, typically around 4–8 hours after birth where clinically and practically appropriate. This is expected to involve one 5-minute recording.

Babies with suspected or confirmed congenital heart disease:

If your baby has suspected or confirmed congenital heart disease, the first study recording may take place during the relevant newborn or follow-up clinical pathway. A repeat recording may be requested later, for example after 24 hours of age or around a routine one-month follow-up appointment, if clinically and practically appropriate.

Preterm babies with patent ductus arteriosus:

If your baby is preterm and has patent ductus arteriosus, also called PDA, the study may involve a recording before and after clinically indicated medication treatment for PDA. The decision to treat PDA, the choice of medication and the timing of treatment will be made entirely by your baby’s clinical team as part of usual care. The study will not influence those decisions.

The repeat recording for babies with suspected or confirmed congenital heart disease, and both planned recordings for babies with PDA, are covered by the initial written consent. However, a planned recording may not take place if your baby is clinically unsuitable, you decide not to proceed at that time, the timing of treatment or follow-up does not allow it, or practical circumstances make it impossible. Your baby’s clinical care will always take priority and will not be delayed or changed to obtain a study recording.

The study will collect only the information needed to answer the research questions:

• The two pulse oximetry signals, including oxygen level, pulse rate, pulse wave and signal-quality information;
• Whether the 5-minute recording was complete, and any movement, interruption or technical problem;
• Your baby’s sleep or behavioural state and feeding;
• A skin-tone assessment beside each sensor site; and
• Relevant information from your baby’s medical record: gestational and postnatal age, sex, ethnicity, birthweight, mode of birth, home postcode (used to calculate an area-level deprivation score), clinical group or diagnosis, respiratory support, relevant treatment and heart-scan information where applicable.

The app will use a unique study ID and recording number. Your baby’s name, date of birth, address, NHS number and hospital number will not be entered into the app or exported physiological data file.

Two trained members of the study team will independently compare uncompressed skin beside each sensor site with a six-tone shade card and record the closest matching shade for each site: the right forearm just above the hand/wrist sensor and the lower leg just above the foot sensor. If a site cannot be assessed because of equipment, dressings or skin concerns, an alternative site on the upper arm or upper chest may be used and recorded.

This is not a medical test and will not affect your baby’s care. It is included because pulse oximeter performance may differ across skin tones, and future newborn screening should work well for all babies.

If your baby is unsettled, feeding or receiving care, the recording may be delayed, stopped, repeated where appropriate or recorded as incomplete. Clinical care always comes first.

The app does not provide clinical alerts. If staff see an unexpectedly low oxygen level or unusual pulse rate displayed directly on either pulse oximeter, or notice any change in your baby’s condition, they will follow normal clinical assessment and escalation procedures. Any repeat observations or heart scan would be part of usual care and decided by the clinical team.

There may be no direct benefit to you or your baby. Taking part may help researchers decide whether this approach is feasible and acceptable and should be tested in a larger future study.

The study is low risk. Possible short-lived burdens include:

• Brief discomfort, crying or unsettled behaviour;
• Temporary mild marking where a sensor was placed;
• A short additional time during routine care; or
• Anxiety when discussing newborn heart screening, CHD or PDA.

Soft newborn sensors will be used by trained staff, and the procedure will stop if there is a concern or your baby needs care. The sensors are the same type as those used in standard care, but the research recording and any repeat recordings may involve some additional time or handling.

There is no payment or voucher for your baby taking part in the recording. One parent or other person aged 16 years or over with parental responsibility may also be invited to complete a short questionnaire, and some may be invited to a separate optional interview. You will receive separate information and provide separate consent. A £25 non-cash voucher will be offered only for the optional interview, not for the recording or questionnaire.

Yes. You may withdraw your baby at any time without giving a reason and without affecting care. No further study procedures or data collection will take place after withdrawal.

If analysis has not started, you may ask us to delete data already collected. Once data have been fully anonymised, or pseudonymised and included in the analysis dataset after analysis has started, they may need to be retained to protect the reliability of the research.

Results may appear in reports to the funder, academic publications, conference presentations, policy briefings and plain-language summaries. You and your baby will not be identified in any report or publication.

The study is planned to run from 1 July 2026 to 30 June 2028. The consent form will ask whether you would like to receive a plain-language summary after the study has ended and the results have been analysed. If you choose yes, your contact details will be kept and used for this purpose. The summary will also be made available through appropriate study and public-partner channels.

The National Institute for Health and Care Research (NIHR) Research for Patient Benefit Programme funds the study. University Hospitals Sussex NHS Foundation Trust is the Sponsor and has overall responsibility for it.

