Development and feasibility of a co-produced intervention to enhance parental involvement in facility neonatal care in India, Pakistan and Tanzania
| ISRCTN | ISRCTN11273035 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11273035 |
| Secondary identifying numbers | 22-009 |
- Submission date
- 03/08/2022
- Registration date
- 12/08/2022
- Last edited
- 12/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
In recent decades improvements in neonatal care (NNC) have reduced the numbers of babies born early or who are sick at birth dying soon after birth around the world. However, babies born small or sick in sub-Saharan Africa or South Asia are still much more likely to die than babies born in high income countries (HICs). Babies needing neonatal care after birth are usually separated from their parents with most of the care being provided by health workers and this is known to have negative impacts on physical, psychological, and emotional health of both parents and infants. Following the philosophy of family- centred care, new ways of caring for babes in NNU in HIC have been developed where parents are encouraged to become more actively involved in the care of their baby. In some countries this approach has been developed so that parents receive education and support and are able to provide much of the care the baby needs with help from neonatal nurses and doctors. Research has shown that increased involvement can help improve the baby’s health including weight gain and reduce the chance of infection in hospital. Mothers who were involved also experienced less stress and anxiety.
Increasing parents’ involvement in NNC could also improve outcomes for babies and parents in sub–Saharan Africa and South Asia, however differences in the way care is provided, lack of resources, social and cultural differences mean that strategies used in other settings might not be workable or effective. Research is needed to understand more about current care and parents’ experiences and develop a specific intervention for these settings.
In this study in hospitals in India, Pakistan and Tanzania, we will explore the experiences of parents whose baby was in NNU and health workers who regularly provide care to understand needs and the barriers and facilitators to change. Working with local parents, health workers and managers we will use this information along with previous research on the same topic to agree a new package to improve partnerships with parents in neonatal care, this could include education, a more welcome environment and emotional support. We will then assess whether it is possible to conduct research to test the package by introducing the change with a small number of parents and babies whilst they are in the NNU within hospitals in these three countries. We will assess whether parents are willing to take part and stay in the research study, whether the change works as planned and the best ways of assessing the effect on well-being and services. If this is study is successful, we will seek funding for a larger study to assess whether this change would benefit babies and parents and families, represents good value for money and should be introduced across similar settings.
Who can participate?
Mother and babies who are cared for the in neonatal unit of the included sites in India, Pakistan or Tanzania for at least 7 days, family members and health workers involved in delivery of the study intervention
What does the study involve?
In phase 1 (usual care) participants will be asked for permission to collect details about their maternity care and the baby’s care in hospital, they will meet with the research assistant 3 times (at recruitment, before baby is discharged and 6-8 weeks after discharge to collect data and complete questionnaires. In phase 2, in addition participants will be offered the study intervention (to be confirmed) and invited to an interview completed at the 6-8 week data collection visits. Family members of participants in phase 2 (intervention phase) and health workers will be invited to participate in an interview at the end of the study
What are the possible benefits and risks of participating?
The study is not intended to directly benefit participants, we hope the study intervention might help women and families participating in phase 2 feel better supported, but cannot guarantee this will be the case. Discussing events related to the birth of a small and or sick baby could cause distress to parents, but the researchers are trained to provide support. The information we get will help to improve the care of small and sick babies in the future.
Where is the study run from?
Liverpool School of Tropical Medicine (UK)
When is the study starting and how long is it expected to run for?
April 2022 to December 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dr Tracey Mills, tracey.mills@lstmed.ac.uk
Contact information
Public
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
 ORCID ID |
0000-0002-2183-7999 |
|---|---|
| Phone | +44 151 8321694 |
| tracey.mills@lstmed.ac.uk |
Study information
| Study design | Mixed methods feasibility study conducted in two sites |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact detail to request a participant information sheet |
| Scientific title | Enhancing parental involvement in the care of sick neonates in India, Pakistan and Tanzania: A Participatory Action Research Study |
| Study objectives | To explore the potential of parent partnerships in facility neonatal care to improve outcomes for small and sick newborns |
| Ethics approval(s) | 1. Approved 05/07/2022, Liverpool School Tropical Medicine REC Committee (Pembroke Place, Liverpool, L3 5QA, UK; +44(0)151 705 3100; lstmrec@lstmed.ac.uk), ref: 22-009 2. Approved 20/05/2022, Catholic University of Health and Allied Sciences (CUHAS, Bugando, CUHAS Ethical Committee, Mwanza, Tanzania PO BOX 1464; +255282983384; VC@bugando.ac.tz), ref: 22-009 |
| Health condition(s) or problem(s) studied | Parent partnerships in facility neonatal care to improve outcomes for small and sick newborns |
