<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/NCT03770104</url>
  </required_header>
  <id_info>
    <org_study_id>Neo TEDI</org_study_id>
    <nct_id>NCT03770104</nct_id>
  </id_info>
  <brief_title>Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room</brief_title>
  <acronym>Intubated-DR</acronym>
  <official_title>Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room According to Two Different Methods Based on Estimated Birth Weight. Randomized Clinical Trial (NeoTEDI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tania Carbayo Jiménez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario 12 de Octubre</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 investigators wished to determine whether estimating endotracheal tube (ETT) insertion&#xD;
      depth using the formula given by Spanish guidelines recommendations (5,5 plus weight) rather&#xD;
      than the depth using the formula given by international guidelines recommendations (6 plus&#xD;
      weight) resulted in more correctly positioned endotracheal tube tips in newborns intubated in&#xD;
      the delivery room.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A number of different methods have been used to guide clinicians in estimating the correct&#xD;
      depth of insertion of endotracheal tube (ETT) at the time of oral intubation. Minor&#xD;
      differences in tube length may lead to intubation of the right main bronchus or extubation.&#xD;
      However, none of them has shown to be better than others when compared in the context of&#xD;
      randomized clinical trials.&#xD;
&#xD;
      Commonly, clinicians use a formula based on the newborn's weight (Tochen formula: ETT&#xD;
      insertion depth (cm)=6 + wt (kg)). While this method is widely used and recommended by&#xD;
      international guidelines, it has been found to frequently result in incorrectly positioned&#xD;
      tubes, especially in infants &lt;1000 g in weight in whom it may lead to overestimation of ETT&#xD;
      insertion depth.&#xD;
&#xD;
      On the other hand, Spanish Society of Neonatology recommended in their last published&#xD;
      guidelines (2017) to use an alternative version formula (ETT insertion depth (cm)=5.5 + wt&#xD;
      (kg)), which is commonly used among Spanish neonatal units.&#xD;
&#xD;
      Finally, no studies have been performed in newborns who require oral intubation in the&#xD;
      delivery room, since these intubations are usually excluded because infants are not routinely&#xD;
      weighed prior to resuscitation and weight can not be rapidly obtained. Given that Obstetric&#xD;
      Unit in our hospital is a high standard one with a highly reliable estimated fetal weight in&#xD;
      prenatal ultrasound, the investigators will use estimated fetal weight referred on&#xD;
      ultrasounds or 50th percentile for gestational age for calculations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Clinicians and neonatal nurses will not masked to group assignment. However, Neonatal Intensive Care Unit nurses who take care of the patient will be mask, as well as both pediatric radiologist who will determine the main outcome of the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of correct endotracheal tube (ETT) position</measure>
    <time_frame>1 hour</time_frame>
    <description>Correct ETT position, that is, tip between the upper border of the first thoracic vertebra (T1) and the lower border of the second thoracic vertebra (T2) on a chest X-ray as determined by one pediatric radiologist masked to group assignment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of intubation attempts in the delivery room</measure>
    <time_frame>2 days</time_frame>
    <description>Number of intubation attempts in the delivery room by healthcare professionals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of accidental extubations prior to chest X-ray</measure>
    <time_frame>2 days</time_frame>
    <description>Number of accidental extubations prior to chest X-ray confirmation of ETT position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of ETT repositioning prior and after chest X-ray</measure>
    <time_frame>2 days</time_frame>
    <description>ETT repositioning prior and after chest X-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of incorrect ETT position</measure>
    <time_frame>2 days</time_frame>
    <description>Incorrect ETT position (too low or too high)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of complications secondary to incorrect ETT position</measure>
    <time_frame>7 days</time_frame>
    <description>Complications secondary to incorrect ETT position (air leak, unplanned extubation, atelectasis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Professional healthcare sensation about correct or incorrect ETT position</measure>
    <time_frame>1 day</time_frame>
