ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000805370

Ethics application status

Approved

Date submitted

26/05/2017

Date registered

1/06/2017

Date last updated

27/06/2019

Date data sharing statement initially provided

27/06/2019

Date results provided

27/06/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Portable neonatal sleep spaces to support optimal breastfeeding, close care and safe sleep in postnatal wards: a pilot

Scientific title

Enabling Safe and Close Care in Postnatal Environments: a pilot trial of portable neonatal sleep spaces to support optimal breastfeeding, close care and safe sleep

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1196-8694

Trial acronym

The ESCCaPE Pilot Trial

Linked study record

n/a

Health condition

Health condition(s) or problem(s) studied:

Safe infant sleeping

breastfeeding

maternal-infant attachment

Condition category

Condition code

Reproductive Health and Childbirth

Breast feeding

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

On arrival to the postnatal unit, participants (mothers of well, term newborns meeting eligibility criteria) will be randomised to one of three options: ‘The First Days Pepi-Pod (inbed cosleeper and postnatal version of the Pepi-Pod)’, ‘The MaBim Neonatal Cot’ (side-car cot) or a standard bedside cot. An allocation to a cot is intended for the duration of hospitalisation.

ARM 1: The First Days Pod is a plastic container equipped with appropriate bedding designed to provide a zone of physical protection around baby as they sleep in an adult bed with a parent/adult caregiver in the postnatal environment. Participants will be shown the Video Clip titled ‘Safe, Sleep, Little One’ (CFOC Ltd, 2016) by the midwife once orientated to the postnatal ward. Participants allocated to the First Days Pepi-Pod will also be asked by the midwife to view the Picture Demonstration (CFOC Ltd, 2016) and the First Days Pod Safety Briefing and have their questions answered. Allocation to the First Days Pod is intended for the duration of hospitalisation.

ARM 2: The MaBim Neonatal Cot is a side car cot that converts to a three sided cot that is positioned adjacent to the adult postnatal bed to allow contact while on a separate sleep surface. All participants will be shown the Video Clip titled ‘Safe, Sleep, Little One’ (CFOC Ltd, 2016) by the midwife once orientated to the postnatal ward. Participants allocated to the MaBim neonatal crib will be shown the MaBim Product Brochure and the MaBim Safety Briefing by the midwife and have their questions answered. Allocation to the MaBim cot is intended for the duration of hospitalisation.

CONTROL: a standard hospital cot. All participants will be shown the Video Clip titled ‘Safe, Sleep, Little One’ (CFOC Ltd, 2016) by the midwife once orientated to the postnatal ward. Participants randomised to the control group (usual cot care) will receive standard care instructions including Hospital Cot Safety Briefing provided by the midwife and have their questions answered.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Behaviour

Comparator / control treatment

The Control treatment is a standard hospital perspex cot.

Control group

Active

Outcomes

Primary outcome [1]

Maternal acceptability of infant sleep spaces; assessed by Questionnaire (author developed)

Timepoint [1]

Prior to discharge if hospital birth ?within 1-3 days post birth for vaginal deliveries and within 3-5 days post birth for caesarean deliveries)

Primary outcome [2]

Staff perspectives of protocol feasibility in postnatal environment; assessed by Questionnaire (author developed)

Timepoint [2]

at 16-20 weeks post study commencement

Secondary outcome [1]

Maternal satisfaction with care; assessed by Maternal Satisfaction Questionnaire (ICHOM Pregnancy and Childbirth standard set (ICHOM, 2016)

Timepoint [1]

Prior to discharge if hospital birth ?within 1-3 days post birth for vaginal deliveries and within 3-5 days post birth for caesarean deliveries)

Secondary outcome [2]

Provision of culturally appropriate care/personal options and choice assessed by Demographic Questionnaire (author developed)

Timepoint [2]

Prior to discharge if hospital birth ?within 1-3 days post birth for vaginal deliveries and within 3-5 days post birth for caesarean deliveries)

Secondary outcome [3]

Breastfeeding method assessed by Breastfeeding Success Variable (ICHOM 2016)

Timepoint [3]

Prior to discharge if hospital birth ?within 1-3 days post birth for vaginal deliveries and within 3-5 days post birth for caesarean deliveries); at infant age 6-8 weeks; at infant age 4 months

Secondary outcome [4]

Breastfeeding Self-Efficacy assessed by Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) (Dennis 2003)

Timepoint [4]

Prior to discharge if hospital birth ?within 1-3 days post birth for vaginal deliveries and within 3-5 days post birth for caesarean deliveries); at infant age 6-8 weeks; at infant age 4 months

Secondary outcome [5]

Maternal-Infant Attachment assessed by Mother-to-Infant Bonding Scale (MIBS) (Taylor et al 2005, ICHOM 2016)