| Intervention | A co-production process will be initiated involving representatives from NIHR Unit stakeholders (including local clinicians, policy makers and community leaders) and Community Engagement Groups of local parents with previous experience of neonatal care, in each site. The findings from the literature review and exploratory study will be presented at an in-person meeting, or a virtual meeting if travel is restricted. A series of follow-on meetings will be convened in each site to identify potential intervention components based on priorities identified during the phase 1. Intervention design will be guided by the philosophy of family-centred care which emphasises involvement of parents in their child’s medical care in partnership with health workers through principles of dignity and respect, information sharing, participation, and collaboration. Currently there is insufficient evidence from LMIC settings including Africa and Asia to guide the content of the intervention/model. However, in HIC settings the Family Integrated Care (FIC) model has actioned these principles integrating parents into neonatal care using a ‘four pillar’ approach with activities to support each component. Some or all these components may be considered for the model(s), but in keeping with PAR, the final decision will be made by the site groups. A ‘learning and sharing event’ in month 21, will bring representatives of all three countries together in person (or virtually if required) to share experiences in the co-production process and finalise implementation strategies incorporating the Behaviour Change Wheel, and human-centred design which will aid us in embedding human perspectives and empathy in the intervention components |
| Intervention type | Behavioural |
| Primary outcome measure | Recruitment and retention of mothers (caregivers) and babies in the study. Recruitment and retention is measured, using the study screening and recruitment log at identification of each eligible participant, approach, recruitment and study completion, withdrawal or loss to follow up. |
| Secondary outcome measures | 1. Acceptability of the intervention, research and study processes for parents and health workers is assessed using qualitative interviews conducted at the end of the intervention phase, 6-8 weeks following discharge (parents) and at the end of the intervention phase (health workers directly involved in the delivery of the intervention) and a survey questionnaire for all neonatal and maternity staff providing newborn care 2. Characteristics and acceptability of the proposed psychological measures is assessed with mothers/caregivers recruited to the study at the following time points: 2.1. Parental stressor scale: Neonatal intensive care unit (PSS:NICU; measures parental anxiety and stress) baseline (recruitment), immediately prior to baby’s discharge from NNU, 6-8 weeks following discharge 2.2. Edinburgh postnatal depression scale: (assesses depressive symptoms in the postnatal period EPDS) baseline (recruitment), immediately prior to baby’s discharge from NNU, 6-8 weeks following discharge |
| Overall study start date | 01/04/2022 |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 mother/baby pairs |
| Key inclusion criteria | Mother/Caregiver/baby pairs 1. Baby admitted to NNU and expected to remain for >7 days 2. Mother (caregiver) willing to commit to the study intervention (intervention phase only) 3. Mother (caregiver) over 18 years at recruitment Partner/Family member 1. Partner or family member of mother (or caregiver). 2. Over 18 years old at time of recruitment Health workers, service managers, peer supporters 1. Nurses, midwives, doctors directly involved in the delivery of the intervention 2. Peer supporters (parents with prior lived experience) if involved in delivery of the intervention |
| Key exclusion criteria | 1. Multiple births where one only baby received NN care and/or is still living 2. Baby receiving palliative care 3. Baby critically ill (e.g receiving ventilatory/ organ support and/or not expected to survive) 4. Severe congenital abnormality |
| Date of first enrolment | 01/10/2023 |
| Date of final enrolment | 01/10/2024 |
Locations
Countries of recruitment
- India
- Pakistan
- Tanzania
Study participating centres
Karnataka State
Hubbali
580020
India
Sindh
Jamshoro
76090
Pakistan
Mwanza
-
Tanzania
Sponsor information
University/education
Research Governance and Ethics Office
Room 221
2nd Floor LLSA
Daulby Street
Liverpool
L3 5QA
England
United Kingdom
| Phone | +44 151 702 9396 |
|---|---|
| Denise.Watson@lstmed.ac.uk | |
| Website | http://www.lstmed.ac.uk/ |
"ROR" |
https://ror.org/03svjbs84 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Active dissemination will include the usual 'business-to-business' model (funder reports, plain language summaries, conference presentations and academic journal papers) balanced with publicly accessible sources (newspapers, broadcast, and social media) and policy focus (briefs, bulletins). All researchers and CEI members will be invited to have an active role in dissemination. The results from this work will be published as soon as possible. All papers will be submitted to high-level open access health journals. The Uniform Requirements for Manuscripts Submitted to Biomedical Journals (http://www.icmje.org/) will be used to assist with clear reporting. Individual researchers must undertake not to submit any part of their individual data for publication without the prior consent of the UMG. Local dissemination meetings will be held in Hubbali, Karachi and Mwanza for policymakers, health care providers and community members. Regional and International dissemination will be carried out through the LAMRN Network and International Stillbirth Alliance (ISA), amongst others. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Tina Lavender (tina.lavender@lstmed.ac.uk). Type of data: anonymised quantitative and qualitative. Available following the full publication of findings and for 5 years following completion and publication of results. |
Editorial Notes
12/12/2024: The overall study end date was changed from 31/12/2024 to 30/06/2025.
12/08/2022: Trial's existence confirmed by Liverpool School of Tropical Medicine.
