Approximately 10 000 very preterm babies (born below 32+0 weeks gestation) are born each year in the UK (Tommy's, 2018). Infants born very preterm spend their first weeks or months in a neonatal unit, a stressful environment for infants and parents, especially because of maternal separation (Anderssen et al, 1993). Preterm birth can be difficult for the child, the mother and the development of their relationship (Heydarpour et al, 2017; Stefana and Lavelli, 2017). Hospitalisation and infant ill health interrupt the natural attachment process between a mother and her baby, affecting the mother–infant reciprocal bond (Leahy-Warren et al, 2020). Mothers rarely expect to be discharged home without their baby after birth, and new mothers can experience shock and loss of control because of separation from their newborn (Vigod et al, 2010; Flacking et al, 2012; Neu et al, 2020).
Prior research has shown that anxiety, postpartum depression, post-traumatic stress disorder and reduced overall wellbeing are significantly higher in mothers of preterm babies, with effects persisting for some time, especially in very preterm cases (Vigod et al, 2010; Leahy-Warren et al, 2020). Encouraging breastfeeding, early skin-to-skin contact and family-centred practices can restore parental agency and facilitate reconstruction of parental roles (Neu et al, 2020). Early intervention to address maternal emotional wellbeing and enhance the mother–preterm infant relationship is important.
The device
The Babybe®, ‘Be with my Baby’ system (© 2020 Natus Medical Incorporated, Pleasanton, California) is shown in Figure 1 (Neis-Beeckmann, 2018). It offers an intervention to enhance the mother–preterm infant relationship.
The soft-robotics device, or robotic appliance, is made with soft materials designed for interaction with humans (Rus and Tolley, 2015). Users record their heartbeat and breathing movements with a soft turtle-shaped device, whose recordings play through a special incubator mattress in the mother's absence, as shown in Figure 2 (Brown, 2017; Neis-Beeckmann, 2018; Vitale et al, 2021).
The device intends to re-connect the mother/baby dyad, but the creators make no claims that it improves the occurrences of desaturations, bradycardias or apnoeas (Brown, 2017; Neis-Beeckmann, 2018). This article presents the first results of the COSYBABY study, whose aim was to test whether the device can reduce desaturations, bradycardias or apnoeas. Aside from the potential physiological benefits for very preterm babies, the device may benefit mothers of preterm infants. This nested qualitative study within the randomised controlled trial examined whether the device can reduce maternal stress and worry, while improving the bond between mothers and babies. To understand this, data on mothers' experiences with the device were gathered through rigorous qualitative methods.
Methods
This study used qualitative methods to gather data from mothers on their experiences with the Babybe device, as part of the COSYBABY study. Previous research has demonstrated differences between peoples' questionnaire responses and the information they confide during interviews with researchers (Cornwell, 1984; Lasiuk et al, 2013). Cornwell (1984) shows that unstructured discussion reveal subjective opinions and experiences otherwise withheld from questionnaires, in which participants responded with what they perceived as being the correct view to express. Qualitative methods were used in this study to circumvent this issue.
Recruitment
Inclusion criteria for the study selected infants born on the neonatal unit at a specific hospital in south England before 32+0 weeks gestational age, without life-threatening anomalies who were expected to spend at least 5 days in the neonatal unit's high-dependency unit. A total of 39 preterm infants were recruited to the wider study.
Each baby recruited to the study participated for 5 days, except one. Every care day comprised two 12-hour nursing shifts (10.00-22.00, 22.00-10.00). After receipt of informed consent, each baby was randomly allocated to one of four sequence lists, determining assignment to ‘treatment’ or ‘control’ (standard care). Treatment included recording the mother's heartbeat and breathing at the baby's cot side with the recording device, then playing recordings through the incubator mattress for 12 hours each day. After 5 days, babies were changed to a standard mattress. During the 5 days on-study, all monitoring from the baby's Philips vital signs patient monitor were recorded on a designated laptop.
Public involvement in research development
A video demonstrating the device's functions in the incubator (Babybe, 2015) was shown to a group of mothers of very preterm infants to generate preliminary feedback on the device and the COSYBABY study. This feedback was used to create a 5-question survey on parents' experiences of the COSYBABY study, completed by parents of eight participating babies between December 2020 and February 2021, which researchers reviewed and used to create a focus group topic guide. While the COSYBABY study's hypothesis focuses on outcomes for babies, these focus groups considered parents' experiences.
