<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/NCT04429750</url>
  </required_header>
  <id_info>
    <org_study_id>2018_94</org_study_id>
    <secondary_id>2019-A01030-57</secondary_id>
    <secondary_id>PHRC-18-0234</secondary_id>
    <nct_id>NCT04429750</nct_id>
  </id_info>
  <brief_title>Intact Cord Resuscitation in CDH</brief_title>
  <acronym>CHIC</acronym>
  <official_title>Efficacy of Intact Cord Resuscitation Compared to Immediate Cord Clamping on Cardiorespiratory Adaptation at Birth in Infants With Isolated Congenital Diaphragmatic Hernia (CDH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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>
      Isolated CDH is a rare disease (1/3500) and displays a wide range of severity and outcome.&#xD;
      Despite attempts to standardize the management of this disease at birth and during the first&#xD;
      months of life, the mortality varies from 20 to 50% according to different hospitals in&#xD;
      France and abroad.&#xD;
&#xD;
      Several studies already showed the benefice of late cord clamping at birth on biological and&#xD;
      physiological adaptation of newborns to life. Previous works also suggest a possible benefit&#xD;
      of this procedure for babies with CDH.&#xD;
&#xD;
      This multicenter randomized clinical study aims to investigate the efficacy of intact cord&#xD;
      resuscitation compared to immediate cord clamping on cardiorespiratory adaptation at birth in&#xD;
      full term newborn infants with isolated CDH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 8, 2020</start_date>
  <completion_date type="Anticipated">October 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2025</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of infants with APGAR score &lt; 4 at 1 min or &lt; 7 at 5 min.</measure>
    <time_frame>during the first ten minutes after birth</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>APGAR score</measure>
    <time_frame>during the first ten minutes after birth</time_frame>
    <description>APGAR at 1, 5 and 10 minutes after birth will be reassessed retrospectively by a final observer. The reassessment will be carried out using a video of the first 10 minutes of life of the newborn filmed with a camera if the parents agree. This video will only record the appearance of babies' bodies and faces</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of postpartum hemorrhage (PPH) defined by blood loss ≥ 500 ml</measure>
    <time_frame>during the deliverance time</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of severe PPH, defined by measured blood loss ≥ 1000 ml</measure>
    <time_frame>during the deliverance time</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss volume after birth</measure>
    <time_frame>at 15 minutes after birth, at 1hours after birth</time_frame>
    <description>the collector bag will have to be left in place at least 15 minutes to have one measure of blood loss at the same time point in all women</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of infants with the need for chest compressions</measure>
    <time_frame>during the deliverance time</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of infants with the need for epinephrine administration and/or fluid resuscitation</measure>
    <time_frame>during the deliverance time</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>at 1, 5, and 10 min after birth and at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days</time_frame>
    <description>a pulse oximeter sensor will be placed at the right hand as soon as possible (within the first minute after birth), which then will be connected to a pulse oximeter;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma lactate concentration</measure>
    <time_frame>at one hour after birth (H1): at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days</time_frame>
    <description>these quantitative variables can be considered as objective markers of early cardiorespiratory adaptation at birth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of global Blood gases parameters</measure>
    <time_frame>at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days</time_frame>
    <description>pre- and postductal SpO2,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of ventilatory parameters</measure>
    <time_frame>at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days</time_frame>
    <description>peak inspiratory pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of ventilatory parameters</measure>
    <time_frame>at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days</time_frame>
    <description>respiratory rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of fluid resuscitation</measure>
    <time_frame>during the first 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of infants with the need for vasoactive drugs ;</measure>
    <time_frame>during the first 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of infants with the need for pulmonary vasodilator</measure>
    <time_frame>during the first 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin concentration</measure>
    <time_frame>at 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant mortality rate</measure>
