The SLUMBRS Feasibility Study

Feasibility studies are pieces of research done before the main study in order to answer the question “Can this study be done?” They are used to determine important information needed to design the main study.

The SLUMBRS feasibility study helped answer questions like:

  • The number of participants needed to answer the research question of “What is the best sleeping position for children with cleft palate?”
  • How do participants feel about being randomly assigned a sleeping position for their baby?
  • How willing are clinicians to help recruit participants?
  • How long is needed to collect and analyse data?

The SLUMBRS2 study will assign sleeping positions at random, but this feasibility study was not randomised as it took place in Cleft Centres that gave different advice about sleeping positions.

Crucially, the SLUMBRS feasibility study did not attempt to answer the question: “Which is the best sleeping position for children with cleft palate? That will be answered by SLUMBRS2.

Findings of the Feasibility Study

As you will see from summaries of the SLUMBRS feasibility study below, it has shown that the main trial (SLUMBRS2) will be feasible, and that the question of what is the best sleeping position for infants with the cleft palate is still important for clinicians and parents.

Safe sleeping positions: practice and policy for babies with cleft palate Davies et al. 2017

In order to reduce the risk of sudden infant death syndrome (SIDS), guidance in the UK recommends ‘back to sleep’ positioning for infants. Exceptions are made for babies who have respiratory difficulties; for them, side lying sleeping position is recommended because sleeping on the side makes breathing easier.

This paper by Davies et al. (2017) describes the investigation of sleep advice given to infants with a cleft palate by cleft centres in the UK. The study team got in touch with 12 cleft centres and found that in five centres the advice was to put an infant on their back in accordance with the “back to sleep” recommendation. Those centres treat babies with a cleft palate identically to non-affected babies and therefore recommend the standard back lying position. If a child started showing any breathing problems then they would be advised to sleep on their side.

In the remaining seven centres the advice was to put infants on their side. Those centres recognise that infants with a cleft palate have respiratory problems as a matter of course and therefore recommend side sleeping positing straight away.

Specialist Cleft Nurses face a clinical dilemma between adhering to standard ‘back to sleep’ guidance and responding to clinical signs of breathing problems in infants with cleft palate. Clear evidence regarding sleep position does not exist so far, and cleft centres rely on clinical judgement to identify what they believe is the most appropriate sleeping position for infants with cleft palate. Further research is needed to determine the best sleep position for an infant with cleft palate.

Download the Full Paper (PDF)

Parental Experience of Sleep-Disordered Breathing in Infants with Cleft Palate: Comparing Parental and Clinical Priorities Davies et al. 2019

Babies with cleft palate have an increased risk of breathing problems whilst asleep  due to problems with how their nose, mouth and throat have formed, meaning that they have a small airway to breathe through and their tongue falls backwards during sleep. Clinicians refer to those breathing problems during sleep as sleep-disordered breathing (SDB).  This paper describes what things about SBD that are relevant to parents, during the early weeks of caring for infants with cleft palate, and compare these with clinical outcomes identified in a systematic search of research literature.

Researchers spoke with 27 parents of children with a cleft palate about their understanding of breathing and respiratory effort in infants with cleft palate. Researchers also reviewed published literature to find out what issues within the SBD subject were reported by doctors.

Parents’ reports of their babies sleep suggests that breathing is not considered separately from their main worries of feeding and sleeping. Parents observe a sign of their child’s breathing, but these are not perceived as signs of SDB.

Parents’ decision to use side or back sleep positioning reflects their response to advice from specialists, observation of their infants’ comfort, ease of breathing, and personal experience. Outcomes, identified by doctors in published research of SDB, match parents’ concerns but are expressed in medical language and fit into distinct categories of “snoring,” “sleep,” “gas exchange,” and “apnea.”

Parents’ descriptions of sleeping and breathing in infants with CP reflect their everyday experience. It is important for doctors to know how parents think about breathing and sleeping and incorporate that into any future research studies.

Download the Full Paper (PDF)

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