Periviable InfantsALLIANCENCT05265195
PeriviAble DeLiveries: ALIgning PArental aNd PhysiCian PrioritiEs (ALLIANCE)
An observational study of Periviable Infants and Extreme Prematurity, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Background: There is significant variation in how clinicians currently present information to parents in periviable labour. Whilst each conversation with an individual set of parents will vary, the current level of variation is extreme. Read more about this study
- Who is it for?
- Ages 22 to 24 weeks
- Conditions the study is for
- Periviable Infants, Extreme Prematurity, Communication
- What is being tested?
- Mixed Methods study
- How many people
- 340 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2022to 30 Jan 2025
- 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 22 to 24 weeks
- All sexes
- No healthy volunteers
- Child
Study population: This study will recruit a mixture of participants at various stages of the study: * Parents who have experienced a periviable labour, * Clinicians (Obstetricians, Midwives and Neonatologists) with experience of managing periviable deliveries.
Who may be able to join
- Infants born at periviable gestation. For this study periviability is defined as 22+0 - 24+6 weeks gestation.
Who cannot join
- Infants <22+0 or >24+6 weeks gestation.
- Specific inclusion and exclusion criteria apply to each phase of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Jennifer Peterson, jennifer.peterson@mft.nhs.uk
Ajit Mahaveer, ajit.mahaveer@mft.nhs.uk
About this study
Background:
There is significant variation in how clinicians currently present information to parents in periviable labour. Whilst each conversation with an individual set of parents will vary, the current level of variation is extreme. In collaborative discussions with the neonatal parental advisory group whilst designing this project, parents reported numerous experiences of significant variation in practice between clinicians in relation to periviable delivery management. There is a pressing issue of injustice here as the hospital or clinician the parent presents to in labour should not restrict their access to information and options for management at delivery.
Read more
Parents should be empowered and engaged in making an individualised decision for their infant. However, this is not possible if information is not accurately presented to them. There is a gap in knowledge about what information is vital to include in periviable decision-making conversations between parents and healthcare professionals. This study aims to address this important gap in knowledge.
Research Question: How can information sharing and decision-making conversations between healthcare professionals and parents prior to periviable birth be improved?
Research Aims:
- To gain understanding of current UK-wide antenatal optimisation practices for infants born at periviable gestations.
- To establish an evidence-based conversational structure for pre-delivery periviable decision-making discussions, and a prioritised set of key discussion topics derived from parental consensus and clinician input.
- To develop a set of parent and clinician derived recommendations to improve pre-delivery periviable decision-making conversations.
Methodology:
The study would progress along the following structure:
- Literature Review of literature related to how and what information is presented to parents facing periviable labour by healthcare professionals.
- Semi-structured interviews with clinicians and parents. The aim will be to determine an evidence-based set of priorities for each group and identify the differences in priorities and barriers that exist in communication between parents and clinicians.
- National Evaluation of current periviable management practices across the UK. This will benchmark and expose variation in current practice.
- Analysis of pre-delivery periviable conversations.
- Focus groups with parents and clinicians to consolidate and stratify key priority themes for periviable decision-making conversations and assess acceptability of developing parent-centred periviable delivery resources.
- Parent survey of parent-assessed long-term outcomes for periviable delivery survivors.
Impact and Dissemination:
This study will investigate the key topic areas and conversational structure of pre-delivery periviable decision-making conversations, aiming to provide evidence-based recommendations for improvement.
Read the detailed description
Research Aims:
- To gain understanding of current UK-wide antenatal optimisation practices for infants born at periviable gestations.
- To establish an evidence-based conversational structure for pre-delivery periviable decision-making discussions, and a prioritised set of key discussion topics derived from parental consensus and clinician input.
- To develop a set of parent and clinician derived recommendations to improve pre-delivery periviable decision-making conversations.
Research Objectives:
- To benchmark current UK-wide antenatal optimisation intervention rates for periviable infants where active care has been deemed appropriate.
