<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04478201</url>
  </required_header>
  <id_info>
    <org_study_id>B00785</org_study_id>
    <nct_id>NCT04478201</nct_id>
  </id_info>
  <brief_title>Comparing the Side-lying Sleep Positioning to Back-lying in Infants With Cleft Palate</brief_title>
  <acronym>SLUMBRS2</acronym>
  <official_title>Comparing the Effectiveness of Side-lying Sleep Positioning to Back-lying at Reducing Oxygen Desaturation Resulting From Obstructive Sleep Apnoea in Infants With Cleft Palate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre for Trials Research, Cardiff University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cleft Lip and Palate Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Salisbury NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Manchester University NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The craniofacial abnormalities found in infants and children with cleft palate (CP) lead to&#xD;
      increased risk of obstructive sleep apnoea (OSA). In children and adults sleep position is&#xD;
      known to influence the patency of the airway during sleep. Altering sleep position in infants&#xD;
      with CP may offer a 'low-cost, high impact' intervention to limit the negative impacts of OSA&#xD;
      on child development.&#xD;
&#xD;
      Children with CP are at increased risk of impairment in learning, memory and cognition, with&#xD;
      OSA representing an additional risk to cognitive development. Infants with CP are at risk of&#xD;
      poor weight gain and 'failure to thrive', which can be further exacerbated by co-existing&#xD;
      OSA.&#xD;
&#xD;
      The design and conduct of the proposed randomised controlled trial will benefit from lessons&#xD;
      learned from both the feasibility and other previous studies. Investigators demonstrated that&#xD;
      existing advice given about sleep position varied significantly with some centres&#xD;
      recommending back-lying and others side-lying. Sample size calculations were based on this&#xD;
      multi-source data. Parents in the feasibility study knew that sleep position advice for&#xD;
      infants with CP changes regularly. They understood why not adhering to 'national guidance'&#xD;
      (DoH 2009, Back to Sleep) could be necessary as their infants are &quot;different to normal&#xD;
      infants&quot;.&#xD;
&#xD;
      How will this study benefit infants with cleft palate and their parents? The proposed study&#xD;
      will eliminate the current uncertainty and variability in advice provided to parents of&#xD;
      infants with CP, whilst potentially limiting the negative impact of OSA on development. This&#xD;
      work has been prioritised and received unanimous support from Cleft Lip and Palate&#xD;
      Association (CLAPA), Craniofacial Society Great Britain and Ireland (CFSGBI) and Clinical&#xD;
      Nurse Specialists. Aim.To determine the clinical effectiveness in infants with CP of&#xD;
      side-lying as compared to back-lying sleep positioning in reducing oxygen desaturation&#xD;
      resulting from OSA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this project is to determine the clinical effectiveness in infants with&#xD;
      cleft palate (CP) of side-lying as compared to back-lying sleep positioning in reducing&#xD;
      oxygen desaturation resulting from obstructive sleep apnoea (OSA). This will be achieved:&#xD;
&#xD;
        -  comparing oxygen saturation during sleep in the side- and back-lying positions at 1&#xD;
           month of age.&#xD;
&#xD;
        -  comparing sleep quality between the side-lying and back-lying groups using a parental&#xD;
           questionnaire.&#xD;
&#xD;
        -  co-developing national recommendations with parents regarding sleep position for infants&#xD;
           with CP.&#xD;
&#xD;
      A randomised controlled trial (RCT) of side-lying compared with back-lying sleep positioning&#xD;
      in reducing oxygen desaturation resulting from OSA in infants with CP. The design and conduct&#xD;
      of the study will benefit from lessons learned from the feasibility and other previous&#xD;
      studies. All parents in the feasibility study indicated strong interest to participate in&#xD;
      further studies evaluating the effects of sleep position. Infants meeting the eligibility&#xD;
      criteria will be randomised to side-lying or back-lying in a ratio 1:1 using a minimisation&#xD;
      routine incorporating a random element to reduce predictability. Minimisation factors will be&#xD;
      clinical site and syndrome suspected or indicated (yes / no). Allocations will be delivered&#xD;
      via a password-protected web-based system. The allocated position will only be used on the&#xD;
      day(s) when the infant is monitored for the study purposes. Thereafter, parents will be free&#xD;
      to revert back to the standard sleep position as advised by their cleft centre, should it be&#xD;
      different than that used for the monitoring period. All centres represented at the&#xD;
      preparatory meeting with the United Kingdom (UK) Lead Clinical Nurse Specialist group,&#xD;
      confirmed that the side-lying position was recommended in some infants at their centre,&#xD;
      irrespective of whether it was the standard advice used. As such, all centres had experience&#xD;
      of the side-lying position. It was decided not to change the specific advice that centres&#xD;
      give to parents regarding how to position the infant in a side-lying position, but any&#xD;
      standard written or verbal information would be collected by the study documents.&#xD;
&#xD;
      An internal pilot will investigate participants' opinions about their participation in the&#xD;
      study. Using bespoke questionnaires participants' experience will be assessed and it will be&#xD;
      decided how it could be improved. After 6 months questionnaire results will be analysed and&#xD;
      if necessary study amendments will be put in place to reflect participants' opinions.&#xD;
&#xD;
      Data from the feasibility study and published studies have reported estimates of the standard&#xD;
      deviation (SD) of the primary outcome ODI-4 in the side-lying infants at four weeks to range&#xD;
      from 8 to 11 units, with a higher SD observed in the back-lying group. The observed&#xD;
      difference in mean ODI-4 between the side-lying and back-lying infant cohorts was 15 units (a&#xD;
      standardised effect size of 0.91). Investigators considered a smaller but more realistic&#xD;
      difference in means of five units to be a clinically important difference (SD 10), a&#xD;
      standardised effect size of 0.5. The sample size calculation comparing two means with unequal&#xD;
      variances for the primary outcome was, therefore, based on a standardised effect size of 0.5.&#xD;
      To account for potential unequal variances in each group a variance ratio of 2 was used in&#xD;
      the calculations. To detect a difference of 0.5 standard deviation score (SDS) with 80% power&#xD;
      and alpha equal to 0.05 would require 96 infants to be monitored in each arm of the trial (a&#xD;
      total of 192 participants). Informed by the multicentre feasibility and oximetry studies the&#xD;
      sample size will be inflated to 244 participants in the RCT, to allow for potential attrition&#xD;
      of 21%.&#xD;
&#xD;