    <time_frame>at 90-day after birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant morbidity outcomes assessed within the first 90 days after birth</measure>
    <time_frame>at 90-day after birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of refusal of participating to the protocol.</measure>
    <time_frame>at the end of the study period (90±7 days after birth)</time_frame>
    <description>the reasons for refusal will be recorded : do not want to participate to a research protocol, to not want to be randomized in the immediate cord clamping group, to not want to be randomized in the intact cord resuscitation group;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State Trait Anxiety Inventory (STAI) revised version, form Y</measure>
    <time_frame>within the first 48 hours after birth, and at the end of the study period (90±7 days after birth).</time_frame>
    <description>The STAI is a self-report scale translated in French (1). The scale includes 20 questions, and takes approximately 5 minutes to complete. It is widely used and usually well accepted. Both parents will be requested to answer the questionnaire at two distinct moments. The first will be within the first 48 hours after birth, and the second will be during the medical consultation at the end of the study period (90±7 days after birth).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Impact of Event Scale-Revised (IES-R)</measure>
    <time_frame>during the 7 days prior to completion and at the end of the study period (90±7 days after birth).</time_frame>
    <description>The IES-R is made up of 22 items aimed at assessing three main factors of traumatic symptoms (intrusion, avoidance and numbing, and hyperarousal) linked to a specific stressful event. The questions pertain to symptoms occurring during the 7 days prior to completion. The scale usually takes approximately 5 minutes to complete. Parents will be requested to answer the questionnaire during the medical consultation at the end of the study period (90±7 days after birth).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the Intolerance for Uncertainty Scale (EII).</measure>
    <time_frame>at the end of the study period (90±7 days after birth).</time_frame>
    <description>This self-report scale was originally designed in French and includes 27 questions pertaining to the beliefs and representations held by individuals with regards to uncertainty. The scale is usually completed in approximately 10 minutes. Parents will be requested to answer the questionnaire during the medical consultation at the end of the study period (90±7 days after birth).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Semi-structured interviews</measure>
    <time_frame>at the end of the study period (12 months after birth)</time_frame>
    <description>Semi-structured interviews will be proposed by a psychologist to the parents whatever the issue, to assess their personal experience of the resuscitating period at birth, including both early/delayed cord clamping and close/remote resuscitation maneuvers. The interviews tape recordings will be transcribed and then analyzed using thematic coding. The anonymized data will be independently coded by three researchers and compared for consistency of interpretation. The themes that emerged following the final coding will be used for a qualitative analysis of the parental verbatim; Due to he's or her's initial condition (HCD), if the newborn dies before the end of the study, the parents will not be asked to get through the psychological questionnaires and interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the 'faceless' acute neonatal pain scale (FANS)</measure>
    <time_frame>during intubation</time_frame>
    <description>FANS, which doesn't include items on facial expression, is particularly adapted for evaluating acute pain in newborns during intubation. Pain assessment is based on the analysis of limb movement, vocal expression and autonomic reactions, including heart rate variations and the occurrence of bradycardia or desaturation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral Near-infrared spectroscopy recorded</measure>
    <time_frame>at H1, H2, H6, H12, H24, H48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echographic parameters with the Resistive index and pulsatility index in the anterior cerebral artery</measure>
    <time_frame>at H6, H24, H24 after the chirurgical CDH repair gesture, H48, D7, D28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A parental questionnaire to assess neurological development (ASQ 3 score).</measure>
    <time_frame>at M6 and M12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Rare Diseases</condition>
  <condition>Congenital Diaphragmatic Hernia</condition>
  <arm_group>
    <arm_group_label>Immediate umbilical cord clamping</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group includes newborn infants with isolated CDH who will benefit from the standardized CDH management procedure as described in the French national CDH management guidelines (&quot;Programme National de Soins&quot;).The resuscitation maneuvers are started after the umbilical cord is clamped.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intact cord resuscitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group includes newborn infants with isolated CDH who will benefit from the standardized CDH resuscitation maneuvers as described in the French national CDH management guidelines (&quot;Programme National de Soins&quot;) before the umbilical cord is clamped. The resuscitation maneuvers are started at birth while the umbilical cord still bridges mother and child.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Immediate umbilical cord clamping</intervention_name>