Focus groups allowed researchers to explore parent views on study design, research participation and the device's impact on maternal stress and worry (Lewis, 2003; Ritchie, 2003). Overall, 39 parents who consented to the COSYBABY study were invited to take part in focus groups via Zoom. A convenience sample of 10 of these 39 parents agreed to participate (Ritchie et al, 2003a). Consent was obtained to record the focus group before commencing. Focus groups explored outcomes that parents attributed to the device, indirectly or directly, and used a set of semi-structured and open-ended discussion questions to allow parents to discuss freely (Lewis, 2003; Ritchie et al, 2003b).
Data analysis
Focus group data were analysed using framework analysis (Lewis, 2003). Initial themes and concepts were identified by reviewing transcribed data, which were then used to construct a thematic index to assign a label to each phrase or passage of the transcripts. Labelled raw data were summarised and synthesised into thematic matrices, to facilitate systematic exploration of the full range of views. Finally, descriptive and explanatory accounts of the data were produced. Data were organised and analysed using NVivo version 1.4. Researchers used the consolidated criteria for reporting qualitative research to illustrate the methods' rigour (Tong et al, 2007). The checklist for this is available on request.
Ethical considerations
Approval was received for the COSYBABY study on 23 March 2020 from the London Camden and Kings Cross Research Ethics Committee (reference number 20/LO/0205). Health Research Authority approval was received on 25 March 2020 from the Health and Care Research Wales Health Research Authority. Informed consent was obtained from parents for the participation of their infant and also their own participation in providing feedback on the study and on using the Babybe device. Research participants were able to withdraw from the study at any time, without having to give a reason.
The individuals pictured in the photographs depicted in Figures 1 and 2 consented to be photographed and for these photographs to be included in this manuscript.
Results
A total of 10 volunteers (nine mothers, one father) contributed to the discussion in three focus groups between January and July 2021, all of whom had participating babies in the COSYBABY study. Five themes were identified: willingness to try anything, supporting mothers, scepticism and searching for causality, limitations of the device and beyond the intervention.
Willingness to try anything
Parents emphasised that the socioemotional context of the neonatal unit affected their decision to participate. Parents felt overwhelmed and that decision making was either clouded by uncertainty or not allowed.
‘I think…information that…gets presented to you when you're a parent in [the neonatal intensive care unit]…it's overwhelming and you want to make the right decision…It's a lot to process. So, I think a lot of the time…it's really hard to know how you feel about anything in the moment.’
Speaker 2.2
Some parents described participation in the COSYBABY study as a solution to feeling powerless in other areas of care.
‘We would try anything if it's going to have a positive effect on them.’
Speaker 2.2
‘You're not responsible for any of his [the child's] decisions when he was first born, and then…he was able to be part of this research study and it was my choice…so it was definitely something I was interested in.’
Speaker 4.2
Some parents were more specific, saying that they wanted to reduce their baby's bradycardias, desaturations, or apnoeas and improve the baby's ‘comfort’ and ‘general mood’. Parents were broadly optimistic about the study and perceived minimal risk to their baby.
‘We were hoping he might benefit from it, and it didn't seem like there was any reason not to try it.’
Speaker 6.2
‘He was getting quite a lot of apnoeas, so I felt, “well, okay. It's not going to harm him. At… minimum, it'll be a bit reassuring for him.”’
Speaker 4.3
Supporting mothers
Positive comments from parents about the device centred around the socioemotional experiences they connected to it. Mothers, especially, described the device favourably, in one case saying it was ‘the only nice thing about the neonatal unit’. Many parents reported corresponding feelings of comfort they attributed to the device. For example, it temporarily reduced their ‘guilt’ surrounding preterm birth and ‘allowed’ them to ‘relax’. Several participants reported leaving the unit earlier, feeling less stressed, and sleeping better during the days that their baby received the intervention.
‘[Before the intervention] I was starting to have…a bit of a struggle about…leaving him and…probably [feeling] selfishly…like it was getting a bit too much at times…I think it was reassuring in a way knowing that…he wasn't just being abandoned…by me and I guess, feeling less guilty.’
Speaker 4.2
The parents personified the device when discussing these benefits and described it as ‘humanising’ the baby's experience on the unit, contrasting with the unit's otherwise ‘sterile environment’. Although parents stated that the device was meant to reduce the baby's apnoeas, they described it as ‘not a medical thing’ and akin to a type of surrogate or proxy mother.