Timepoint [5]

Prior to discharge if hospital birth ?within 1-3 days post birth for vaginal deliveries and within 3-5 days post birth for caesarean deliveries); at infant age 6-8 weeks; at infant age 4 months

Secondary outcome [6]

Maternal awareness of Safe Sleeping recommendations assessed by Maternal Safe Sleep Awareness Questionnaire (Schluter and Young 2002)

Timepoint [6]

Prior to discharge if hospital birth ?within 1-3 days post birth for vaginal deliveries and within 3-5 days post birth for caesarean deliveries); at infant age 6-8 weeks; at infant age 4 months

Secondary outcome [7]

Postnatal Incidence of shared sleeping assessed by Infant Sleep Observation Audit

Timepoint [7]

Prior to discharge if hospital birth ?within 1-3 days post birth for vaginal deliveries and within 3-5 days post birth for caesarean deliveries)

Secondary outcome [8]

Maternal reported shared sleeping assessed by Maternal Safe Sleep Awareness Questionnaire

Timepoint [8]

Prior to discharge if hospital birth ?within 1-3 days post birth for vaginal deliveries and within 3-5 days post birth for caesarean deliveries); at infant age 6-8 weeks; at infant age 4 months

Secondary outcome [9]

Maternal length of stay assessed by Maternal Chart Audit of admission and discharge dates

Timepoint [9]

at Discharge from postnatal unit

Secondary outcome [10]

Pre Intervention Staff Awareness of Safe Sleep Recommendations assessed by Staff Safe Sleep Questionnaire and Chart Audit (Young and Schluter 2002, Young et al 2008)

Timepoint [10]

at 4 weeks prior to study commencement

Secondary outcome [11]

Post Intervention Staff Awareness of Safe Sleep Recommendations assessed by Staff Safe Sleep Questionnaire and Chart Audit (Young and Schluter 2002, Young et al 2008)

Timepoint [11]

at 16-20 weeks post study commencement

Secondary outcome [12]

Staff acceptability of infant sleep spaces; assessed by Questionnaire (author developed)

Timepoint [12]

at 16-20 weeks post study commencement

Secondary outcome [13]

Postnatal adverse events assessed through PRIME system (records baby falls, adverse events from maternal beds or chairs)

Timepoint [13]

At discharge if hospital birth ?within 1-3 days post birth for vaginal deliveries and within 3-5 days post birth for caesarean deliveries)

Eligibility

Key inclusion criteria

Maternal participants
- greater than or equal to 36 weeks of gestation at time of consent
- Attending the SCUH for antenatal care
- Intending to be admitted to the postnatal ward at the SCUH after the birth
- English speaking
- Intending to breastfeed
- Singleton pregnancy
- BMI less than 40
- greater than or equal to 15 years of age
- Ability to read and understand English

Minimum age

15 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- less than 36 weeks of gestation at time of consent
- Maternal condition which significantly interferes with breastfeeding
- Intending to feed infant with artificial formula
- Maternal BMI greater than or equal to 40
- less than 15 years of age
- Multiple pregnancy
- Newborn admitted to SCN or NICU immediately after birth
- Neonate requiring phototherapy with or without CPAP
- Inability to read and understand English

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed opaque envelopes - for randomisation process by staff to Treatment groups: First Day Pod, MaBim Cot, Standard Cot

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by
computer software (i.e. computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

