<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/NCT04463511</url>
  </required_header>
  <id_info>
    <org_study_id>APOLLO_PB_BCC</org_study_id>
    <nct_id>NCT04463511</nct_id>
  </id_info>
  <brief_title>Placing Preterm Infants in Polyethylene Bags Immediately After Birth</brief_title>
  <official_title>Placing Preterm Infants in Polyethylene Bags Immediately After Birth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College Dublin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College Dublin</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>
      Primary objective: To determine if placing preterm infants in a polyethylene bag (PB)&#xD;
      immediately after birth, before the umbilical cord is clamped, will increase the number of&#xD;
      preterm infants with a normal temperature on admission to the Neonatal Intensive Care Unit&#xD;
      (NICU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Newly born preterm infants that develop abnormal temperature after birth have higher&#xD;
      morbidity and mortality. Placing infants &lt; 32 weeks' gestation in a polyethylene bag (PB) in&#xD;
      the delivery room (DR) reduces the rate of hypothermia on admission to the Neonatal Intensive&#xD;
      Care Unit (NICU). Since 2012, the rate of admission hypothermia in preterm infants, placed in&#xD;
      a PB in the DR at the National Maternity Hospital (NMH), has increased significantly. This&#xD;
      may be as a result of heat loss while the infant remains attached to the cord.&#xD;
&#xD;
      Our primary objective is to determine if placing preterm infants in a PB immediately after&#xD;
      birth, before the umbilical cord is clamped will increase the number of preterm infants with&#xD;
      a normal temperature on admission to the NICU.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</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>
    <intervention_model_description>Single-centre randomised controlled trail</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>In the delivery room, the infant is randomised to application of a polyethylene bag before or after cord clamping. Neither the delivery room care provider nor the investigator are blinded to the group assignment. When the infant is stable, they are be transferred from the delivery room to the neonatal unit. The outcome assessor is the admitting nurse in the neonatal unit who will be blinded to the group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Temperature on admission to the Neonatal Intensive Care Unit (NICU)</measure>
    <time_frame>The primary outcome measure will be determined on admission to the NICU, before the infant is removed from the transport incubator (&lt; 90minutes of life)</time_frame>
    <description>Rectal temperature recorded upon arrival to the NICU, while the infant is in the transport incubator. (measured in degrees celsius)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory support in the DR</measure>
    <time_frame>Within 2 hours of birth</time_frame>
    <description>Type and duration of respiratory support in the DR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5 minute Apgar</measure>
    <time_frame>Within 2 hours of birth</time_frame>
    <description>Scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>External cardiac massage in the delivery room</measure>
    <time_frame>Within 2 hours of birth</time_frame>
    <description>Yes/ No, Duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant temperature recordings in the delivery room</measure>
    <time_frame>Within 2 hours of birth</time_frame>
    <description>Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Axillary temperature on admission to the NICU</measure>
    <time_frame>Between 0-2 hours of life</time_frame>
    <description>Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature 1 hour after admission</measure>
    <time_frame>Between 0-2 hours of life</time_frame>
    <description>Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central catheter placement in first 24 hours</measure>
    <time_frame>Between 0-24 hours of life</time_frame>
    <description>Yes/no. Type and location of catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation and mechanical ventilation</measure>
    <time_frame>Term corrected gestation age or hospital discharge (&lt;17 weeks)</time_frame>
    <description>Yes/no, type and duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Distress Syndrome</measure>
    <time_frame>Between 0-24 hours of life</time_frame>
    <description>Yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-invasive ventilation (NIV) on the first day of life (24 hours)</measure>
    <time_frame>Between 0-24 hours of life</time_frame>
    <description>Yes/ no, type of NIV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surfactant administration</measure>
    <time_frame>Day 1 - 7 of life</time_frame>
    <description>Yes/ no, route of administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pneumothorax requiring drainage</measure>
    <time_frame>Term corrected gestation age or hospital discharge (&lt;17 weeks)</time_frame>
    <description>Yes/ no, needle aspiration or definitive chest drain or both</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary haemorrhage</measure>
    <time_frame>Term corrected gestation age or hospital discharge (&lt;17 weeks)</time_frame>
    <description>Yes/ no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypotension requiring inotropes</measure>
    <time_frame>Term corrected gestation age or hospital discharge (&lt;17 weeks)</time_frame>
    <description>Yes/ no, inotropes, duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraventricular haemorrhage</measure>
    <time_frame>Term corrected gestation age or hospital discharge (&lt;17 weeks)</time_frame>
    <description>Papile classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periventricular leukomalacia</measure>
