xml: <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/NCT05961904</url>
    </required_header>
    <id_info>
      <org_study_id>Ozgul2</org_study_id>
      <nct_id>NCT05961904</nct_id>
    </id_info>
    <brief_title>Impact of Breast Milk on Cortical Pain Response in Newborns</brief_title>
    <official_title>Impact of Breast Milk on Cortical Pain Response in Newborns During the Heel Prick Procedure: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Medeniyet University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Medeniyet 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>
        Background:Newborns are exposed to painful procedures for many different reasons in the first&#xD;
        days of their life. If pain is not relieved effectively in these newborns, neurodevelopmental&#xD;
        and behavioral problems may occur in the short- and long-term.&#xD;
  &#xD;
        Objective:This study is aimed to investigate the effects of breast milk on cortical pain&#xD;
        response and behavioral response in newborns during heel-prick procedure.&#xD;
  &#xD;
        Design: A prospective, randomized controlled trial was conducted on newborns born in a&#xD;
        university hospital. Healthy-term newborns, undergoing heel blood sampling for newborn&#xD;
        screening, were enrolled in the study. Infants were randomly assigned to study group with&#xD;
        receive orally 2 ml breast milk (n=45) or a control group with no intervention (n=45) before&#xD;
        the heel prick. A near-infrared spectroscopy device was used to monitor regional cerebral&#xD;
        oxygen saturation (rScO2), while neonatal pain expression was assessed by Neonatal Pain,&#xD;
        Agitation, and Sedation Scale (N-PASS). The rScO2 measure was the primary outcome, while the&#xD;
        N-PASS score, heart rate, SaO2, and crying time were the secondary outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        During the first few days of life, newborns are exposed to painful and stressful&#xD;
        procedures.1, 2 One of these is the metabolic disease screening test using the heel-prick&#xD;
        procedures.3, 4 Newborn screening is crucial to detect several congenital genetic and&#xD;
        metabolic disorders at an early stage for the earliest possible recognition and management of&#xD;
        affected newborns and to prevent morbidity, mortality, and disabilities associated with&#xD;
        inherited metabolic disorders5. Pain induced by these procedures is ineffectively prevented&#xD;
        or inadequately treated1. Consequently, this may have short- and long-term negative effects&#xD;
        on the pain response and neurodevelopmental outcomes.6, 7, 8 Thus, effectively identifying,&#xD;
        assessing, and managing neonatal pain are crucial to minimizing its impact on the&#xD;
        intermediate- and long-term outcomes in newborns.2, 9 Near-infrared spectroscopy (NIRS) is a&#xD;
        noninvasive technique widely used in neonatal pain research to measure functional activation&#xD;
        of the cortex.20, 21, 22, 23 NIRS has revealed that blood sampling can activate the neonatal&#xD;
        somatosensory20, 21, motor24, and prefrontal22 areas starting at the 25th week of&#xD;
        postmenstrual age. Pain increases oxygen consumption with changes occurring in the primary&#xD;
        somatosensory cortex on the brain surface.25, 26 Additionally, the relationship between the&#xD;
        total Premature Infant Pain Profile (PIPP)27 score and hemodynamic response has been&#xD;
        evaluated.&#xD;
  &#xD;
        Among the analgesics studied for neonatal pain, breast milk is a natural substance beneficial&#xD;
        and nutritious for infants.32 Whether breast milk administration alters cortical brain&#xD;
        activation in neonates is presently unclear. Therefore, we conducted a trial to assess&#xD;
        whether breast milk can relieve cortical pain during a painful metabolic disease screening&#xD;
        procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2021</start_date>
    <completion_date type="Actual">September 15, 2021</completion_date>
    <primary_completion_date type="Actual">August 30, 2021</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>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The rScO2 measure was the primary outcome.</measure>
      <time_frame>2 months</time_frame>
      <description>A near-infrared spectroscopy device was used to monitor regional cerebral oxygen saturation (rScO2). Pain increases oxygen consumption with changes occurring in the rScO2 measure.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Neonatal Pain, Agitation, and Sedation scale</measure>
      <time_frame>2 months</time_frame>
      <description>The mean of the Neonatal Pain, Agitation, and Sedation score (A score &gt;+3 indicates pain)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">90</enrollment>
    <condition>Pain Management</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Study group with receive orally breast milk</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>no intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Breastmilk</intervention_name>
      <description>Study group with receive orally 2 ml breast milk before the heel prick.</description>
      <arm_group_label>Study group</arm_group_label>
      <other_name>Human milk</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The inclusion criteria selected neonates born after 37 weeks of gestation, postnatal&#xD;
               age more than 24 hours (h), absence of congenital malformations, ongoing intubation,&#xD;
               and mechanical ventilation, who had not received analgesic, anesthetic, or sedative&#xD;
               drugs.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Neonates born before 37 weeks of gestation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Days</minimum_age>
      <maximum_age>3 Days</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ozgul Bulut</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcın City Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcın City Hospital</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
      <investigator_full_name>Ozgul Bulut</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Analgesia</keyword>
    <keyword>breastmilk</keyword>
    <keyword>cortical pain response</keyword>
    <keyword>heal prick procedure</keyword>
    <keyword>Near-infrared spectroscopy</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05961904
  org study id: Ozgul2
  nct id: NCT05961904
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background:Newborns are exposed to painful procedures for many different reasons in the first
        days of their life. If pain is not relieved effectively in these newborns, neurodevelopmental
        and behavioral problems may occur in the short- and long-term.
  
