Let's Talk About Sleep! Project
A feasibility study of a new approach for improving infant sleep-sharing safety
Project management team
Ms Cassandra Yuill, Project Manager Sunderland, Durham University
Dr Catherine Taylor, Project Manager Fife, Durham University
Dr Peter Blair, Co-Investigator, Bristol University
Dr Charlotte Russell, Co-Investigator, Durham University
Prof Helen Ball, Principal Investigator, Durham University
Local clinical team (NHS Sunderland)
Ms Jo Knight, Lead Research Midwife (Oct 2015-Jan 2016)
Ms Kirsten Herdman, Lead Research Midwife (Feb 2016- Jul 2016)
Mr Kim Hinshaw, Local Investigator, Sunderland Royal Hospital
Local clinical team (NHS Fife)
Ms Sharon Black, Research Nurse, NHS Fife / Kirckaldy Hospital
Ms Anette Lobo, Local Investigator, NHS Fife / Kirckaldy Hospital
Sponsor & Funders
Project Sponsor: Durham University
Project Co-Funder: ESRC Impact Acceleration Fund
Project Co-Funder: Lullaby Trust
Project Co-Funder: Scottish Government (Maternl & Infant Health)
Best Beginnings: Ms Helen Hunter
Lullaby Trust: Ms Francine Bates
UNICEF UK: Dr Francesca Entwhistle / Ms Sue Ashmore
Scottish Cot Death Trust: Ms Lynsey Allan
Study design and aims
Two feasibility studies (on in NHS Sunderland and one in NHS Fife) aimed to assess the potential for conducting a large randomised trial of safe-sleep enablers, embedded within an educational intervention for parents at risk of hazardous co-sleeping, within the UK. We sought to develop intervention materials and seek input on them from parent, user, and expert panels; to develop and trial training for health professionals delivering the intervention; and using a pre-test/post-test design to obtain data from 60 control and 60 intervention families on the components of the intervention, data collection at 1 and 2 months postnatally, recruitment and drop-out rates, and adverse events; and assess the potential effectiveness of the intervention and barriers to implementation.
Recruitment & follow-up
A team of half-time research midwives at Sunderland Royal Infirmary conducted recruitment and delivered the intervention in an antenatal setting and on the post-natal ward. A full-time project manager in Durham conducted all data collection, administering questionnaires and sleep diaries via email and by phone, and conducting telephone interviews. The midwifery team approached 208 potential participants (105 control, 103 intervention) and recruited 99 participant families (60 control, 39 intervention). Administering the project in Fife was the responsibility of a full-time project research nurse employed by NHS Fife with the support of a part-time project manager based in Durham who collated the data and completed some of the interviews. Participants were recruited via clinical referrals or face-to-face at Victoria Hospital, Kirkcaldy resulting in 50 participant families (10 control and 40 intervention). Data regarding approaches was not recorded. Overall at both sites, therefore, 70 control and 79 intervention families were recruited. The nature of the intervention was a barrier to some recruitment, as was the restricted pool of eligible participants available in the hospital setting in both locations. Follow-up data collection was conducted by the academic research team for Sunderland and by both the Research Nurse and the academic research manager for Fife. Complete data were obtained for 46 participants (30 control and 16 intervention) in Sunderland and for 34 participants (8 control and 26 intervention (38 control and 42 intervention overall) Offering participants multiple options for completing follow-up surveys (home visits, telephone or online survey) facilitated data capture. Useful feedback was obtained on the data collection tools and participants in both sites described their participation as simple, easy, enjoyable and interesting.
Acceptability of the intervention
The educational materials were highly praised by participants, midwives, and research nurse as being practical and realistic, and providing helpful information. The safe sleep enabler (a clear plastic Baby Bed Box for use in the parental bed as a strategy for avoiding potentially hazardous co-sleeping) was received variably with some participants using it extensively and reviewing it favourably, and others finding it more difficult to use for reasons of design, context. Many of those who chose not to use the box still said that they liked the concept and would recommend it for use by other parents. Overall the intervention appeared to have some effect on aspects of hazardous co-sleeping in Sunderland, particularly sofa-sharing (23% of control vs 6% of intervention participants slept on a sofa with their baby at 1 month), and possibly extreme fatigue (27% of control vs 13% of intervention participants were extremely fatigued at 2 months). Overall, in Fife, although the proportion of sleep diary nights on which co-sleeping was reported was substantially lower in the intervention group than the control group (not significant), the intervention appears to have had little effect on aspects of hazardous co-sleeping: no significant differences were found between the intervention and control groups, but it should be remembered the numbers in the control group in Fife were particularly small. Combined analysis of the Sunderland and Fife data suggest less co-sleeping in the intervention group compared with the control group (mean 6.8 hours compared with mean 2.6 hours at 2 months (not significant). Baby bed boxes were used for a mean of 27 hours over the 10 night data collection period. Qualitative interviews indicated that many of the boxes were also used around the house for day-time sleep, when making overnight visits, and for keeping the baby in close proximity to a carer during the day.
Implications for clinical practice and future research
Further data are needed to ascertain whether there is sufficient evidence to suggest this is an intervention worth pursuing in a large scale (multi-centre) RCT. While we appear to have produced a good educational intervention the Baby Bed Box may require some tweaking. We have established robust methods for data collection and follow-up, but the timing and context of recruitment for a large trial needs to be considered further. The Fife project confirms that face-to-face delivery of the intervention in participants’ homes was received more positively than delivery during antenatal hospital visits.