- To record and perform thematic analysis of periviable decision-making conversations between parents and healthcare professionals.
- To determine, then consolidate and stratify, key priority themes for periviable decision-making conversations using parent and clinician derived recommendations and avenues for dissemination.
Research Plan
- Literature Review: Meta-synthesis of literature related to current pre-delivery periviable decision-making conversations and frameworks.
- Semi-structured interviews: Aim: This study phase will determine an evidence-based set of priorities for each group and identify the differences in priorities and barriers that exist in communication between parents and clinicians. Semi-structured interviews will be conducted with 20 parents who have delivered a periviable baby and have experienced a range of outcomes after birth. There will also be interviews with 20 clinicians (equal split between obstetricians and neonatologists). Thematic analysis of the transcribed interviews will be performed to determine similarities and differences in parent and clinician experiences and priorities during pre-delivery periviable decision-making conversations.
- National evaluation of current periviable management practices across the UK. Aim: This study phase will benchmark current periviable practices across the UK, evaluating the extent to which antenatal optimisation interventions (such as antenatal steroids) are utilised for periviable infants where active care was instigated after birth.
- Recording and thematic analysis of periviable decision-making conversations. Aim: This study phase would involve recording real pre-delivery periviable decision-making conversations between clinicians and parents and analysing these for topics discussed, relative time spent on each topic and which management options at delivery were offered. Parents would be invited to participate in a follow-up interview 6 months later to evaluate if the pre-delivery conversation prepared them for the events that followed over their neonatal journey. This would aid evaluation of which conversations were helpful to parents and the structure of those helpful conversations could be used to inform better practice in the future.
- Parent focus groups to consolidate and stratify key priority themes for periviable decision-making conversation and development of parent resources. Aim: This study phase will produce an evidence-based and parent-derived consensus of essential and desirable topic themes for inclusion in pre-delivery periviable decision-making conversations. These defined topic areas will provide a basis for future development of healthcare professional training curricula and the development of a parent information resource about periviable birth.
- Parent survey of parent-assessed long-term outcomes for periviable delivery survivors.
Outcome:
This study will result in a set of evidence-based, prioritised topics for inclusion in periviable discussions between healthcare professional and parent. The study will also conclude with a set of recommendations for how to improve periviable discussion practices. The study results can be used as an evidence-basis to inform policy around periviable birth discussions and to develop clinician education curricula focused on translating the study results into improved everyday clinical practice.
- Conditions
- Periviable Infants, Extreme Prematurity, Communication
- Being tested
- Mixed Methods study
- Keywords
- Periviable Infant, Extreme Prematurity, Delivery Room Management, Communication
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Methods studyOther
Mixed Methods study
| Study group | Role | What they receive |
|---|---|---|
| Semi-structured Interviews | Interviews will be conducted with parents and clinicians regarding their experiences of periviable counselling conversations. The interviews aim to identify key priorities and topic themes for the pre-delivery conversation for both parents and the clinicians, as these are hypothesised to differ between the groups.
* Thematic analysis of transcribed semi-structured interviews with 20 parents and 20 clinicians.
* The recruited parents will encompass a mixture of parent experiences: those with a surviving periviable child, parents whose baby died in delivery room and parents whose baby died in the neonatal unit. Receives: Other: Mixed Methods study | |
| National evaluation of current periviable management practices across the UK. | Review of periviable deliveries and antenatal management practices in the United Kingdom for infants where the decision is for active care at delivery. Receives: Other: Mixed Methods study | |
| Recording and thematic analysis of periviable decision-making conversations | * Recruiting parents who have presented in periviable labour to Manchester Foundation Trust sites.
* Aiming to audio record 20 conversations discussing management options and potential outcomes between healthcare professionals and parents.
* Thematic analysis will be undertake to determine key topics and priorities for parents and clinicians (these may well differ), time taken to discuss each topic, order topics presented, management options offered or requested, and discussion of comfort care. Receives: Other: Mixed Methods study | |
| Comparison of recorded and simulated periviable decision-making conversations | * Recruit 20 senior clinicians from mixture of obstetric and neonatal specialities.
