None listed
Conditions
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.
Interventions
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 p
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.
Sponsors
Sunshine Coast University Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
Yes
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
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
Outcome results
None listed