<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/NCT03836326</url>
  </required_header>
  <id_info>
    <org_study_id>6023834</org_study_id>
    <nct_id>NCT03836326</nct_id>
  </id_info>
  <brief_title>A Parent Administered Sensorimotor Intervention and Developmental Outcome of Preterm Infants</brief_title>
  <official_title>Developmental Outcome of Preterm Infants Enrolled in a Randomized Clinical of a Parent Administered Sensorimotor Intervention in the Neonatal Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Sandra Fucile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen's University</source>
  <oversight_info>
    <has_dmc>No</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>
      Advances in medical technologies over the last three decades have increased survival rates in&#xD;
      infants born preterm . Preterm infants are at high risk of developing developmental delays.&#xD;
      Implementation of effective strategies aimed at improving the developmental outcome of&#xD;
      preterm born children is critical.&#xD;
&#xD;
      The proposed study is designed to evaluate the addition of a parent administered sensorimotor&#xD;
      program on the developmental outcome of infants who are born preterm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children who are born prematurely are at a higher risk of developing developmental delays&#xD;
      than children born at term. Early experiences in the neonatal intensive care unit (NICU) can&#xD;
      influence developmental outcomes. Sensorimotor interventions as well as parental engagement&#xD;
      have been designed with the aim of improving the development of children born preterm.&#xD;
      Substantial evidence supports the benefits of each intervention on improving developmental&#xD;
      outcomes. However, there remains a significant gap in the literature on the efficacy of a&#xD;
      parent administered sensorimotor intervention (PASI) program in the NICU on infant's&#xD;
      development. The proposed study is designed to evaluate the potential benefits of such a&#xD;
      program on infant's development. A randomized block clinical trial will be performed.&#xD;
&#xD;
      A total of 84 preterm infants (&lt; 34 weeks gestation) will be recruited and randomized.&#xD;
      Infants in the experimental group will receive the sensorimotor program,consisting of tactile&#xD;
      (whole body) and oral input for 15 minutes, one time per day, for 10 days. Infants in the&#xD;
      control group will receive standard care. The following outcomes will be monitored time to&#xD;
      attainment of complete oral feeds (primary outcome), rate of weight gain, length of&#xD;
      hospitalization, and developmental outcomes at 36 weeks corrected gestational age and at 4,&#xD;
      8, 12, 18 and 24 months corrected age. Results from this study will provide us with further&#xD;
      knowledge on the impact of sensorimotor intervention on infants' developmental outcome as&#xD;
      well as the effect of active parental involvement on infants' development. Provision of a&#xD;
      PASI program is a safe and low cost effective intervention that may increase the development&#xD;
      and quality of life of preterm born children and their family.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Anticipated">July 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2023</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized clinical trail</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>A prospective randomized block clinical trial will be conducted. Infants will be randomized into experimental (PASI program) and control (standard care program) groups using a block size of four per arm, where the first set of four participants will be in the experimental group and once they have completed the intervention, the subsequent set of four participants will be in the control group. A randomized block design was selected because the treatment assignment cannot be masked. The block randomization procedure will reduce the potential for contamination between groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Attainment of independent oral feeds</measure>
    <time_frame>3 years</time_frame>
    <description>Number of days to transition from complete tube to complete oral feeds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight gain</measure>
    <time_frame>3 years</time_frame>
    <description>Weight gain velocity from start of study until hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>3 years</time_frame>
    <description>Number of days from birth to discharge home</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test of infant motor performance</measure>
    <time_frame>3 years</time_frame>
    <description>A standardized assessment measuring postural control and motor function in infants from 32 weeks gestation to 4 months corrected gestational age. Total raw scores range from 0-142, higher scores represent better motor function.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Premature Infant</condition>
  <condition>Developmental Delay</condition>
  <arm_group>
    <arm_group_label>Sensorimotor intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Is a 15-minute intervention consisting of tactile (i.e., stroking the whole body) and oral input (i.e., stroking the oral structures) for 15 minutes duration. The program will start 24 hours after nasal continuous positive airway pressure (NCPAP) is discontinued and 24 hours after 80 ml/kg/day of enteral feeds are tolerated. The program will be administered once a day for 10 days, within a 14-day period. The parents will perform all the interventions in the NICU. The infants will remain in the isolette for the duration of the program. This intervention does not involve any drugs or medical procedures. It is an intervention commonly used by occupational and physical therapists in the neonatal intensive care unit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Infants in the control group will receive standard care only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sensorimotor intervention</intervention_name>
    <description>Sensorimotor intervention involves, stroking of the whole body including the oral structures, trunk and limbs. This intervention does not involve any drugs or medical procedure.</description>
    <arm_group_label>Sensorimotor intervention</arm_group_label>
    <other_name>Supplemental stimulation</other_name>
    <other_name>Sensory input</other_name>
    <other_name>Tactile input</other_name>
    <other_name>Oral input</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Routine care provided by health professionals in the NICU</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants born &lt; 34 weeks gestation&#xD;
&#xD;
          -  Infants whose parent (s) intend on visiting regularly (&gt; 5 days)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants born with a metabolic disorder or congenital abnormality&#xD;
&#xD;
          -  Infants whose parents are unable to participate due to cognitive, physical or social&#xD;
             issues.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>34 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra Fucile, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sandra Fucile, PhD</last_name>
    <phone>613-548-6046</phone>
    <phone_ext>2179</phone_ext>
    <email>sandra.fucile@queensu.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kimberly Dow, MD</last_name>
    <phone>613-548-6046</phone>
    <email>kdow@queensu.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kingston Health Sciences Center</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>k7l2v7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra Fucile, PhD</last_name>
      <phone>613-548-9999</phone>
      <phone_ext>2179</phone_ext>
      <email>sandra.fucile@queensu.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>September 6, 2022</last_update_submitted>
  <last_update_submitted_qc>September 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University</investigator_affiliation>
    <investigator_full_name>Dr. Sandra Fucile</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>Prematurity</keyword>
  <keyword>Development</keyword>
  <keyword>Parental engagement</keyword>
  <keyword>Parental satisfaction</keyword>
  <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/NCT03836326
org study id: 6023834
nct id: NCT03836326
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Advances in medical technologies over the last three decades have increased survival rates in
      infants born preterm . Preterm infants are at high risk of developing developmental delays.