    <time_frame>Term corrected gestation age or hospital discharge (&lt;17 weeks)</time_frame>
    <description>Yes/ no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Necrotising enterocolitis</measure>
    <time_frame>Term corrected gestation age or hospital discharge (&lt;17 weeks)</time_frame>
    <description>Bell's staging criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sepsis - early onset</measure>
    <time_frame>Between 0-72 hours of life</time_frame>
    <description>Yes/ no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sepsis - late onset</measure>
    <time_frame>After 72 hours of life until term corrected or hospital discharge (maximum 16 weeks)</time_frame>
    <description>Yes/ no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinopathy of prematurity requiring treatment</measure>
    <time_frame>Term corrected gestation age or hospital discharge (&lt;17 weeks)</time_frame>
    <description>Yes/ no, treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen requirement at 36 weeks corrected gestational age</measure>
    <time_frame>36 weeks corrected gestational age</time_frame>
    <description>Yes/ no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death before discharge from hospital</measure>
    <time_frame>Term corrected gestation age or hospital discharge (&lt;17 weeks)</time_frame>
    <description>Yes/ no</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">194</enrollment>
  <condition>Newborn</condition>
  <condition>Infant</condition>
  <condition>Hypothermia</condition>
  <condition>Premature</condition>
  <arm_group>
    <arm_group_label>PB BCC: Polyethylene Bag Before Cord Clamping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immediately after delivery, while still attached to placental circulation, infants will be placed in a PB. After the cord has been clamped and cut, the infant will be transferred to the resuscitaire for ongoing care. In the case of caesarean section a sterile bag will be used and prepared observing sterile techniques. A member of the neonatal team donned in sterile gown and gloves will assist the obstetrician in placing the infant in the PB.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PB ACC: Polyethylene Bag After Cord Clamping</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Infants will not be placed in a PB immediately after birth. After the cord has been clamped and cut, the infant will be transferred to the resuscitaire where they will be placed in a PB.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Polyethylene bag before the umbilical cord is clamped</intervention_name>
    <description>11&quot; x 16&quot; (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)</description>
    <arm_group_label>PB BCC: Polyethylene Bag Before Cord Clamping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Infants who are inborn at the National Maternity Hospital at &lt; 32 (up to 31+6) weeks'&#xD;
        gestation by best obstetric estimate will be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with a large abdominal wall or neural tube defects&#xD;
&#xD;
          -  Infants with an imperforate anus&#xD;
&#xD;
          -  Infants to whom resuscitative measures are not initiated in the DR&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>32 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa K McCarthy, MB BCh BAO</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Maternity Hospital / University College Dublin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa K McCarthy, MB BCh BAO</last_name>
    <phone>+3531637310</phone>
    <phone_ext>3410</phone_ext>
    <email>lmccarthy@nmh.ie</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emma A Dunne, MB BCh BAO</last_name>
    <phone>+35316373100</phone>
    <phone_ext>3410</phone_ext>
    <email>emma.dunne9@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Maternity Hospital</name>
      <address>
        <city>Dublin</city>
        <state>Dubiln</state>
        <zip>2</zip>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa K McCarthy, MB BCh BAO PhD</last_name>
      <phone>016373100</phone>
      <email>lmccarthy@nmh.ie</email>
    </contact>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <results_reference>
    <citation>McCall EM, Alderdice F, Halliday HL, Vohra S, Johnston L. Interventions to prevent hypothermia at birth in preterm and/or low birth weight infants. Cochrane Database Syst Rev. 2018 Feb 12;2(2):CD004210. doi: 10.1002/14651858.CD004210.pub5.</citation>
    <PMID>29431872</PMID>
  </results_reference>
  <results_reference>
    <citation>Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12.</citation>
    <PMID>17296783</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cord clamping</keyword>
  <keyword>hypothermia</keyword>
  <keyword>hyperthermia</keyword>
  <keyword>polyethylene bag</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</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/NCT04463511
org study id: APOLLO_PB_BCC
nct id: NCT04463511
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary objective: To determine if placing preterm infants in a polyethylene bag (PB)
      immediately after birth, before the umbilical cord is clamped, will increase the number of
      preterm infants with a normal temperature on admission to the Neonatal Intensive Care Unit
      (NICU).
Newly born preterm infants that develop abnormal temperature after birth have higher
      morbidity and mortality. Placing infants < 32 weeks' gestation in a polyethylene bag (PB) in
      the delivery room (DR) reduces the rate of hypothermia on admission to the Neonatal Intensive
      Care Unit (NICU). Since 2012, the rate of admission hypothermia in preterm infants, placed in
      a PB in the DR at the National Maternity Hospital (NMH), has increased significantly. This
      may be as a result of heat loss while the infant remains attached to the cord.