    <description>Professional healthcare sensation about correct or incorrect ETT position, before confirmation with Chest X-ray confirmation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of ventilation</measure>
    <time_frame>3 months</time_frame>
    <description>Duration of ventilation in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen therapy at 28 days</measure>
    <time_frame>1 month</time_frame>
    <description>Oxygen therapy at 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen therapy at 36 weeks postmenstrual age</measure>
    <time_frame>3 months</time_frame>
    <description>Oxygen therapy at 36 weeks postmenstrual age</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Presence of intraventricular hemorrhage or central nervous system lesion</measure>
    <time_frame>3 months</time_frame>
    <description>Presence of intraventricular hemorrhage or central nervous system lesion</description>
  </other_outcome>
  <other_outcome>
    <measure>Death before discharge from the hospital</measure>
    <time_frame>4 months</time_frame>
    <description>Death before discharge from the hospital</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Intubation Complication</condition>
  <condition>Newborn Morbidity</condition>
  <condition>Cardiopulmonary Resuscitation</condition>
  <arm_group>
    <arm_group_label>Intervention Group (5.5 plus weight)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ETT insertion depth using Spanish recommendations Patients included in the intervention group arm who are included in the study will be intubated using Spanish recommendations (5.5 plus weight) to estimate insertion endotracheal tube depth. In addition, every arm will be divided into 2 subgroups depending on gestational age (under 32 weeks or equal/over 32 weeks' gestation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (6 plus weight)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ETT insertion depth using international recommendations Patients included in the intervention group arm who are included in the study will be intubated using international recommendations (6 plus weight) to estimate insertion endotracheal tube depth. In addition, every arm will be divided into 2 subgroups depending on gestational age (under 32 weeks or equal/over 32 weeks' gestation).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ETT insertion depth using Spanish recommendations</intervention_name>
    <description>Infants included in this assignment group will be intubated using the formula 5.5 plus weight, when requiring oral intubation in the delivery room.</description>
    <arm_group_label>Intervention Group (5.5 plus weight)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ETT insertion depth using international recommendations</intervention_name>
    <description>Infants included in this assignment group will be intubated using the formula 6 plus weight, when requiring oral intubation in the delivery room.</description>
    <arm_group_label>Control Group (6 plus weight)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All newborns requiring endotracheal oral intubation in the delivery room after birth.&#xD;
&#xD;
          -  Parents accept deferred informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior to randomization&#xD;
&#xD;
          -  Uncontrolled gestation where both estimated fetal weight and gestational age are&#xD;
             unknown.&#xD;
&#xD;
          -  Upper airway anomaly or a lung anomaly that would distort the upper airway anatomy.&#xD;
&#xD;
          -  Infants who require nasotracheal intubation&#xD;
&#xD;
          -  Infants who are intubated in the Neonatal Intensive Care Unit&#xD;
&#xD;
          -  Post-randomization&#xD;
&#xD;
          -  Newborns who are randomized but finally do not require intubation&#xD;
&#xD;
          -  Intubated newborns who are electively extubated in the delivery room&#xD;
&#xD;
          -  Parents / legal guardian refuse to give consent to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Day</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tania Carbayo Jimenez, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Universitario 12 de Octubre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tania Carbayo Jimenez, M.D.</last_name>
    <phone>0034 91 390 8272</phone>
    <email>tania.carbayo@salud.madrid.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carmen Rosa Pallás Alonso, M.D.; Ph.D.</last_name>
    <phone>0034 913908273</phone>
    <email>carmenrosa.pallas@salud.madrid.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre. Neonatology Department.</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>María Soriano-Ramos, M.D.</last_name>
      <phone>0034 91390 8272</phone>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Flinn AM, Travers CP, Laffan EE, O'Donnell CP. Estimating the endotracheal tube insertion depth in newborns using weight or gestation: a randomised trial. Neonatology. 2015;107(3):167-72. doi: 10.1159/000369375.</citation>