      Implementation of effective strategies aimed at improving the developmental outcome of
      preterm born children is critical.

      The proposed study is designed to evaluate the addition of a parent administered sensorimotor
      program on the developmental outcome of infants who are born preterm.
Children who are born prematurely are at a higher risk of developing developmental delays
      than children born at term. Early experiences in the neonatal intensive care unit (NICU) can
      influence developmental outcomes. Sensorimotor interventions as well as parental engagement
      have been designed with the aim of improving the development of children born preterm.
      Substantial evidence supports the benefits of each intervention on improving developmental
      outcomes. However, there remains a significant gap in the literature on the efficacy of a
      parent administered sensorimotor intervention (PASI) program in the NICU on infant's
      development. The proposed study is designed to evaluate the potential benefits of such a
      program on infant's development. A randomized block clinical trial will be performed.

      A total of 84 preterm infants (< 34 weeks gestation) will be recruited and randomized.
      Infants in the experimental group will receive the sensorimotor program,consisting of tactile
      (whole body) and oral input for 15 minutes, one time per day, for 10 days. Infants in the
      control group will receive standard care. The following outcomes will be monitored time to
      attainment of complete oral feeds (primary outcome), rate of weight gain, length of
      hospitalization, and developmental outcomes at 36 weeks corrected gestational age and at 4,
      8, 12, 18 and 24 months corrected age. Results from this study will provide us with further
      knowledge on the impact of sensorimotor intervention on infants' developmental outcome as
      well as the effect of active parental involvement on infants' development. Provision of a
      PASI program is a safe and low cost effective intervention that may increase the development
      and quality of life of preterm born children and their family.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized clinical trail
primary purpose: Prevention
masking: None (Open Label)
masking description: A prospective randomized block clinical trial will be conducted. Infants will be randomized into experimental (PASI program) and control (standard care program) groups using a block size of four per arm, where the first set of four participants will be in the experimental group and once they have completed the intervention, the subsequent set of four participants will be in the control group. A randomized block design was selected because the treatment assignment cannot be masked. The block randomization procedure will reduce the potential for contamination between groups.
measure: Attainment of independent oral feeds
time frame: 3 years
description: Number of days to transition from complete tube to complete oral feeds.
measure: Weight gain
time frame: 3 years
description: Weight gain velocity from start of study until hospital discharge
measure: Length of hospital stay
time frame: 3 years
description: Number of days from birth to discharge home
measure: Test of infant motor performance
time frame: 3 years
description: A standardized assessment measuring postural control and motor function in infants from 32 weeks gestation to 4 months corrected gestational age. Total raw scores range from 0-142, higher scores represent better motor function.
arm group label: Sensorimotor intervention
arm group type: Experimental
description: Is a 15-minute intervention consisting of tactile (i.e., stroking the whole body) and oral input (i.e., stroking the oral structures) for 15 minutes duration. The program will start 24 hours after nasal continuous positive airway pressure (NCPAP) is discontinued and 24 hours after 80 ml/kg/day of enteral feeds are tolerated. The program will be administered once a day for 10 days, within a 14-day period. The parents will perform all the interventions in the NICU. The infants will remain in the isolette for the duration of the program. This intervention does not involve any drugs or medical procedures. It is an intervention commonly used by occupational and physical therapists in the neonatal intensive care unit.
arm group label: Control
arm group type: Other
description: Infants in the control group will receive standard care only.
intervention type: Other
intervention name: Sensorimotor intervention
description: Sensorimotor intervention involves, stroking of the whole body including the oral structures, trunk and limbs. This intervention does not involve any drugs or medical procedure.
arm group label: Sensorimotor intervention
other name: Supplemental stimulation
other name: Sensory input
other name: Tactile input
other name: Oral input
intervention type: Other
intervention name: Control
description: Routine care provided by health professionals in the NICU
arm group label: Control
criteria: 
gender: All
minimum age: N/A
maximum age: 34 Weeks
healthy volunteers: No
last name: Sandra Fucile, PhD
role: Principal Investigator
affiliation: Queen's University
last name: Sandra Fucile, PhD
phone: 613-548-6046
phone ext: 2179
email: sandra.fucile@queensu.ca
last name: Kimberly Dow, MD
phone: 613-548-6046
email: kdow@queensu.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Queen's University
investigator full name: Dr. Sandra Fucile
investigator title: PI
sharing ipd: No