The ESCCaPE Trial

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The ESCCaPE Trial

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Enabling Safe and Close Care in Postnatal Environments: A Pilot

Introduction

Sharing a sleep surface with a baby is a common occurrence worldwide, especially for breastfeeding mothers and their babies. The practice of bed-sharing however, has been associated with an increased risk of sudden unexpected death in infancy, including sudden infant death syndrome (SIDS) and fatal sleeping accidents, in some circumstances (Blair et al., 2014; Carpenter et al., 2013).

Challenges exist in the immediate hours and days following birth to support closeness and skin to skin to promote maternal-infant attachment and breastfeeding, whilst providing an environment that protects the newborn infant’s airway and promotes uptake of safe sleeping messages that new parents will also implement at home. Healthcare providers play an integral role in modelling safe sleep environments and infant care practices.

Although limited evidence exists, several trials have reported positive results in mother-baby interaction, infant safety and breastfeeding establishment when devices that facilitate close proximity on a separate sleep surface are used. Trials of portable sleep spaces designed for in-bed use in Queensland Indigenous communities (Queensland Pēpi-Pod Program) have reported acceptability, feasibility and increased safe sleeping awareness to date.

This study will evaluate a novel approach that aims to address the need for close mother-baby contact, safety, parent education and awareness (regarding safe sleeping), as well as continuity of care from hospital to home, through the use of two co-sleeping devices in the immediate postnatal environment. This will be the first trial of its kind in an Australian hospital environment.

Aim

The aim of this study is to pilot two neonatal infant sleep spaces designed to promote closeness and safe sleeping environments in the postnatal environment, within the Sunshine Coast Hospital and Health Service. The Safe Sleep Devices (SSD) to be used include ‘The First Days Pēpi-Pod®’ and ‘The MaBim Side-Car Crib’.

Objectives

This pilot study aims to determine:

  1. Acceptability and maternal satisfaction with a safe sleep enabler;
  2. Acceptability of safe sleep enablers (intervention) by staff working within a busy postnatal maternity unit;
  3. Feasibility of a large randomised controlled trial using the proposed protocol;
  4. Clinical outcomes of the safe sleep enabler group and control (maternal satisfaction with care options, breastfeeding initiation and duration, maternal-infant attachment, awareness of safe sleeping recommendations, incidence of shared sleeping, length of stay) to inform protocol revisions for the larger randomised controlled trial.

Methods

This will be a pilot observational descriptive study in the first instance, intended to support the design of a non-blinded, randomised controlled trial in the future. A concurrent mixed methods study design will be implemented in three phases.

Phase 1

Infant Sleep Observation and Chart Audit

The Pre-test Infant Sleep Observation (n=100) involves an observational assessment of participating infants nursed in the Postnatal Unit. Infant sleep position and infant sleep environment will be observed and documented using an audit tool. This assessment will particularly focus on infant sleep position and sleeping environment (consistent with current safe sleeping messages e.g. baby placement in cot, bedding used and placement, presence of objects in cot).

Maternal charts (n=100) will be audited to determine staff documentation of care and discharge information provided to parents/caregivers regarding safe sleeping messages.

Phase 2

Safe Sleep Device

The Safe Sleep Device interventional phase of the study, involves randomly allocating (on admission to the postnatal unit) participants to the MaBim side-car crib (n=30), First Days Pēpi-Pod® (n=30) or control (n=30) (usual care with baby sleep space being independent hospital Perspex cot on wheels) during the postnatal stay.

Infant Sleep Observation and Chart Audit

Post-test Infant Sleep Observations and Maternal Chart Audits will be undertaken on participating mothers and babies prior to discharge.

Questionnaires

Participants will be followed up by the Research Assistant/Midwife to assess breastfeeding rates, acceptability of the devices, maternal-infant attachment, maternal satisfaction with the care received, culturally appropriate care, accessibility of personal options and choice in care, adverse events and awareness of, and compliance with, safe sleeping recommendations. These questionnaires will be conducted during the hospital admission, six to eight weeks and four months after birth.

Phase 3

Staff Questionnaires

Pre-and Post-test Questionnaires will be conducted with eligible staff in the Postnatal Unit (n=80) to assess knowledge, attitudes and practices relating to safe infant sleeping practices.

Results

It is anticipated that the findings of this pilot will provide the platform for a larger randomised controlled trial (RCT). The RCT would aim to provide high quality evidence for the effectiveness of postnatal safe sleep enablers in improving optimal breastfeeding outcomes and parental uptake of safe sleep behaviours to reduce the risk of sudden unexplained death in infancy, including SIDS and fatal sleeping accidents.

Conclusion

This study addresses two internationally identified health priorities of relevance to Queenslanders; supporting breastfeeding and reducing infant mortality and morbidity (WHO, 2016). This timely and innovative trial addresses current clinical practice and safety issues experienced by the local hospital and health service, however it has the potential to improve the health outcomes of all Australian mothers and infants.

Awards

The ESCCaPE Trial has been awarded a Wishlist Grant from the Sunshine Coast Health Foundation for amount of A$19,993.05.

Approvals

Ethical approval has been obtained from the Royal Brisbane and Women’s Hospital Human Research Ethics Committee. For ethical concerns regarding the conduct of this study please contact:

Human Research Ethics Office
Royal Brisbane and Women's Hospital
Level 7, Block 7
Butterfield Street
Herston  QLD  4029

Tel: +61 7 3646 6132
Email: RBWH-Ethics@health.qld.gov.au

Associations

The ESCCaPE trial is a collaboration between the Sunshine Coast Hospital and Health Service, the University of the Sunshine Coast and Change for Our Children Ltd. The study investigators include:

More information

Contact Professor Jeanine Young, Chief Investigator, The ESCCaPE Trial.

For further information on the New Zealand and Australian Pepi-Pod® Safe Sleep Programs please see:

References

Blair PS, Sidebottom P, Pease A & Fleming PJ. (2014). Bed-Sharing in the Absence of Hazardous Circumstances: Is There a Risk of Sudden Infant Death Syndrome? An Analysis from Two Case-Control Studies Conducted in the UK. PLoS ONE, 9(9), e107799. DOI: 10.1371/journal.pone.0107799

Carpenter R, McGarvey C, Mitchell, EA, Tapping DM, Vennemann MM, Smuk S, Carpenter JR. (2013) Bedsharing when parents do not smoke: is there a risk of SIDS? An individual level analysis of five major case-control studies. British Medical Journal Open 3(5):e002299. doi:10.1136/bmjopen-002299

World Health Organisation (2016). Children: reducing mortality (Factsheet)

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