      This will follow a pre-specified and approved statistical analysis plan. The primary analysis&#xD;
      of the RCT data will use intention-to-treat. Baseline data will be analysed to assess the&#xD;
      comparability of the demographic and clinical characteristics of the participants. Data from&#xD;
      the trial arms will be compared using generalised linear models and adjusted for minimisation&#xD;
      covariates where appropriate. Estimates of treatment effect size will be reported as&#xD;
      differences in means for continuous outcomes, and risk ratios for dichotomous outcomes and&#xD;
      reported along with 95% confidence intervals. Subgroup analyses will explore the effects of&#xD;
      sleep position on infants with and without suspected associated syndromes through subgroup&#xD;
      treatment interactions, at a stricter alpha level 0.01.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 28, 2022</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygen saturation during sleep at 1 month of age</measure>
    <time_frame>1 month of age</time_frame>
    <description>Oxygen saturation during sleep at 1 month of age (expressed as 4% oxygen desaturation index, ODI-4). Oximetry is considered the mainstay of assessment of oxygenation in infants and will be the primary outcome measurement instrument. The ODI-4 represents the average number of times that oxygen saturation falls by at least 4% from baseline every hour.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SPO2 mean</measure>
    <time_frame>completed at 1 month</time_frame>
    <description>mean oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPO2 nadir</measure>
    <time_frame>completed at 1 month</time_frame>
    <description>nadir oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total sleep time</measure>
    <time_frame>completed at 1 month.</time_frame>
    <description>the proportion of total sleep time (TST) with oxygen saturation below: 97%, 95%, 90% and 80%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation during sleep at 1 month of age</measure>
    <time_frame>1 month of age</time_frame>
    <description>Oxygen saturation during sleep at 1 month of age (expressed as 3% oxygen desaturation index, ODI-3). Oximetry is considered the mainstay of assessment of oxygenation in infants and will be the primary outcome measurement instrument. The ODI-3 represents the average number of times that oxygen saturation falls by at least 3% from baseline every hour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>completed at 1 month.</time_frame>
    <description>child's weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length</measure>
    <time_frame>1 month of age</time_frame>
    <description>participant's length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Head circumference</measure>
    <time_frame>1 month of age</time_frame>
    <description>participant's head circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Adverse events.</measure>
    <time_frame>From consent for up to 2 weeks</time_frame>
    <description>Number of participants experiencing Adverse events during the trial</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">244</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Cleft Palate</condition>
  <arm_group>
    <arm_group_label>Back lying sleep position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sleep on the back</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Side lying sleep position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sleep on the side</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>back sleep positioning</intervention_name>
    <description>sleeping on the back.</description>
    <arm_group_label>Back lying sleep position</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>side sleep positioning</intervention_name>
    <description>sleeping on the side</description>
    <arm_group_label>Side lying sleep position</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants diagnosed with an isolated CP under the care of a collaborating centre&#xD;
&#xD;
          -  Infants who are 3 to 5 weeks of age when monitored&#xD;
&#xD;
          -  Parents willing to give consent and able to complete study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with associated cleft lip&#xD;
&#xD;
          -  Infants born prematurely (before 37 week gestation or up to and including 36 weeks and&#xD;
             6 days)&#xD;
&#xD;
          -  Infants with cardiorespiratory disease&#xD;
&#xD;
          -  Infants requiring an intervention to assist with breathing (nasopharyngeal airway)&#xD;
&#xD;
          -  Infants requiring an intervention to assist with feeding (nasogastric tube)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Days</minimum_age>
    <maximum_age>35 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Iain Bruce, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Manchester University NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ola Metryka</last_name>
    <phone>+44 (0)161 701 3543</phone>
    <email>slumbrs@mft.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Birmingham Women'S and Children'S Nhs Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Michelle Jones</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospitals Bristol NHS Foundation Trust</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Cathy Marsh</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cambridge University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Melanie Lindup</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Emma Blair</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Alder Hey Children'S Nhs Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Helen Robson</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital For Children Nhs Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Helen Moreland</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Manchester University Nhs Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Helen Robson</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Newcastle Upon Tyne Hospitals Nhs Foundation Trust</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Chris Couhig</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Heather Sahunta</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Salisbury Nhs Foundation Trust</name>
      <address>
        <city>Salisbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nichola Hudson</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Swansea Bay University Local Health Board</name>
      <address>
        <city>Swansea</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Michaela Rowe</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sleep</keyword>
  <keyword>Sleep position</keyword>
  <keyword>Infants with cleft palate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Palate</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04478201
org study id: B00785
nct id: NCT04478201
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The craniofacial abnormalities found in infants and children with cleft palate (CP) lead to
      increased risk of obstructive sleep apnoea (OSA). In children and adults sleep position is
      known to influence the patency of the airway during sleep. Altering sleep position in infants
      with CP may offer a 'low-cost, high impact' intervention to limit the negative impacts of OSA
      on child development.