* Clinician will participate in a standardised simulated discussion with two parents (played by actors) who have presented in periviable labour.
* Simulated conversations will be audio recorded and transcribed.
* Analysis will be performed for structure and topics included in this simulated conversation. Comparison will be undertaken comparing the conversational architecture of the simulated conversations with the recorded real conversations (recorded in the above phase of this study). Receives: Other: Mixed Methods study | |
| Focus Groups with parents and clinicians | * Parent focus groups to consolidate and stratify key priority themes for periviable counselling and development of parent resources.
* Clinician focus groups to discuss experiences with training in this area and preferences for future training methods/resources.
* Parents will be recruited from parental advisory groups and local baby groups.
* Aiming to run 5x focus groups with maximum 8 participants in each group. Receives: Other: Mixed Methods study | |
| Parental survey of long-term outcomes | * Survey will be distributed to all parents of surviving periviable deliveries at St Mary's Manchester over the last 2 - 10 years.
* Parents will be asked to complete the survey at home giving their views on their child's strengths, difficulties, development and social interactions.
* The survey also asks parents for their views on what they remember they were told before they delivered and, in light of their experiences, what would they recommend clinicians include in pre-delivery periviable conversations with future parents.
* The survey will be sent to all eligible parents, which equates to 220 surviving infants. All returned surveys will be analysed. Receives: Other: Mixed Methods study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of current periviable delivery management: content of topics discussed in pre-delivery conversations and national rates of antenatal steroid and magnesium sulphate administration and place of birth.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start31 May 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periviable 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
- Other
- Time perspective
- Other
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jennifer Peterson, MBChB, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265195
- Sponsor's protocol ID
- B01416
- Acronym
- ALLIANCE
- Status last verified
- Aug 2023
- First submitted
- 1 Feb 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be available to share. The study team are happy to share sections of anonymised transcripts from the study in the publication. However, no IPD will be available.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeriviAble DeLiveries: ALIgning PArental aNd PhysiCian PrioritiEs (ALLIANCE)
- ClinicalTrials.gov ID
- NCT05265195
- Acronym / sponsor ID
- ALLIANCE / B01416
- Conditions
- Periviable Infants, Extreme Prematurity, Communication
- Keywords
- Periviable Infant, Extreme Prematurity, Delivery Room Management, Communication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 31 May 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 3 Mar 2022 (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.
Background:
There is significant variation in how clinicians currently present information to parents in periviable labour. Whilst each conversation with an individual set of parents will vary, the current level of variation is extreme. In collaborative discussions with the neonatal parental advisory group whilst designing this project, parents reported numerous experiences of significant variation in practice between clinicians in relation to periviable delivery management. There is a pressing issue of injustice here as the hospital or clinician the parent presents to in labour should not restrict their access to information and options for management at delivery.
Parents should be empowered and engaged in making an individualised decision for their infant. However, this is not possible if information is not accurately presented to them. There is a gap in knowledge about what information is vital to include in periviable decision-making conversations between parents and healthcare professionals. This study aims to address this important gap in knowledge.
Research Question: How can information sharing and decision-making conversations between healthcare professionals and parents prior to periviable birth be improved?
Research Aims:
- To gain understanding of current UK-wide antenatal optimisation practices for infants born at periviable gestations.
- To establish an evidence-based conversational structure for pre-delivery periviable decision-making discussions, and a prioritised set of key discussion topics derived from parental consensus and clinician input.
- To develop a set of parent and clinician derived recommendations to improve pre-delivery periviable decision-making conversations.
Methodology:
The study would progress along the following structure:
- Literature Review of literature related to how and what information is presented to parents facing periviable labour by healthcare professionals.
- Semi-structured interviews with clinicians and parents. The aim will be to determine an evidence-based set of priorities for each group and identify the differences in priorities and barriers that exist in communication between parents and clinicians.
