CommunicationShAPENCT06035640
Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences
An observational study of Communication, run by East Kent Hospitals University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
1 in 7 infants born in the United Kingdom will require treatment on a Neonatal unit to treat conditions, which vary in there level of severity. Treatments and interventions aimed at supporting the unwell neonate have associated risks and the evidence underpinning them can range from limited to substantial. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Communication
- What is being tested?
- Interview
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Dec 2022to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will recruit parents of infants who have received care on a Neonatal Unit within the past 2years. Given the nature of interventions being studied, these are most likely to be (but not limited to) premature infants.
Who may be able to join
- Parent of an Infant who, whilst on a neonatal unit, has received either; a transfusion of blood products, pharmacotherapy for persistent ductus arteriosus or corticosteroid therapy for chronic lung disease
Who cannot join
- The infant must have received the above treatments within the last 6 months prior to interview AND have been discharged from neonatal care for at least 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences (The ShAPE Study)
1 in 7 infants born in the United Kingdom will require treatment on a Neonatal unit to treat conditions, which vary in there level of severity. Treatments and interventions aimed at supporting the unwell neonate have associated risks and the evidence underpinning them can range from limited to substantial. There is a degree of uncertainty in Neonatology, which can be very stressful for parents and clinicians alike. Parents need to be supported by the clinical team in making many complicated clinical decisions, a skill that requires robust communication of risks, benefits and alternatives.
In 2019 the British Association of Perinatal Medicine released a framework of care advocating Shared Decision Making (SDM) as the optimal process for making clinical decisions on neonatal units. This model builds upon the "informed decision" models by putting a greater emphasis on involving parents in key decisions regarding the treatment of their babies medical condition. Evidence has demonstrated that SDM can improve parental satisfaction and reduce anxiety and the likelihood of feeling regret.
Read more
In order to support parents in the SDM process, clinicians need to be able to provide impartial information encompassing the proposed intervention, intended benefit, potential risks and alternatives. Whilst clinicians may have preconceptions on the information that they think should be provided, there is limited evidence in the literature of what are the most important concepts and themes that parents would expect to be conveyed during the SDM process.
ShAPE is a qualitative study that aims to
- Conditions
- Communication
- Being tested
- Interview
- Keywords
- Neonatal Care, Shared Decision Making
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Participants will be engaged in a semi-structured interview.
What is being measured
The primary outcome is the main question the study is designed to answer.
What are the main communicative, environmental and informative factors that support the facilitation of effective shared decision making on the neonatal unit? We aim to identify common themes that highlight aspects of the decision making process.
We aim to identify common themes that highlight aspects of the decision making process, which are the most important to parents.
Measured: Interviews will focus on encounters with clinical staff, whilst their infant was an inpatient on a Neonatal Unit. Interviews will be performed over the 1year period of the recruitment window.
Secondary outcomes (1)
How does the quality of the shared decision process, experienced by parents on neonatal units in the UK, impact their level of satisfaction with the care their infant received?
We aim to identify common themes that highlight aspects of the decision making process, which influence parent satisfaction with the care received by their infant.
Measured: Interviews will focus on encounters with clinical staff, whilst their infant was an inpatient on a Neonatal Unit. Interviews will be performed over the 1year period of the recruitment window.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start19 Dec 2022
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Kent Hospitals University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035640
- Sponsor's protocol ID
- 2022/CTU2/NEONAT
- Acronym
- ShAPE
- Status last verified
- May 2026
- First submitted
- 15 Feb 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Shared Decision Making on the Neonatal Unit Through Assessment of Parental Experiences (The ShAPE Study)
- ClinicalTrials.gov ID
- NCT06035640
- Acronym / sponsor ID
- ShAPE / 2022/CTU2/NEONAT
- Conditions
- Communication
- Keywords
- Neonatal Care, Shared Decision Making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- East Kent Hospitals University NHS Foundation TrustOther government
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 13 Sep 2023 (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.
1 in 7 infants born in the United Kingdom will require treatment on a Neonatal unit to treat conditions, which vary in there level of severity. Treatments and interventions aimed at supporting the unwell neonate have associated risks and the evidence underpinning them can range from limited to substantial. There is a degree of uncertainty in Neonatology, which can be very stressful for parents and clinicians alike. Parents need to be supported by the clinical team in making many complicated clinical decisions, a skill that requires robust communication of risks, benefits and alternatives.
In 2019 the British Association of Perinatal Medicine released a framework of care advocating Shared Decision Making (SDM) as the optimal process for making clinical decisions on neonatal units. This model builds upon the "informed decision" models by putting a greater emphasis on involving parents in key decisions regarding the treatment of their babies medical condition. Evidence has demonstrated that SDM can improve parental satisfaction and reduce anxiety and the likelihood of feeling regret.
In order to support parents in the SDM process, clinicians need to be able to provide impartial information encompassing the proposed intervention, intended benefit, potential risks and alternatives. Whilst clinicians may have preconceptions on the information that they think should be provided, there is limited evidence in the literature of what are the most important concepts and themes that parents would expect to be conveyed during the SDM process.
ShAPE is a qualitative study that aims to
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will recruit parents of infants who have received care on a Neonatal Unit within the past 2years. Given the nature of interventions being studied, these are most likely to be (but not limited to) premature infants.
Key inclusion criteria (1 listed)
- Parent of an Infant who, whilst on a neonatal unit, has received either; a transfusion of blood products, pharmacotherapy for persistent ductus arteriosus or corticosteroid therapy for chronic lung disease
Key exclusion criteria (1 listed)
- The infant must have received the above treatments within the last 6 months prior to interview AND have been discharged from neonatal care for at least 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewParticipants will be engaged in a semi-structured interview. | Other | – |
Primary outcome
What are the main communicative, environmental and informative factors that support the facilitation of effective shared decision making on the neonatal unit? We aim to identify common themes that highlight aspects of the decision making process.
Time frame: Interviews will focus on encounters with clinical staff, whilst their infant was an inpatient on a Neonatal Unit. Interviews will be performed over the 1year period of the recruitment window.
We aim to identify common themes that highlight aspects of the decision making process, which are the most important to parents.
1 secondary outcome
How does the quality of the shared decision process, experienced by parents on neonatal units in the UK, impact their level of satisfaction with the care their infant received?
Time frame: Interviews will focus on encounters with clinical staff, whilst their infant was an inpatient on a Neonatal Unit. Interviews will be performed over the 1year period of the recruitment window.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Communication, run by East Kent Hospitals University NHS Foundation Trust at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
What are the main communicative, environmental and informative factors that support the facilitation of effective shared decision making on the neonatal unit? We aim to identify common themes that highlight aspects of the decision making process. (time frame: Interviews will focus on encounters with clinical staff, whilst their infant was an inpatient on a Neonatal Unit. Interviews will be performed over the 1year period of the recruitment window.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.