    <description>In the immediate cord clamping group, the umbilical cord will be clamped within the first 20 seconds after birth and the infant will be transferred to the resuscitation room. The newborn infant will be intubated and mechanically ventilated as quickly as possible on the resuscitation table as recommended in the French &quot;Programme National de Soins&quot;.&#xD;
After cardiorespiratory stabilization (i.e. heart rate&gt;120/min, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets between 80 and 95%), the infant will be transferred to the neonatal intensive care unit (NICU). Oxytocin is infused to the mother as recommended in the local protocol (usually just after birth or cord clamping).</description>
    <arm_group_label>Immediate umbilical cord clamping</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intact cord resuscitation</intervention_name>
    <description>The umbilical cord will be kept intact during the initial phase of the resuscitation. The infant will be placed on a specifically designed compact trolley with a warmed platform, suitable for commencing resuscitation between the mother's legs in case of vaginal birth or near the operating table beside the mother in case of cesarean section. This trolley will be fully equipped for resuscitation, including a suction device, gas flowmeter/blender, ventilatory support, and monitoring system. Its height can be adjusted in order to position the infant close to the maternal perineum. The infant will be intubated and mechanically ventilated on this trolley. The cord will be clamped once cardiorespiratory stabilization will be obtained (i.e. heart rate&gt;120/min, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets between 80 and 95%) or in case of spontaneous placental expulsion. The infant will be then transferred to the neonatal intensive care unit (NICU).</description>
    <arm_group_label>Intact cord resuscitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Antenatal diagnosis of CDH&#xD;
&#xD;
          -  No severe additional malformation or chromosomal diseases&#xD;
&#xD;
          -  Full term (&gt;36 weeks gestational age)&#xD;
&#xD;
          -  No inclusion in another antenatal trial&#xD;
&#xD;
          -  Written informed consents from the parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preterm birth less than 37 weeks gestational age&#xD;
&#xD;
          -  Other severe malformation(s) or chromosomal diseases&#xD;
&#xD;
          -  Twin&#xD;
&#xD;
          -  Parents who may have French language understanding difficulties may not participate to&#xD;
             the study unless they receive appropriate assistance regarding the understanding of&#xD;
             the formal consent forms needed to get included in the study. If included in the&#xD;
             study, regarding their French understanding level, the parents may not be proposed the&#xD;
             auto questionnaires and interviews led by the psychologist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>36 Weeks</minimum_age>
    <maximum_age>37 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurent Storme, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurent Storme, MD,PhD</last_name>
    <phone>03 20 44 61 99</phone>
    <phone_ext>+33</phone_ext>
    <email>laurent.storme@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Amiens Picardie</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hop Jeanne de Flandre Chu Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>0320445962</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu de Nantes -</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>March 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Congenital diaphragmatic hernia</keyword>
  <keyword>resuscitation</keyword>
  <keyword>delayed cord clamping</keyword>
  <keyword>newborn</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernias, Diaphragmatic, Congenital</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Rare Diseases</mesh_term>
    <mesh_term>Hernia, Diaphragmatic</mesh_term>
  </condition_browse>
  <!-- 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/NCT04429750
org study id: 2018_94
secondary id: 2019-A01030-57
secondary id: PHRC-18-0234
nct id: NCT04429750
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Isolated CDH is a rare disease (1/3500) and displays a wide range of severity and outcome.
      Despite attempts to standardize the management of this disease at birth and during the first
      months of life, the mortality varies from 20 to 50% according to different hospitals in
      France and abroad.

      Several studies already showed the benefice of late cord clamping at birth on biological and
      physiological adaptation of newborns to life. Previous works also suggest a possible benefit
      of this procedure for babies with CDH.