      Children with CP are at increased risk of impairment in learning, memory and cognition, with
      OSA representing an additional risk to cognitive development. Infants with CP are at risk of
      poor weight gain and 'failure to thrive', which can be further exacerbated by co-existing
      OSA.

      The design and conduct of the proposed randomised controlled trial will benefit from lessons
      learned from both the feasibility and other previous studies. Investigators demonstrated that
      existing advice given about sleep position varied significantly with some centres
      recommending back-lying and others side-lying. Sample size calculations were based on this
      multi-source data. Parents in the feasibility study knew that sleep position advice for
      infants with CP changes regularly. They understood why not adhering to 'national guidance'
      (DoH 2009, Back to Sleep) could be necessary as their infants are "different to normal
      infants".

      How will this study benefit infants with cleft palate and their parents? The proposed study
      will eliminate the current uncertainty and variability in advice provided to parents of
      infants with CP, whilst potentially limiting the negative impact of OSA on development. This
      work has been prioritised and received unanimous support from Cleft Lip and Palate
      Association (CLAPA), Craniofacial Society Great Britain and Ireland (CFSGBI) and Clinical
      Nurse Specialists. Aim.To determine the clinical effectiveness in infants with CP of
      side-lying as compared to back-lying sleep positioning in reducing oxygen desaturation
      resulting from OSA.
The primary aim of this project is to determine the clinical effectiveness in infants with
      cleft palate (CP) of side-lying as compared to back-lying sleep positioning in reducing
      oxygen desaturation resulting from obstructive sleep apnoea (OSA). This will be achieved:

        -  comparing oxygen saturation during sleep in the side- and back-lying positions at 1
           month of age.

        -  comparing sleep quality between the side-lying and back-lying groups using a parental
           questionnaire.

        -  co-developing national recommendations with parents regarding sleep position for infants
           with CP.

      A randomised controlled trial (RCT) of side-lying compared with back-lying sleep positioning
      in reducing oxygen desaturation resulting from OSA in infants with CP. The design and conduct
      of the study will benefit from lessons learned from the feasibility and other previous
      studies. All parents in the feasibility study indicated strong interest to participate in
      further studies evaluating the effects of sleep position. Infants meeting the eligibility
      criteria will be randomised to side-lying or back-lying in a ratio 1:1 using a minimisation
      routine incorporating a random element to reduce predictability. Minimisation factors will be
      clinical site and syndrome suspected or indicated (yes / no). Allocations will be delivered
      via a password-protected web-based system. The allocated position will only be used on the
      day(s) when the infant is monitored for the study purposes. Thereafter, parents will be free
      to revert back to the standard sleep position as advised by their cleft centre, should it be
      different than that used for the monitoring period. All centres represented at the
      preparatory meeting with the United Kingdom (UK) Lead Clinical Nurse Specialist group,
      confirmed that the side-lying position was recommended in some infants at their centre,
      irrespective of whether it was the standard advice used. As such, all centres had experience
      of the side-lying position. It was decided not to change the specific advice that centres
      give to parents regarding how to position the infant in a side-lying position, but any
      standard written or verbal information would be collected by the study documents.