      Our primary objective is to determine if placing preterm infants in a PB immediately after
      birth, before the umbilical cord is clamped will increase the number of preterm infants with
      a normal temperature on admission to the NICU.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single-centre randomised controlled trail
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: In the delivery room, the infant is randomised to application of a polyethylene bag before or after cord clamping. Neither the delivery room care provider nor the investigator are blinded to the group assignment. When the infant is stable, they are be transferred from the delivery room to the neonatal unit. The outcome assessor is the admitting nurse in the neonatal unit who will be blinded to the group assignment.
measure: Temperature on admission to the Neonatal Intensive Care Unit (NICU)
time frame: The primary outcome measure will be determined on admission to the NICU, before the infant is removed from the transport incubator (< 90minutes of life)
description: Rectal temperature recorded upon arrival to the NICU, while the infant is in the transport incubator. (measured in degrees celsius)
measure: Respiratory support in the DR
time frame: Within 2 hours of birth
description: Type and duration of respiratory support in the DR
measure: 5 minute Apgar
time frame: Within 2 hours of birth
description: Scale (0-10)
measure: External cardiac massage in the delivery room
time frame: Within 2 hours of birth
description: Yes/ No, Duration
measure: Infant temperature recordings in the delivery room
time frame: Within 2 hours of birth
description: Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
measure: Axillary temperature on admission to the NICU
time frame: Between 0-2 hours of life
description: Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
measure: Temperature 1 hour after admission
time frame: Between 0-2 hours of life
description: Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
measure: Central catheter placement in first 24 hours
time frame: Between 0-24 hours of life
description: Yes/no. Type and location of catheter
measure: Intubation and mechanical ventilation
time frame: Term corrected gestation age or hospital discharge (<17 weeks)
description: Yes/no, type and duration
measure: Respiratory Distress Syndrome
time frame: Between 0-24 hours of life
description: Yes/no
measure: Non-invasive ventilation (NIV) on the first day of life (24 hours)
time frame: Between 0-24 hours of life
description: Yes/ no, type of NIV
measure: Surfactant administration
time frame: Day 1 - 7 of life
description: Yes/ no, route of administration
measure: Pneumothorax requiring drainage
time frame: Term corrected gestation age or hospital discharge (<17 weeks)
description: Yes/ no, needle aspiration or definitive chest drain or both
measure: Pulmonary haemorrhage
time frame: Term corrected gestation age or hospital discharge (<17 weeks)
description: Yes/ no
measure: Hypotension requiring inotropes
time frame: Term corrected gestation age or hospital discharge (<17 weeks)
description: Yes/ no, inotropes, duration
measure: Intraventricular haemorrhage
time frame: Term corrected gestation age or hospital discharge (<17 weeks)
description: Papile classification
measure: Periventricular leukomalacia
time frame: Term corrected gestation age or hospital discharge (<17 weeks)
description: Yes/ no
measure: Necrotising enterocolitis
time frame: Term corrected gestation age or hospital discharge (<17 weeks)
description: Bell's staging criteria
measure: Sepsis - early onset
time frame: Between 0-72 hours of life
description: Yes/ no
measure: Sepsis - late onset
time frame: After 72 hours of life until term corrected or hospital discharge (maximum 16 weeks)
description: Yes/ no
measure: Retinopathy of prematurity requiring treatment
time frame: Term corrected gestation age or hospital discharge (<17 weeks)
description: Yes/ no, treatment
measure: Oxygen requirement at 36 weeks corrected gestational age
time frame: 36 weeks corrected gestational age
description: Yes/ no
measure: Death before discharge from hospital
time frame: Term corrected gestation age or hospital discharge (<17 weeks)
description: Yes/ no
arm group label: PB BCC: Polyethylene Bag Before Cord Clamping
arm group type: Experimental
description: Immediately after delivery, while still attached to placental circulation, infants will be placed in a PB. After the cord has been clamped and cut, the infant will be transferred to the resuscitaire for ongoing care. In the case of caesarean section a sterile bag will be used and prepared observing sterile techniques. A member of the neonatal team donned in sterile gown and gloves will assist the obstetrician in placing the infant in the PB.
arm group label: PB ACC: Polyethylene Bag After Cord Clamping
arm group type: No Intervention
description: Infants will not be placed in a PB immediately after birth. After the cord has been clamped and cut, the infant will be transferred to the resuscitaire where they will be placed in a PB.
intervention type: Other
intervention name: Polyethylene bag before the umbilical cord is clamped
description: 11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)
arm group label: PB BCC: Polyethylene Bag Before Cord Clamping
criteria: 
gender: All
minimum age: N/A
maximum age: 32 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Lisa K McCarthy, MB BCh BAO
role: Principal Investigator
affiliation: National Maternity Hospital / University College Dublin
last name: Lisa K McCarthy, MB BCh BAO
phone: +3531637310
phone ext: 3410
email: lmccarthy@nmh.ie
last name: Emma A Dunne, MB BCh BAO
phone: +35316373100
phone ext: 3410
email: emma.dunne9@gmail.com
facility: 
status: Recruiting
contact: 
country: Ireland
citation: McCall EM, Alderdice F, Halliday HL, Vohra S, Johnston L. Interventions to prevent hypothermia at birth in preterm and/or low birth weight infants. Cochrane Database Syst Rev. 2018 Feb 12;2(2):CD004210. doi: 10.1002/14651858.CD004210.pub5.
PMID: 29431872
citation: Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12.
PMID: 17296783
responsible party type: Sponsor
mesh term: Hypothermia
sharing ipd: No