        Objective:This study is aimed to investigate the effects of breast milk on cortical pain
        response and behavioral response in newborns during heel-prick procedure.
  
        Design: A prospective, randomized controlled trial was conducted on newborns born in a
        university hospital. Healthy-term newborns, undergoing heel blood sampling for newborn
        screening, were enrolled in the study. Infants were randomly assigned to study group with
        receive orally 2 ml breast milk (n=45) or a control group with no intervention (n=45) before
        the heel prick. A near-infrared spectroscopy device was used to monitor regional cerebral
        oxygen saturation (rScO2), while neonatal pain expression was assessed by Neonatal Pain,
        Agitation, and Sedation Scale (N-PASS). The rScO2 measure was the primary outcome, while the
        N-PASS score, heart rate, SaO2, and crying time were the secondary outcomes.
  During the first few days of life, newborns are exposed to painful and stressful
        procedures.1, 2 One of these is the metabolic disease screening test using the heel-prick
        procedures.3, 4 Newborn screening is crucial to detect several congenital genetic and
        metabolic disorders at an early stage for the earliest possible recognition and management of
        affected newborns and to prevent morbidity, mortality, and disabilities associated with
        inherited metabolic disorders5. Pain induced by these procedures is ineffectively prevented
        or inadequately treated1. Consequently, this may have short- and long-term negative effects
        on the pain response and neurodevelopmental outcomes.6, 7, 8 Thus, effectively identifying,
        assessing, and managing neonatal pain are crucial to minimizing its impact on the
        intermediate- and long-term outcomes in newborns.2, 9 Near-infrared spectroscopy (NIRS) is a
        noninvasive technique widely used in neonatal pain research to measure functional activation
        of the cortex.20, 21, 22, 23 NIRS has revealed that blood sampling can activate the neonatal
        somatosensory20, 21, motor24, and prefrontal22 areas starting at the 25th week of
        postmenstrual age. Pain increases oxygen consumption with changes occurring in the primary
        somatosensory cortex on the brain surface.25, 26 Additionally, the relationship between the
        total Premature Infant Pain Profile (PIPP)27 score and hemodynamic response has been
        evaluated.
  
        Among the analgesics studied for neonatal pain, breast milk is a natural substance beneficial
        and nutritious for infants.32 Whether breast milk administration alters cortical brain
        activation in neonates is presently unclear. Therefore, we conducted a trial to assess
        whether breast milk can relieve cortical pain during a painful metabolic disease screening
        procedure.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: The rScO2 measure was the primary outcome.
  time frame: 2 months
  description: A near-infrared spectroscopy device was used to monitor regional cerebral oxygen saturation (rScO2). Pain increases oxygen consumption with changes occurring in the rScO2 measure.
  measure: The Neonatal Pain, Agitation, and Sedation scale
  time frame: 2 months
  description: The mean of the Neonatal Pain, Agitation, and Sedation score (A score >+3 indicates pain)
  arm group label: Study group
  arm group type: Experimental
  description: Study group with receive orally breast milk
  arm group label: Control group
  arm group type: No Intervention
  description: no intervention
  intervention type: Other
  intervention name: Breastmilk
  description: Study group with receive orally 2 ml breast milk before the heel prick.
  arm group label: Study group
  other name: Human milk
  criteria: 
  gender: All
  minimum age: 2 Days
  maximum age: 3 Days
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ozgul Bulut
  role: Principal Investigator
  affiliation: Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcın City Hospital
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medeniyet University
  investigator full name: Ozgul Bulut
  investigator title: Principal Investigator
  sharing ipd: No