    <PMID>25592171</PMID>
  </reference>
  <reference>
    <citation>Gill I, Stafford A, Murphy MC, Geoghegan AR, Crealey M, Laffan E, O'Donnell CPF. Randomised trial of estimating oral endotracheal tube insertion depth in newborns using weight or vocal cord guide. Arch Dis Child Fetal Neonatal Ed. 2018 Jul;103(4):F312-F316. doi: 10.1136/archdischild-2017-312798. Epub 2017 Sep 7.</citation>
    <PMID>28883098</PMID>
  </reference>
  <reference>
    <citation>Tochen ML. Orotracheal intubation in the newborn infant: a method for determining depth of tube insertion. J Pediatr. 1979 Dec;95(6):1050-1. doi: 10.1016/s0022-3476(79)80309-1. No abstract available.</citation>
    <PMID>501484</PMID>
  </reference>
  <reference>
    <citation>Amarilyo G, Mimouni FB, Oren A, Tsyrkin S, Mandel D. Orotracheal tube insertion in extremely low birth weight infants. J Pediatr. 2009 May;154(5):764-5. doi: 10.1016/j.jpeds.2008.11.057.</citation>
    <PMID>19364561</PMID>
  </reference>
  <reference>
    <citation>Peterson J, Johnson N, Deakins K, Wilson-Costello D, Jelovsek JE, Chatburn R. Accuracy of the 7-8-9 Rule for endotracheal tube placement in the neonate. J Perinatol. 2006 Jun;26(6):333-6. doi: 10.1038/sj.jp.7211503.</citation>
    <PMID>16642028</PMID>
  </reference>
  <reference>
    <citation>Kempley ST, Moreiras JW, Petrone FL. Endotracheal tube length for neonatal intubation. Resuscitation. 2008 Jun;77(3):369-73. doi: 10.1016/j.resuscitation.2008.02.002. Epub 2008 Mar 26.</citation>
    <PMID>18372092</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>June 12, 2021</last_update_submitted>
  <last_update_submitted_qc>June 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario 12 de Octubre</investigator_affiliation>
    <investigator_full_name>Tania Carbayo Jiménez</investigator_full_name>
    <investigator_title>Tania Carbayo Jimenez, MD</investigator_title>
  </responsible_party>
  <keyword>Intubation</keyword>
  <keyword>Newborn</keyword>
  <keyword>Delivery room</keyword>
  <keyword>Complications</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/NCT03770104
org study id: Neo TEDI
nct id: NCT03770104
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators wished to determine whether estimating endotracheal tube (ETT) insertion
      depth using the formula given by Spanish guidelines recommendations (5,5 plus weight) rather
      than the depth using the formula given by international guidelines recommendations (6 plus
      weight) resulted in more correctly positioned endotracheal tube tips in newborns intubated in
      the delivery room.
A number of different methods have been used to guide clinicians in estimating the correct
      depth of insertion of endotracheal tube (ETT) at the time of oral intubation. Minor
      differences in tube length may lead to intubation of the right main bronchus or extubation.
      However, none of them has shown to be better than others when compared in the context of
      randomized clinical trials.

      Commonly, clinicians use a formula based on the newborn's weight (Tochen formula: ETT
      insertion depth (cm)=6 + wt (kg)). While this method is widely used and recommended by
      international guidelines, it has been found to frequently result in incorrectly positioned
      tubes, especially in infants <1000 g in weight in whom it may lead to overestimation of ETT
      insertion depth.

      On the other hand, Spanish Society of Neonatology recommended in their last published
      guidelines (2017) to use an alternative version formula (ETT insertion depth (cm)=5.5 + wt
      (kg)), which is commonly used among Spanish neonatal units.

      Finally, no studies have been performed in newborns who require oral intubation in the
      delivery room, since these intubations are usually excluded because infants are not routinely
      weighed prior to resuscitation and weight can not be rapidly obtained. Given that Obstetric
      Unit in our hospital is a high standard one with a highly reliable estimated fetal weight in
      prenatal ultrasound, the investigators will use estimated fetal weight referred on
      ultrasounds or 50th percentile for gestational age for calculations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: Clinicians and neonatal nurses will not masked to group assignment. However, Neonatal Intensive Care Unit nurses who take care of the patient will be mask, as well as both pediatric radiologist who will determine the main outcome of the study.
measure: Frequency of correct endotracheal tube (ETT) position
time frame: 1 hour
description: Correct ETT position, that is, tip between the upper border of the first thoracic vertebra (T1) and the lower border of the second thoracic vertebra (T2) on a chest X-ray as determined by one pediatric radiologist masked to group assignment.