A target sample of 180 maternal participants and their babies will be recruited (approximately 60 in each group) in this Pilot Study to allow an attrition rate of 50% during the 4 month follow-up period in order to achieve a final sample of 90 participants (with 30 mother-infant pairs in each group). The primary aim of this pilot is to gather observational data relating to the feasibility and acceptability of the Safe Sleep Enabler options and to test the non-blinded, randomised control trial protocol intended for a larger study.
Based on an estimated 30-40 eligible births per week at this regional hospital, and taking into account conservative participation rates of 40% and attrition post enrolment (50%), in addition to average length of hospital stay (approx. 1-3 days for vaginal deliveries, 3-5 days for delivery by caesarean section), it is anticipated that a maximum recruitment period of 5-6 months will be required to achieve the target sample of 180 eligible mothers and their babies with complete datasets.
The estimated staff population is approximately 80 nurses and midwives; it is anticipated that a target sample size of approximately 65-70 staff (approx. 80% response rate) will be achieved based on previous study participation with this cohort. Power calculations have not been conducted as the population is fixed by the maternity unit setting, and the primary aim of the pilot was to determine feasibility of the protocol and staff acceptance and use of a novel safe sleep enabler in this environment.
Audits of maternal charts and infant sleep observations prior to pilot RCT have been included to provide important baseline relating to current safe sleep practices in this setting. The sample size of 90-100 infant sleep observations and matched maternal chart audits will be adequate to provide a snapshot of current practice; to compare with data collected in previous studies in similar settings (Young et al., 2010); is feasible to collect within a relatively short period of time using in-kind time and resources available to the investigating research team; and provides the SCUH with valuable data to meet state guideline recommendations relating to current monitoring of safe sleep practices (Queensland Health, 2013).
Data analysis
Pilot Data collection and analyses will include maternal and infant demographics; breastfeeding outcomes (at discharge, 6-8 weeks and 4 months); length of stay; maternal-infant attachment; maternal satisfaction and perceptions relating to enabler use; staff time to recruit and educate families, perceptions relating to intervention impact and adverse events; and maternal and staff awareness of safe sleep recommendations (self reported and observed).
Maternal Data: Analysis of maternal data will be conducted using the principles of intention to treat. All participants who were enrolled and randomly allocated to treatment will be included and analysed in the groups to which they were randomised. A further analysis will be based on actual use, consistent with a recent published study using Wahakura (Baddock et al., 2017) which performed analyses based on intention to treat and actual use.
Statistical analyses will be performed to report the prevalence and proportions of variables surveyed. Questionnaire results will be entered into a purpose-built Microsoft Excel database for data cleaning and preparation for statistical analysis. A 10% random selection (approximately 9-10 questionnaires from each of the maternal records, staff survey and audits) will be double entered to assess data-entry accuracy and intra-rater reliability. Consistency checks will be performed on all variables to ensure that only valid responses will form the basis of the ensuing analysis.
Quantitative data will be analysed using descriptive techniques such as frequency and percentage and measures of central tendency and distribution (for example, mean and standard deviation or median and IQR). Normality of data will be assessed. Group comparisons to comparing equivalency of control and interventions will be conducted with Chi-squared test for categorical measures and analysis of variance or Kruskal-Wallis test for continuous measures as appropriate assessing for normality and equality of variances.
Staff Survey Data: Should continuous data be distributed symmetrically, then means and standard deviation (SD) will be reported. Medians, inter-quartile ranges (IQR), frequencies and percentages will be used to report the central tendency, spread and empirical distributions of categorical and non-symmetric continuous variables elicited at each survey. All bivariate comparisons of categorical frequencies will be undertaken using Fisher's exact test, log-linear and logistic models, while McNemar’s test and Agresti's test of symmetry will be used to detect differences between participants' responses at any two survey points (pretest vs post-test). Continuous data will be analysed using Student's t-test, Student's paired t-test, ANOVA or using their nonparametric equivalents (should the data exhibit non-normality).
Audit data: All qualitative data will be coded prior to data entry. Frequency data will be reported and analysed using standard categorical techniques (accounting for the matched nature of the data between mother and baby). Univariate linear modelling will be conducted for dependent variables that will include infant sleep position, infant placement in the cot, placement and securement of bedding; and presence of particular objects in the cot, e.g. Infant quilts, toys, cot bumpers.
All statistical comparisons will be analysed using the SAS or SPSS statistical software package (IBM Corp 2013). A value of p=0.05 will be used to define statistical significance for primary outcomes as they are independent of each other. We recognize that there are a large number of secondary outcomes and will report uncorrected p values with a nominal level of significance of 0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/08/2017

Actual

5/03/2018

Date of last participant enrolment

Anticipated

28/02/2018

Actual

10/08/2018

Date of last data collection

Anticipated

26/06/2018

Actual

5/12/2018

Sample size

Target

160

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Sunshine Coast University Hospital - Birtinya

Recruitment postcode(s) [1]

4575 - Birtinya

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Wishlist Sunshine Coast Health Foundation

Address [1]

Wishlist Sunshine Coast Health Foundation
PO BOX 2610
Nambour West
QLD 4560

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sunshine Coast University Hospital

Address

Sunshine Coast University Hospital
16 Innovation Parkway
Birtanya QLD 4575

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of the Sunshine Coast

Address [1]

University of the Sunshine Coast
Sippy Downs Drive
Sippy Downs
QLD 4556

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Human Research Ethics Committee

Ethics committee address [1]

RBWH HREC
MetroNorth Hospital and Health Service
Level 7, Block 7
Royal Brisbane and Women's Hospital
Butterfield Street, Herston  QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/05/2017

Approval date [1]

17/05/2017

Ethics approval number [1]

HREC/17/QRBW/162

Ethics committee name [2]

University of the Sunshine Coast Human Research Ethics Committee

Ethics committee address [2]

Sippy Downs Drive
Sippy Downs
Queensland 4566

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

10/07/2017

Approval date [2]

21/08/2017

Ethics approval number [2]

