Preterm InfantsNEWTS HAPI-1NCT07650045
Neonatal Wireless Transmission System: Hospital Adoption and Planning for Implementation Study
An observational study of Preterm Infants and Vital Sign Monitoring, run by Cambridge University Hospitals NHS Foundation Trust.
Trial summary
To explore the feasibility, acceptability, and implementation considerations associated with the adoption of the NeWTS system within NHS neonatal services. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants, Vital Sign Monitoring
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: staff with experience of working or supporting NICU care
Who may be able to join
- staff with experience of working or supporting NICU care Informed consent
Who cannot join
- no informed consent
About this study
To explore the feasibility, acceptability, and implementation considerations associated with the adoption of the NeWTS system within NHS neonatal services.
Read the detailed description
Visits to a range of NICUs across the UK to engage staff and explore the feasibility, acceptability, and implementation considerations associated with the adoption of the NeWTS system within NHS neonatal services.
- Conditions
- Preterm Infants, Vital Sign Monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Thematic analyses of staff views
thematic analyses of staff views on the NEWTS system
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Beardsall, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650045
- Sponsor's protocol ID
- A097788
- Acronym
- NEWTS HAPI-1
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data is recordings from staff within the neonatal unit and we wish to maintain confidentiality of all staff
Publications
Bonner O, Beardsall K, Crilly N, Lasenby J. 'There were more wires than him': the potential for wireless patient monitoring in neonatal intensive care. BMJ Innov. 2017;3(1):12-18. 2. Boundy EO, Dastjerdi R, Spiegelman D, Fawzi WW, Missmer SA, Lieberman E, et al. Kangaroo mother care and neonatal outcomes: a meta-analysis. Pediatrics. 2016;137(1):e20152238. 3. Conde-Agudelo A, Díaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2016;(8):CD002771. 4. WHO Immediate KMC Study Group. Immediate "kangaroo mother care" and survival of infants with low birth weight. N Engl J Med. 2021;384(21):2028-2038. 5. Greenhalgh T, Wherton J, Papoutsi C, Lynch J, Hughes G, A'Court C, et al. Beyond adoption: a new framework for theorising and evaluating non-adoption, abandonment, and challenges to the scale-up, spread, and sustainability of health and care technologies. J Med Internet Res. 2017;19(11):e367. 6. International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals: defining the role of authors and contributors. ICMJE; 2024 [cited 2026 Jun 10]. Available from: https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Wireless Transmission System: Hospital Adoption and Planning for Implementation Study
- ClinicalTrials.gov ID
- NCT07650045
- Acronym / sponsor ID
- NEWTS HAPI-1 / A097788
- Conditions
- Preterm Infants, Vital Sign Monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the feasibility, acceptability, and implementation considerations associated with the adoption of the NeWTS system within NHS neonatal services.
Detailed description
Visits to a range of NICUs across the UK to engage staff and explore the feasibility, acceptability, and implementation considerations associated with the adoption of the NeWTS system within NHS neonatal services.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- staff with experience of working or supporting NICU care
Key inclusion criteria (1 listed)
- staff with experience of working or supporting NICU care Informed consent
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thematic analyses of staff views
Time frame: 1-2 hours
thematic analyses of staff views on the NEWTS system
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- BackgroundBonner O, Beardsall K, Crilly N, Lasenby J. 'There were more wires than him': the potential for wireless patient monitoring in neonatal intensive care. BMJ Innov. 2017;3(1):12-18. 2. Boundy EO, Dastjerdi R, Spiegelman D, Fawzi WW, Missmer SA, Lieberman E, et al. Kangaroo mother care and neonatal outcomes: a meta-analysis. Pediatrics. 2016;137(1):e20152238. 3. Conde-Agudelo A, Díaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2016;(8):CD002771. 4. WHO Immediate KMC Study Group. Immediate "kangaroo mother care" and survival of infants with low birth weight. N Engl J Med. 2021;384(21):2028-2038. 5. Greenhalgh T, Wherton J, Papoutsi C, Lynch J, Hughes G, A'Court C, et al. Beyond adoption: a new framework for theorising and evaluating non-adoption, abandonment, and challenges to the scale-up, spread, and sustainability of health and care technologies. J Med Internet Res. 2017;19(11):e367. 6. International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals: defining the role of authors and contributors. ICMJE; 2024 [cited 2026 Jun 10]. Available from: https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
- Individual participant dataSharing planned: Undecided. The data is recordings from staff within the neonatal unit and we wish to maintain confidentiality of all staff
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infants and Vital Sign Monitoring, run by Cambridge University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thematic analyses of staff views (time frame: 1-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07650045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.