‘It just felt reassuring…when I go home, that [there's] going to be a bit of me left with the baby.’
Speaker 4.3
‘It sounded like a great idea just from doing skin-to-skin cuddles and things like that… I was hoping that …[it] might have the same effect…obviously they stayed inside us for so many months that it's the same thing.’
Speaker 2.1
As intended, these mothers perceived that this would comfort their baby in their absence. However, reactions to the device were complex and not limited to positive, neutral or negative.
Scepticism and searching for causality
Some participants were sceptical of different facets of the device. First, mothers were unsure that the device was playing their own heartbeat and wanted evidence of this, even wishing to hear it for themselves somehow.
‘I was a little bit sceptical about the whole heartbeat thing…I remember speaking…about it because I couldn't quite understand…how we could be a hundred percent certain that it has picked up our heartbeat…because there's no way of testing that…for example, if…[another mother] had used it before I did, and then I'm using it the following week, how do I know it's recorded my heartbeat and overridden… [hers]?’
Speaker 2.2
When this mother voiced concern, another agreed and admitted that she would have also appreciated assurance that the ‘piece’ of her ‘left’ with her baby was her own.
‘It would be good to know more about…the technology behind it. Like how do we actually know that it's doing what it's meant to be doing?’
Speaker 2.1
Second, scepticism around whether it reduced the number of apnoeas or improved medical performance was expressed. One mother reported that her baby's condition worsened after the 5 days of the intervention concluded, making her wonder if the device had caused it.
‘He started having more apnoeas after it turned off again…I don't know if he was reacting to it being turned off or not. It could have been something else, but that was something I noticed.’
Speaker 4.1
Another baby had intense negative symptoms during the intervention.
‘I think it definitely didn't have a positive impact. He had two crashes that week…the nurses needed to call the alarm intervention. One of the scariest weeks we've ever had.’
Speaker 2.2
Many parents also similarly stated that they were unsure of the device's impact because they were unable to observe it operating, as it was activated overnight (22.00–10.00) when they could not attend the clinic. One mother experienced this uncertainty around the device as another discomfort of the unit.
‘For me, it wasn't a comfort. It was more of… another unknown.’
Speaker 2.2
Limitations of the device
Some mothers described their guilt as persisting during the intervention, and beyond. Several mothers indicated that it did not erase the burdens they felt associated with preterm birth.
‘I don't think the guilt ever goes…I think until you get them home with you…you always feel guilty leaving…And my baby's still in hospital, so…I still feel guilty when I leave.’
Speaker 4.1
‘I find it's getting worse, actually.’
Speaker 4.3
The comfort the device brought to parents was tempered by their baby's condition.
‘I definitely agree that if the baby's more unwell… it may not make much difference to the parents.’
Speaker 2.3
Another mother described the burden of clinical needs taking precedence over her ability to process things.
‘He was going into surgery that week. We had a lot of other things…so [the device]…wasn't really something I was particularly thinking about.’
Speaker 2.1
While the device does offer socioemotional benefits to parents, it is important to understand how the unit's realities might slow or reduce these benefits.
Beyond the intervention
Several parents wanted to continue using the device, either on the unit or after discharge.
‘I'd probably buy one if I could.’
Speaker 4.1
‘[Even] people who haven't had premature babies… would love to have something like this at home.’
Speaker 4.2
One mother even noted that she would want a type of ‘Mummybe’ device, where she could access a recording of her baby's heartbeat while her baby was still on the neonatal unit.
‘Do they do it the other way round, where you could record the baby's heartbeat and sleeping and you could have it at home? That would make me feel so much better.’
Speaker 4.3
For future intervention participants, mothers cautioned against ‘giving false hope’, and emphasised the importance of caution in messaging to parents.
‘It doesn't seem like there's any major disadvantages, but it's also hard to say to parents whether there'll be any advantages. So, I think it's just phrasing it carefully so they don't get false hope…you're in a position where you are just willing to try anything to make things better for your baby.’
Speaker 2.1
Most participants said that they wished to have their baby receive the intervention, regardless of what the data would reveal about its influence.
‘Whether those 5 days reduced any apnoeas…even if…it had no impact on him at all, medically, I would still do it again because… it was slightly easier to leave him…knowing that there was a piece of me there.’