A17991

Summary

Brief summary

Reducing infant mortality and morbidity,and promoting breastfeeding, remain public health priorities. Sharing a sleep surface with a baby is a common, often culturally valued infant care practice that promotes breastfeeding but under certain circumstances increases risk of infant death. Limited published research has evaluated portable sleep spaces that allow close parent-baby proximity on the same or immediately adjacent sleep surface, especially within hospital environments. 
This pilot aims to determine acceptability, feasibility, safety and impact on breastfeeding outcomes and maternal-infant attachment of two safe sleep enablers within the SCHHS maternity unit. Families will be recruited at the 36-weeks antenatal visit. Eligible, consenting postpartum women admitted to postnatal ward (target sample n=180) during a 4-month period will be allocated either a First Days Pepi-Pod, MaBim Side-Car Crib or a Standard Hospital Cot.
The priority of the pilot is to test the novel concept of safe sleep enablers for the first time in an Australian setting. Two primary hypotheses will focus on maternal acceptability of the safe sleep enablers as alternative infant sleep spaces and the feasibility of the proposed protocol in a busy maternity setting.
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
and
4.	Describe clinical outcomes of the safe sleep enabler group and control (including        
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.

The primary hypotheses are:
1.	Acceptability with infant safe sleep enablers will be demonstrated by mothers in the maternity unit setting.
2.	Feasibility of a pilot protocol to evaluate safe sleep enablers in the maternity unit setting will be demonstrated (as measured by staff support, appropriate application of the protocol: consent, randomisation, documentation processes).

This will be a pilot feasibility study in the first instance, intended to support the design of a non-blinded, randomised controlled trial in the future. The study will use a concurrent mixed methods design conducted in three phases.

Trial website

https://www.usc.edu.au/research-and-innovation/medical-and-health-science/nurture/research-projects/the-esccape-trial

Trial related presentations / publications

n/a

Public notes

WIN Canberra/Townsville/Wide Bay: News Segment broadcast 20th July 2017. Jeanine Young discusses Pepi-Pod project to reduce infant mortality (Safe sleep enabler trial at SCUH). Available at  https://www.facebook.com/WINNewsSunshineCoast/?hc_ref=ARTuxyXfpTkAr90KHAz0Rq6-0rlO5RRKM4JpLLrJdLMmIHeMSsZfSPYbmXtf77eHZZI&pnref=story (>2000 views as of 28 July 2017)

Attachments [1]

/AnzctrAttachments/373027-ESCCaPE_Protocol_CLEAN_V1.1_20170505.pdf (Protocol)

Attachments [2]

/AnzctrAttachments/373027-17-162 signed approval 17May17.pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/373027-ESCCaPE_SSD_PISCF_MASTER_CLEAN_V1.1_20170503.doc

Attachments [4]

/AnzctrAttachments/373027-ESCCaPE_StaffQuestionnaire_PIS_MASTER_CLEAN_V1.1_20170503.doc

Contacts

Principal investigator

Name

Prof Jeanine Young

Address

School of Nursing, Midwifery and Paramedicine,
University of the Sunshine Coast
Sippy Downs Drive
Sippy Downs QLD 4556

Country

Australia

Phone

+61754565898

Fax

+61754565940

jyoung4@usc.edu.au

Contact person for public queries

Name

Jeanine Young

Address

School of Nursing, Midwifery and Paramedicine,
University of the Sunshine Coast
Sippy Downs Drive
Sippy Downs QLD 4556

Country

Australia

Phone

+61754565898

Fax

+61754565940

jyoung4@usc.edu.au

Contact person for scientific queries

Name

Jeanine Young

Address

School of Nursing, Midwifery and Paramedicine,
University of the Sunshine Coast
Sippy Downs Drive
Sippy Downs QLD 4556

Country

Australia

Phone

+61754565898

Fax

+61754565940

jyoung4@usc.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Data relating to the use of novel sleep spaces in postnatal units:
De-identified qualitative data - maternal responses
De-identified survey data - maternal responses (breastfeeding, maternal-infant attachment)
De-identified survey data - Health professionals - knowledge, attitudes relating to safe sleeping recommendations

When will data be available (start and end dates)?

Start Date: 14 December 2018 (when data collection closed on last participant)
End Date: No end date determined

Available to whom?

Researchers - upon request

Available for what types of analyses?

Systematic reviews/Meta-analyses of health professional knowledge and attitudes relating to safe sleep recommendations
Systematic reviews/meta-analyses relating to outcomes associated with portable infant sleep spaces

How or where can data be obtained?

USC Research Bank

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2211	Study protocol					373027-(Uploaded-29-05-2019-16-19-55)-Study-related document.pdf
2212	Informed consent form					373027-(Uploaded-29-05-2019-16-19-55)-Study-related document.docx

Results publications and other study-related documents

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No additional documents have been identified.

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