      This multicenter randomized clinical study aims to investigate the efficacy of intact cord
      resuscitation compared to immediate cord clamping on cardiorespiratory adaptation at birth in
      full term newborn infants with isolated CDH.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of infants with APGAR score < 4 at 1 min or < 7 at 5 min.
time frame: during the first ten minutes after birth
measure: APGAR score
time frame: during the first ten minutes after birth
description: APGAR at 1, 5 and 10 minutes after birth will be reassessed retrospectively by a final observer. The reassessment will be carried out using a video of the first 10 minutes of life of the newborn filmed with a camera if the parents agree. This video will only record the appearance of babies' bodies and faces
measure: Frequency of postpartum hemorrhage (PPH) defined by blood loss ≥ 500 ml
time frame: during the deliverance time
measure: Frequency of severe PPH, defined by measured blood loss ≥ 1000 ml
time frame: during the deliverance time
measure: Blood loss volume after birth
time frame: at 15 minutes after birth, at 1hours after birth
description: the collector bag will have to be left in place at least 15 minutes to have one measure of blood loss at the same time point in all women
measure: Frequency of infants with the need for chest compressions
time frame: during the deliverance time
measure: Frequency of infants with the need for epinephrine administration and/or fluid resuscitation
time frame: during the deliverance time
measure: Heart rate
time frame: at 1, 5, and 10 min after birth and at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
description: a pulse oximeter sensor will be placed at the right hand as soon as possible (within the first minute after birth), which then will be connected to a pulse oximeter;
measure: plasma lactate concentration
time frame: at one hour after birth (H1): at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
description: these quantitative variables can be considered as objective markers of early cardiorespiratory adaptation at birth.
measure: changes of global Blood gases parameters
time frame: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
description: pre- and postductal SpO2,
measure: changes of ventilatory parameters
time frame: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
description: peak inspiratory pressure
measure: changes of ventilatory parameters
time frame: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
description: respiratory rate
measure: Volume of fluid resuscitation
time frame: during the first 24 hours
measure: Frequency of infants with the need for vasoactive drugs ;
time frame: during the first 24 hours
measure: Frequency of infants with the need for pulmonary vasodilator
time frame: during the first 24 hours
measure: Hemoglobin concentration
time frame: at 24 hours
measure: Infant mortality rate
time frame: at 90-day after birth
measure: Infant morbidity outcomes assessed within the first 90 days after birth
time frame: at 90-day after birth
measure: Number of refusal of participating to the protocol.
time frame: at the end of the study period (90±7 days after birth)
description: the reasons for refusal will be recorded : do not want to participate to a research protocol, to not want to be randomized in the immediate cord clamping group, to not want to be randomized in the intact cord resuscitation group;
measure: State Trait Anxiety Inventory (STAI) revised version, form Y
time frame: within the first 48 hours after birth, and at the end of the study period (90±7 days after birth).
description: The STAI is a self-report scale translated in French (1). The scale includes 20 questions, and takes approximately 5 minutes to complete. It is widely used and usually well accepted. Both parents will be requested to answer the questionnaire at two distinct moments. The first will be within the first 48 hours after birth, and the second will be during the medical consultation at the end of the study period (90±7 days after birth).
measure: the Impact of Event Scale-Revised (IES-R)
time frame: during the 7 days prior to completion and at the end of the study period (90±7 days after birth).
description: The IES-R is made up of 22 items aimed at assessing three main factors of traumatic symptoms (intrusion, avoidance and numbing, and hyperarousal) linked to a specific stressful event. The questions pertain to symptoms occurring during the 7 days prior to completion. The scale usually takes approximately 5 minutes to complete. Parents will be requested to answer the questionnaire during the medical consultation at the end of the study period (90±7 days after birth).
measure: the Intolerance for Uncertainty Scale (EII).
time frame: at the end of the study period (90±7 days after birth).
description: This self-report scale was originally designed in French and includes 27 questions pertaining to the beliefs and representations held by individuals with regards to uncertainty. The scale is usually completed in approximately 10 minutes. Parents will be requested to answer the questionnaire during the medical consultation at the end of the study period (90±7 days after birth).