- National Evaluation of current periviable management practices across the UK. This will benchmark and expose variation in current practice.
- Analysis of pre-delivery periviable conversations.
- Focus groups with parents and clinicians to consolidate and stratify key priority themes for periviable decision-making conversations and assess acceptability of developing parent-centred periviable delivery resources.
- Parent survey of parent-assessed long-term outcomes for periviable delivery survivors.
Impact and Dissemination:
This study will investigate the key topic areas and conversational structure of pre-delivery periviable decision-making conversations, aiming to provide evidence-based recommendations for improvement.
Detailed description
Research Aims:
- To gain understanding of current UK-wide antenatal optimisation practices for infants born at periviable gestations.
- To establish an evidence-based conversational structure for pre-delivery periviable decision-making discussions, and a prioritised set of key discussion topics derived from parental consensus and clinician input.
- To develop a set of parent and clinician derived recommendations to improve pre-delivery periviable decision-making conversations.
Research Objectives:
- To benchmark current UK-wide antenatal optimisation intervention rates for periviable infants where active care has been deemed appropriate.
- To record and perform thematic analysis of periviable decision-making conversations between parents and healthcare professionals.
- To determine, then consolidate and stratify, key priority themes for periviable decision-making conversations using parent and clinician derived recommendations and avenues for dissemination.
Research Plan
- Literature Review: Meta-synthesis of literature related to current pre-delivery periviable decision-making conversations and frameworks.
- Semi-structured interviews: Aim: This study phase will determine an evidence-based set of priorities for each group and identify the differences in priorities and barriers that exist in communication between parents and clinicians. Semi-structured interviews will be conducted with 20 parents who have delivered a periviable baby and have experienced a range of outcomes after birth. There will also be interviews with 20 clinicians (equal split between obstetricians and neonatologists). Thematic analysis of the transcribed interviews will be performed to determine similarities and differences in parent and clinician experiences and priorities during pre-delivery periviable decision-making conversations.
- National evaluation of current periviable management practices across the UK. Aim: This study phase will benchmark current periviable practices across the UK, evaluating the extent to which antenatal optimisation interventions (such as antenatal steroids) are utilised for periviable infants where active care was instigated after birth.
- Recording and thematic analysis of periviable decision-making conversations. Aim: This study phase would involve recording real pre-delivery periviable decision-making conversations between clinicians and parents and analysing these for topics discussed, relative time spent on each topic and which management options at delivery were offered. Parents would be invited to participate in a follow-up interview 6 months later to evaluate if the pre-delivery conversation prepared them for the events that followed over their neonatal journey. This would aid evaluation of which conversations were helpful to parents and the structure of those helpful conversations could be used to inform better practice in the future.
- Parent focus groups to consolidate and stratify key priority themes for periviable decision-making conversation and development of parent resources. Aim: This study phase will produce an evidence-based and parent-derived consensus of essential and desirable topic themes for inclusion in pre-delivery periviable decision-making conversations. These defined topic areas will provide a basis for future development of healthcare professional training curricula and the development of a parent information resource about periviable birth.
- Parent survey of parent-assessed long-term outcomes for periviable delivery survivors.