measure: Number of intubation attempts in the delivery room
time frame: 2 days
description: Number of intubation attempts in the delivery room by healthcare professionals
measure: Number of accidental extubations prior to chest X-ray
time frame: 2 days
description: Number of accidental extubations prior to chest X-ray confirmation of ETT position
measure: Frequency of ETT repositioning prior and after chest X-ray
time frame: 2 days
description: ETT repositioning prior and after chest X-ray
measure: Frequency of incorrect ETT position
time frame: 2 days
description: Incorrect ETT position (too low or too high)
measure: Frequency of complications secondary to incorrect ETT position
time frame: 7 days
description: Complications secondary to incorrect ETT position (air leak, unplanned extubation, atelectasis)
measure: Professional healthcare sensation about correct or incorrect ETT position
time frame: 1 day
description: Professional healthcare sensation about correct or incorrect ETT position, before confirmation with Chest X-ray confirmation
measure: Duration of ventilation
time frame: 3 months
description: Duration of ventilation in days
measure: Oxygen therapy at 28 days
time frame: 1 month
description: Oxygen therapy at 28 days
measure: Oxygen therapy at 36 weeks postmenstrual age
time frame: 3 months
description: Oxygen therapy at 36 weeks postmenstrual age
measure: Presence of intraventricular hemorrhage or central nervous system lesion
time frame: 3 months
description: Presence of intraventricular hemorrhage or central nervous system lesion
measure: Death before discharge from the hospital
time frame: 4 months
description: Death before discharge from the hospital
arm group label: Intervention Group (5.5 plus weight)
arm group type: Experimental
description: ETT insertion depth using Spanish recommendations Patients included in the intervention group arm who are included in the study will be intubated using Spanish recommendations (5.5 plus weight) to estimate insertion endotracheal tube depth. In addition, every arm will be divided into 2 subgroups depending on gestational age (under 32 weeks or equal/over 32 weeks' gestation).
arm group label: Control Group (6 plus weight)
arm group type: Experimental
description: ETT insertion depth using international recommendations Patients included in the intervention group arm who are included in the study will be intubated using international recommendations (6 plus weight) to estimate insertion endotracheal tube depth. In addition, every arm will be divided into 2 subgroups depending on gestational age (under 32 weeks or equal/over 32 weeks' gestation).
intervention type: Procedure
intervention name: ETT insertion depth using Spanish recommendations
description: Infants included in this assignment group will be intubated using the formula 5.5 plus weight, when requiring oral intubation in the delivery room.
arm group label: Intervention Group (5.5 plus weight)
intervention type: Procedure
intervention name: ETT insertion depth using international recommendations
description: Infants included in this assignment group will be intubated using the formula 6 plus weight, when requiring oral intubation in the delivery room.
arm group label: Control Group (6 plus weight)
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Day
healthy volunteers: No
last name: Tania Carbayo Jimenez, M.D.
role: Study Chair
affiliation: Hospital Universitario 12 de Octubre
last name: Tania Carbayo Jimenez, M.D.
phone: 0034 91 390 8272
email: tania.carbayo@salud.madrid.org
last name: Carmen Rosa Pallás Alonso, M.D.; Ph.D.
phone: 0034 913908273
email: carmenrosa.pallas@salud.madrid.org
facility: 
status: Recruiting
contact: 
country: Spain
citation: Flinn AM, Travers CP, Laffan EE, O'Donnell CP. Estimating the endotracheal tube insertion depth in newborns using weight or gestation: a randomised trial. Neonatology. 2015;107(3):167-72. doi: 10.1159/000369375.
PMID: 25592171
citation: Gill I, Stafford A, Murphy MC, Geoghegan AR, Crealey M, Laffan E, O'Donnell CPF. Randomised trial of estimating oral endotracheal tube insertion depth in newborns using weight or vocal cord guide. Arch Dis Child Fetal Neonatal Ed. 2018 Jul;103(4):F312-F316. doi: 10.1136/archdischild-2017-312798. Epub 2017 Sep 7.
PMID: 28883098
citation: Tochen ML. Orotracheal intubation in the newborn infant: a method for determining depth of tube insertion. J Pediatr. 1979 Dec;95(6):1050-1. doi: 10.1016/s0022-3476(79)80309-1. No abstract available.
PMID: 501484
citation: Amarilyo G, Mimouni FB, Oren A, Tsyrkin S, Mandel D. Orotracheal tube insertion in extremely low birth weight infants. J Pediatr. 2009 May;154(5):764-5. doi: 10.1016/j.jpeds.2008.11.057.
PMID: 19364561
citation: Peterson J, Johnson N, Deakins K, Wilson-Costello D, Jelovsek JE, Chatburn R. Accuracy of the 7-8-9 Rule for endotracheal tube placement in the neonate. J Perinatol. 2006 Jun;26(6):333-6. doi: 10.1038/sj.jp.7211503.
PMID: 16642028
citation: Kempley ST, Moreiras JW, Petrone FL. Endotracheal tube length for neonatal intubation. Resuscitation. 2008 Jun;77(3):369-73. doi: 10.1016/j.resuscitation.2008.02.002. Epub 2008 Mar 26.
PMID: 18372092
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Universitario 12 de Octubre
investigator full name: Tania Carbayo Jiménez
investigator title: Tania Carbayo Jimenez, MD
sharing ipd: No