Speaker 4.2
Discussion
The focus groups explored whether parents perceived the device to affect their own and their baby's wellbeing, in addition to their perceptions of its impacts on baby's desaturations, apnoeas and bradycardias. There were five themes: willingness to try anything, supporting mothers, scepticism and searching for causality, limitations of the device and beyond the intervention.
The initial qualitative findings suggest potential benefits for broader use of the device may extend beyond the possible impact on the babies' clinical wellbeing, parents' socioemotional wellbeing and their perception of their infant's wellbeing. For parents, a sense of agency in caring for their child may reduce feelings of helplessness or disempowerment. In the face of general uncertainty regarding treatments, survival and precarious infant health, there was evidence from parents that the device provides a feeling of connection to their child at a time when routine care tasks, such as changing and feeding, are frequently undertaken by clinicians rather than parents (Kerr et al, 2017; Lammons et al, 2021).
Patient and public involvement activities and qualitative methodologies add unique insights to studies and randomised controlled trials, both as a means to understand parent experiences of studies and provide additional data that would otherwise go uncaptured (Pezaro et al, 2018; Mannell and Davis, 2019; Phipps et al, 2021; Srivastava et al, 2022). As with other studies that have benefitted from patient and public involvement or qualitative research components (Barnett and Jones, 2015; Pezaro et al, 2018; Phipps et al, 2021; Srivastava et al, 2022), COSYBABY's qualitative components illuminated parent views uncaptured by survey and clinical data. The most significant finding was that parents desired the intervention, even if this meant no ‘medical’ benefits or reductions in their baby's apnoeas, bradycardias or desaturations. This was strengthened by parents' desire for extensions of the device: prolonged intervention, a home device, and a ‘Mummybe’, providing mothers with the baby's heartbeat and breathing recordings. Most parents valued the intangible and socioemotional benefits of the device as at least somewhat ameliorating the difficulties of preterm birth and neonatal intensive care. These difficulties have been documented by other qualitative studies, such as depression, uncertainty and physical separation (Layne, 1996; Mӧrelius et al, 2020). This study benefited from parent emotional wellbeing foregrounded equally with infants' clinical and socioemotional wellbeing, which is unusual in intervention studies. This correspondingly resulted in a novel finding that this device supports mothers when away from the unit. However, interest in the device is messy and complex, because of the high uncertainty in neonatal care.
Limitations
The study's shortcomings include a small, self-selecting sample of 10 parents out of 39 participants, although this is typical for qualitative sample sizes (Ritchie et al, 2003b). These individuals may not be representative of all parents' views and consequently may illustrate strong opinions. A purposive sample would be more robust and illustrative of a wider and more representative range of perspectives (Ritchie et al, 2003b).
Data were collected on babies' apnoea, desaturation and bradycardia occurrences and will be shared with parents as requested. Parental uncertainty of the device's impact on these was understandable, as the intervention set out to test a new hypothesis. However, in future iterations, there will be evidence to support or refute its clinical effectiveness. Parents will then be able to make an informed choice whether to use the device even if purely for socioemotional reasons.
Conclusions
The Babybe device provides socioemotional benefits to mothers of neonatal babies, although health benefits from the device are uncertain and were unknown at the time of the study. This shows that some interventions aimed at neonatal babies may also have socioemotional benefits for parents. Significantly, this would not have been captured without qualitative inquiry, also illustrating broader benefit. Randomised controlled trials and other interventions can benefit from simultaneous data collection on research participants' (or parents', in this case) experiences of the study and qualitative data to broaden the study's understanding of context, outcomes and impact on patients and stakeholders.
Key points
- Mother–infant relationships are key to the development and health of preterm babies and are interfered with when mother and baby are separated because of admission to the neonatal unit.
- This relationship may be supported through interventions such as the Babybe soft robotics device.
- Patient and public involvement activities and qualitative methods as additional study components can provide important data on participants' experiences of the study, which offers greater contextualisation of the main study data.
- Qualitative methods, such as focus groups and discussion can reveal subjective opinions and experiences.
- The Babybe device provides socioemotional benefits to mothers of neonatal babies, although health benefits from the device are uncertain and were unknown at the time of these focus groups.
CPD reflective questions
- What interventions can be used to support mothers of neonatal babies in difficult emotional times?
- How can we involve mothers and parents in research?
- How can we support mothers who have been separated from their babies in a clinical neonatal setting?
- How can we learn from parents to support babies and mothers in clinical settings?
- How can we translate learnings from neonatal research to clinical midwifery practices?