The study team includes University Hospitals Sussex NHS Foundation Trust, Brighton and Sussex Medical School, Kingston University, the University of Brighton and public contributors. The app was developed at Kingston University, which owns the related intellectual property. These interests have been declared to the Sponsor and are managed under Sponsor procedures.

We will need to use information from you and from your baby’s medical records for this research project.

This information will include your name and contact details and your baby’s name or initials, date of birth, NHS or hospital number, home postcode and relevant medical information. People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you or your baby are will not be able to see your names or contact details. Your data will have a code number instead.

University Hospitals Sussex NHS Foundation Trust is the sponsor of this research and is responsible for looking after your information. We will share your information related to this research project with the following types of organisations:

• Approved UK academic collaborators, including Kingston University and the University of Brighton, who will normally receive coded information only; and
• Authorised Sponsor representatives, auditors, regulators, the Health Research Authority or the Research Ethics Committee where they need to check that the study is being conducted properly.

We will keep all information about you safe and secure by:

• Using a study code instead of names in research datasets;
• Keeping names, contact details and the secure linkage file separately on approved access-controlled systems;
• Limiting access to authorised people who need the information for the study; and
• Using approved encrypted methods to transfer coded data.

Your data will not be shared outside the UK.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

We will keep your study data for five years after the study has ended. The study data will then be fully anonymised and securely archived or destroyed.

Fully anonymised research data and non-identifiable documentation may be kept for up to 20 years for future ethically approved scientific research, but only if this is consistent with your consent and approved by the Sponsor and Data Protection Officer. Identifiable or linkable data will not be made public.

You can withdraw your baby from the study at any time, without giving a reason. We will usually keep information already collected, but if analysis has not started, you may ask us to delete data collected for this study. 

You may ask to access, correct or delete personal information we hold about you or your baby, or object to how it is used. These rights may be limited if fulfilling your request would prevent or seriously impair the research. If we cannot fulfil your request, we will explain why.

You can find out more about how we use your information:

• By contacting the Information Commissioner’s Office at ico.org.uk/make-a-complaint or 0303 123 1113.
• In the Health Research Authority leaflet at www.hra.nhs.uk/patientdataandresearch;
• By asking one of the research team;
• By emailing the Sponsor Data Protection Officer/Information Governance team at uhsussex.informationgovernance@nhs.net; or
• By contacting the Information Commissioner’s Office at ico.org.uk/make-a-complaint or 0303 123 1113.

Approved collaborators may analyse coded physiological recordings and the minimum relevant clinical information using study IDs only. They will not receive names, NHS or hospital numbers or the secure linkage file.

Only fully anonymised data may be considered for an approved research repository or future research. Pseudonymised linked datasets containing demographic, clinical, skin-tone or physiological data will not be made publicly available.

Please contact the study team or Sponsor/R&D representative below. NHS indemnity arrangements cover negligent harm arising from study procedures carried out by NHS staff on NHS premises. The NHS does not provide no-fault compensation for harm not caused by negligence.

For concerns about care or the way you have been treated, you may contact the Patient Advice and Liaison Service (PALS). For concerns about use of personal data, contact the Sponsor Data Protection Officer or the Information Commissioner’s Office.

All research in the NHS is reviewed before it begins. This study will not start until it has received a favourable opinion from a Research Ethics Committee, Health Research Authority approval and University Hospitals Sussex NHS Foundation Trust sponsor approval.

Research Ethics Committee: [insert name after review]. REC reference: [insert]. HRA approval date: [insert].

If you would like your baby to take part or want more information, speak to the person who gave you this sheet or contact the study team. If you decide to take part, the team will confirm that your baby is eligible and clinically suitable, receive written consent and arrange the study recording if it is clinically and practically appropriate.

If you decide not to take part, your baby’s care will not be affected.

Chief Investigator:
Dr Ramon Fernandez
Brighton and Sussex Medical School
Email: ramon.fernandez@nhs.net

Sponsor / R&D contact:
Scott Harfield
University Hospitals Sussex NHS Foundation Trust
Email: scott.harfield@nhs.net

Sponsor Data Protection Officer / Information Governance team:
uhsussex.informationgovernance@nhs.net

Information Commissioner’s Office:
ico.org.uk/make-a-complaint
Telephone: 0303 123 1113

Patient Advice and Liaison Service (PALS), Royal Sussex County Hospital:
Telephone: 01273 664511 or 01273 664973
Email: uhsussex.pals@nhs.net