Outcome:
This study will result in a set of evidence-based, prioritised topics for inclusion in periviable discussions between healthcare professional and parent. The study will also conclude with a set of recommendations for how to improve periviable discussion practices. The study results can be used as an evidence-basis to inform policy around periviable birth discussions and to develop clinician education curricula focused on translating the study results into improved everyday clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Semi-structured Interviews | – | Other: Mixed Methods studyInterviews will be conducted with parents and clinicians regarding their experiences of periviable counselling conversations. The interviews aim to identify key priorities and topic themes for the pre-delivery conversation for both parents and the clinicians, as these are hypothesised to differ between the groups. * Thematic analysis of transcribed semi-structured interviews with 20 parents and 20 clinicians. * The recruited parents will encompass a mixture of parent experiences: those with a surviving periviable child, parents whose baby died in delivery room and parents whose baby died in the neonatal unit. |
| National evaluation of current periviable management practices across the UK. | – | Other: Mixed Methods studyReview of periviable deliveries and antenatal management practices in the United Kingdom for infants where the decision is for active care at delivery. |
| Recording and thematic analysis of periviable decision-making conversations | – | Other: Mixed Methods study* Recruiting parents who have presented in periviable labour to Manchester Foundation Trust sites. * Aiming to audio record 20 conversations discussing management options and potential outcomes between healthcare professionals and parents. * Thematic analysis will be undertake to determine key topics and priorities for parents and clinicians (these may well differ), time taken to discuss each topic, order topics presented, management options offered or requested, and discussion of comfort care. |
| Comparison of recorded and simulated periviable decision-making conversations | – | Other: Mixed Methods study* Recruit 20 senior clinicians from mixture of obstetric and neonatal specialities. * Clinician will participate in a standardised simulated discussion with two parents (played by actors) who have presented in periviable labour. * Simulated conversations will be audio recorded and transcribed. * Analysis will be performed for structure and topics included in this simulated conversation. Comparison will be undertaken comparing the conversational architecture of the simulated conversations with the recorded real conversations (recorded in the above phase of this study). |
| Focus Groups with parents and clinicians | – | Other: Mixed Methods study* Parent focus groups to consolidate and stratify key priority themes for periviable counselling and development of parent resources. * Clinician focus groups to discuss experiences with training in this area and preferences for future training methods/resources. * Parents will be recruited from parental advisory groups and local baby groups. * Aiming to run 5x focus groups with maximum 8 participants in each group. |
| Parental survey of long-term outcomes | – | Other: Mixed Methods study* Survey will be distributed to all parents of surviving periviable deliveries at St Mary's Manchester over the last 2 - 10 years. * Parents will be asked to complete the survey at home giving their views on their child's strengths, difficulties, development and social interactions. * The survey also asks parents for their views on what they remember they were told before they delivered and, in light of their experiences, what would they recommend clinicians include in pre-delivery periviable conversations with future parents. * The survey will be sent to all eligible parents, which equates to 220 surviving infants. All returned surveys will be analysed. |
Who may qualify
- Ages
- 22 to 24 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will recruit a mixture of participants at various stages of the study: * Parents who have experienced a periviable labour, * Clinicians (Obstetricians, Midwives and Neonatologists) with experience of managing periviable deliveries.
Key inclusion criteria (1 listed)
- Infants born at periviable gestation. For this study periviability is defined as 22+0 - 24+6 weeks gestation.
Key exclusion criteria (2 listed)
- Infants <22+0 or >24+6 weeks gestation.
- Specific inclusion and exclusion criteria apply to each phase of the study.
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 |
|---|---|---|
| Mixed Methods studyMixed Methods study | Other | Comparison of recorded and simulated periviable decision-making conversations, Focus Groups with parents and clinicians, National evaluation of current periviable management practices across the UK., Parental survey of long-term outcomes, Recording and thematic analysis of periviable decision-making conversations, Semi-structured Interviews |
Primary outcome
Measures of current periviable delivery management: content of topics discussed in pre-delivery conversations and national rates of antenatal steroid and magnesium sulphate administration and place of birth.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No. No individual participant data will be available to share. The study team are happy to share sections of anonymised transcripts from the study in the publication. However, no IPD will be available.
Related trials for Periviable Infants
Active, not recruiting
Improve the Survival Without Morbidity of Extremely Preterm Infants (PREMEX)
Newborn, Extreme Prematurity
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.
Jennifer Peterson, MBChB principal investigator
Manchester University NHS Foundation Trust
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 Periviable Infants and Extreme Prematurity, run by Manchester 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 2 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ajit Mahaveer, MBBS (0161 701 2700, ajit.mahaveer@mft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of current periviable delivery management: content of topics discussed in pre-delivery conversations and national rates of antenatal steroid and magnesium sulphate administration and place of birth. (time frame: 3 years). 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 31 Aug 2023.