      An internal pilot will investigate participants' opinions about their participation in the
      study. Using bespoke questionnaires participants' experience will be assessed and it will be
      decided how it could be improved. After 6 months questionnaire results will be analysed and
      if necessary study amendments will be put in place to reflect participants' opinions.

      Data from the feasibility study and published studies have reported estimates of the standard
      deviation (SD) of the primary outcome ODI-4 in the side-lying infants at four weeks to range
      from 8 to 11 units, with a higher SD observed in the back-lying group. The observed
      difference in mean ODI-4 between the side-lying and back-lying infant cohorts was 15 units (a
      standardised effect size of 0.91). Investigators considered a smaller but more realistic
      difference in means of five units to be a clinically important difference (SD 10), a
      standardised effect size of 0.5. The sample size calculation comparing two means with unequal
      variances for the primary outcome was, therefore, based on a standardised effect size of 0.5.
      To account for potential unequal variances in each group a variance ratio of 2 was used in
      the calculations. To detect a difference of 0.5 standard deviation score (SDS) with 80% power
      and alpha equal to 0.05 would require 96 infants to be monitored in each arm of the trial (a
      total of 192 participants). Informed by the multicentre feasibility and oximetry studies the
      sample size will be inflated to 244 participants in the RCT, to allow for potential attrition
      of 21%.

      This will follow a pre-specified and approved statistical analysis plan. The primary analysis
      of the RCT data will use intention-to-treat. Baseline data will be analysed to assess the
      comparability of the demographic and clinical characteristics of the participants. Data from
      the trial arms will be compared using generalised linear models and adjusted for minimisation
      covariates where appropriate. Estimates of treatment effect size will be reported as
      differences in means for continuous outcomes, and risk ratios for dichotomous outcomes and
      reported along with 95% confidence intervals. Subgroup analyses will explore the effects of
      sleep position on infants with and without suspected associated syndromes through subgroup
      treatment interactions, at a stricter alpha level 0.01.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Oxygen saturation during sleep at 1 month of age
time frame: 1 month of age
description: Oxygen saturation during sleep at 1 month of age (expressed as 4% oxygen desaturation index, ODI-4). Oximetry is considered the mainstay of assessment of oxygenation in infants and will be the primary outcome measurement instrument. The ODI-4 represents the average number of times that oxygen saturation falls by at least 4% from baseline every hour.
measure: SPO2 mean
time frame: completed at 1 month
description: mean oxygen saturation
measure: SPO2 nadir
time frame: completed at 1 month
description: nadir oxygen saturation
measure: Total sleep time
time frame: completed at 1 month.
description: the proportion of total sleep time (TST) with oxygen saturation below: 97%, 95%, 90% and 80%
measure: Oxygen saturation during sleep at 1 month of age
time frame: 1 month of age
description: Oxygen saturation during sleep at 1 month of age (expressed as 3% oxygen desaturation index, ODI-3). Oximetry is considered the mainstay of assessment of oxygenation in infants and will be the primary outcome measurement instrument. The ODI-3 represents the average number of times that oxygen saturation falls by at least 3% from baseline every hour.
measure: Weight
time frame: completed at 1 month.
description: child's weight
measure: Length
time frame: 1 month of age
description: participant's length
measure: Head circumference
time frame: 1 month of age
description: participant's head circumference
measure: Number of participants with Adverse events.
time frame: From consent for up to 2 weeks
description: Number of participants experiencing Adverse events during the trial
arm group label: Back lying sleep position
arm group type: Experimental
description: sleep on the back
arm group label: Side lying sleep position
arm group type: Experimental
description: sleep on the side
intervention type: Other
intervention name: back sleep positioning
description: sleeping on the back.
arm group label: Back lying sleep position
intervention type: Other
intervention name: side sleep positioning
description: sleeping on the side
arm group label: Side lying sleep position
criteria: 
gender: All
minimum age: 21 Days
maximum age: 35 Days
healthy volunteers: No
last name: Iain Bruce, Prof
role: Study Director
affiliation: Manchester University NHS Foundation Trust
last name: Ola Metryka
phone: +44 (0)161 701 3543
email: slumbrs@mft.nhs.uk
facility: 
status: Not yet recruiting
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status: Not yet recruiting
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status: Recruiting
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country: United Kingdom
responsible party type: Sponsor
mesh term: Cleft Palate
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No