measure: Semi-structured interviews
time frame: at the end of the study period (12 months after birth)
description: Semi-structured interviews will be proposed by a psychologist to the parents whatever the issue, to assess their personal experience of the resuscitating period at birth, including both early/delayed cord clamping and close/remote resuscitation maneuvers. The interviews tape recordings will be transcribed and then analyzed using thematic coding. The anonymized data will be independently coded by three researchers and compared for consistency of interpretation. The themes that emerged following the final coding will be used for a qualitative analysis of the parental verbatim; Due to he's or her's initial condition (HCD), if the newborn dies before the end of the study, the parents will not be asked to get through the psychological questionnaires and interviews
measure: the 'faceless' acute neonatal pain scale (FANS)
time frame: during intubation
description: FANS, which doesn't include items on facial expression, is particularly adapted for evaluating acute pain in newborns during intubation. Pain assessment is based on the analysis of limb movement, vocal expression and autonomic reactions, including heart rate variations and the occurrence of bradycardia or desaturation.
measure: Cerebral Near-infrared spectroscopy recorded
time frame: at H1, H2, H6, H12, H24, H48
measure: Echographic parameters with the Resistive index and pulsatility index in the anterior cerebral artery
time frame: at H6, H24, H24 after the chirurgical CDH repair gesture, H48, D7, D28
measure: A parental questionnaire to assess neurological development (ASQ 3 score).
time frame: at M6 and M12
arm group label: Immediate umbilical cord clamping
arm group type: Active Comparator
description: This group includes newborn infants with isolated CDH who will benefit from the standardized CDH management procedure as described in the French national CDH management guidelines ("Programme National de Soins").The resuscitation maneuvers are started after the umbilical cord is clamped.
arm group label: Intact cord resuscitation
arm group type: Experimental
description: This group includes newborn infants with isolated CDH who will benefit from the standardized CDH resuscitation maneuvers as described in the French national CDH management guidelines ("Programme National de Soins") before the umbilical cord is clamped. The resuscitation maneuvers are started at birth while the umbilical cord still bridges mother and child.
intervention type: Procedure
intervention name: Immediate umbilical cord clamping
description: In the immediate cord clamping group, the umbilical cord will be clamped within the first 20 seconds after birth and the infant will be transferred to the resuscitation room. The newborn infant will be intubated and mechanically ventilated as quickly as possible on the resuscitation table as recommended in the French "Programme National de Soins".
After cardiorespiratory stabilization (i.e. heart rate>120/min, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets between 80 and 95%), the infant will be transferred to the neonatal intensive care unit (NICU). Oxytocin is infused to the mother as recommended in the local protocol (usually just after birth or cord clamping).
arm group label: Immediate umbilical cord clamping
intervention type: Procedure
intervention name: intact cord resuscitation
description: The umbilical cord will be kept intact during the initial phase of the resuscitation. The infant will be placed on a specifically designed compact trolley with a warmed platform, suitable for commencing resuscitation between the mother's legs in case of vaginal birth or near the operating table beside the mother in case of cesarean section. This trolley will be fully equipped for resuscitation, including a suction device, gas flowmeter/blender, ventilatory support, and monitoring system. Its height can be adjusted in order to position the infant close to the maternal perineum. The infant will be intubated and mechanically ventilated on this trolley. The cord will be clamped once cardiorespiratory stabilization will be obtained (i.e. heart rate>120/min, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets between 80 and 95%) or in case of spontaneous placental expulsion. The infant will be then transferred to the neonatal intensive care unit (NICU).
arm group label: Intact cord resuscitation
criteria: 
gender: All
minimum age: 36 Weeks
maximum age: 37 Weeks
healthy volunteers: No
last name: Laurent Storme, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Laurent Storme, MD,PhD
phone: 03 20 44 61 99
phone ext: +33
email: laurent.storme@chru-lille.fr
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Hernias, Diaphragmatic, Congenital
mesh term: Hernia
mesh term: Rare Diseases
mesh term: Hernia, Diaphragmatic