<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/NCT03273764</url>
  </required_header>
  <id_info>
    <org_study_id>LadyHardingeMedicalCollege</org_study_id>
    <nct_id>NCT03273764</nct_id>
  </id_info>
  <brief_title>Clinical RD (Respiratory Distress) Score for Objective Decision Making for Surfactant Therapy</brief_title>
  <official_title>Development And Validation Of A Clinical RD Score For Decision Making For Administration Of Surfactant In Preterm Babies With RDS (Respiratory Distress Syndrome) - A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lady Hardinge Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lady Hardinge Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To develop a comprehensive 'Clinical RD score' for decision making for administration of&#xD;
      Surfactant in respiratory distress syndrome in preterm infants with gestation of 26 0/7 - 34&#xD;
      6/7 weeks and to assess the validity of this 'clinical RD score' on a different subgroup of&#xD;
      patients with similar gestational age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Respiratory distress syndrome, also known as hyaline membrane disease, occurs almost&#xD;
      exclusively in premature infants. The incidence and severity of respiratory distress syndrome&#xD;
      are inversely related to the gestational age of the newborn infant. The incidence of RDS is&#xD;
      around 60 - 80% among infants &lt; 28 weeks, 30-40% between 28-34 weeks, less than 5% at 34&#xD;
      weeks and is rarely seen among those &gt; 37 weeks.&#xD;
&#xD;
      The availability of continuous positive airway pressure (CPAP) and natural surfactant have&#xD;
      revolutionised the management of RDS. In 1967, Gregory et al. reported the value of&#xD;
      application of continuous positive airway pressure in the management of RDS. Successful&#xD;
      surfactant replacement therapy in RDS was reported by Fujiwara et al. Besides the use of&#xD;
      Continuous positive airway pressure and surfactant replacement, the other advances include:&#xD;
      Use of antenatal steroids to enhance pulmonary maturity, appropriate resuscitation and&#xD;
      immediate use of CPAP for alveolar recruitment, Use of gentler modes of ventilation like&#xD;
      patient triggered ventilation, Supportive therapies, such as the diagnosis and management of&#xD;
      patent ductus arteriosus (PDA), fluid and electrolyte management, trophic feeding and&#xD;
      nutrition.&#xD;
&#xD;
      The use of CPAP applied to the alveoli has been shown to stabilise and improve respiratory&#xD;
      distress in preterm babies. It preserves the action of endogenous surfactant and may also&#xD;
      obviate the need for surfactant in a substantial number of cases. CPAP is cost effective and&#xD;
      more patient friendly than mechanical ventilation. Availability of CPAP even at the district&#xD;
      level Special Newborn Care Unit (SNCU) in various states across the country make it an ideal&#xD;
      candidate for respiratory support in the high risk population.&#xD;
&#xD;
      In addition to optimal respiratory support in the form of continuous positive airway pressure&#xD;
      (CPAP) or mechanical ventilation and good supportive care, surfactant replacement therapy&#xD;
      (SRT) forms the mainstay in the management of RDS. Since the report by Fujiwara in 1980 of&#xD;
      the first successful use of SRT, numerous randomized controlled trials (RCTs) and their&#xD;
      meta-analyses have established its efficacy in reducing mortality and air leak syndromes in&#xD;
      RDS. Almost all the trials evaluating the role of SRT were conducted in high-income&#xD;
      countries. Not surprisingly, SRT is the standard of care in neonates with RDS in these&#xD;
      countries.&#xD;
&#xD;
      The population in low and middle income countries (LMIC) like India may differ significantly&#xD;
      from the western world. But whether the evidence from these high income countries can be&#xD;
      extrapolated to LMICs, still remains questionable. High cost of surfactant therapy, issue&#xD;
      regarding regular supply of the drug, lack of skilled personnel, poor antenatal steroid&#xD;
      coverage of mothers with preterm labour, higher incidence of perinatal hypoxia/ischemia and&#xD;
      infections all complicate the clinical course of RDS. The paucity of evidence for efficacy&#xD;
      and/ or safety of SRT in these settings further add to the complexity.&#xD;
&#xD;
      Continuous positive airway pressure (CPAP) remains as the first line of respiratory support&#xD;
      in spontaneously breathing infants with RDS and surfactant is administered if required. The&#xD;
      beneficial effects of surfactant are more pronounced when the therapy is started earlier. In&#xD;
      most of the units across the country, the decision to administer surfactant to such babies&#xD;
      managed on CPAP is clinician oriented and hence remains highly subjective. There are no&#xD;
      objective criteria to decide for administration of surfactant to infants who are initially&#xD;
      managed with CPAP. The current study was planned keeping in mind the beneficial effects of&#xD;
      early CPAP and early surfactant, with the aim of developing an objective scoring system,&#xD;
      which would guide the clinician in decision making for administration of surfactant to&#xD;
      infants with RDS who are already being managed with CPAP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 23, 2016</completion_date>
  <primary_completion_date type="Actual">September 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Developement of a clinical RD score for decision making for administration of surfactant in preterm babies with RDS</measure>
    <time_frame>January 2015 to September 2016</time_frame>
    <description>The study will be conducted in 2 parts.Written informed consent will be obtained from one of the parents of the eligible neonates. The demographic and clinical data related to all putative risk factors will be recorded at the time of enrollment from all eligible neonates in the age group of 26-34 weeks with clinical features suggestive of RDS/HMD (Hyaline Membrane Disease). The putative risk factors which could potentially increase the chances of surfactant administration to the infant will be documented and will be analysed through logistic regression analysis and clinical RD score will be developed. The score developed in the first part of the study will be applied on a different population of preterm infants with RDS with similar gestational age.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">209</enrollment>
  <condition>Respiratory Distress Syndrome in Premature Infant</condition>
  <condition>Surfactant</condition>
  <condition>CPAP</condition>
  <arm_group>
    <arm_group_label>Preterm neonates with RDS</arm_group_label>
    <description>Singleton Preterm neonates with gestational age between 26 completed weeks to 34 completed weeks with clinical diagnosis of RDS without any major congenital anomalies.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Preterm neonates between 26 weeks to 34 weeks of gestation with a clinical diagnosis of&#xD;
        RDS.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonates between 26 0/7-34 6/7 weeks of gestation who were delivered in the hospital&#xD;
             with clinical diagnosis of respiratory distress syndrome were eligible for inclusion&#xD;
             for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major congenital malformation&#xD;
&#xD;
          -  Antenatally diagnosed congenital heart disease in fetus.&#xD;
&#xD;
          -  Hydrops fetalis&#xD;
&#xD;
          -  Massive Pulmonary hemorrhage prior to enrolment&#xD;
&#xD;
          -  Shock requiring vasopressor support prior to enrolment&#xD;
&#xD;
          -  Non availability of CPAP/ventilator in the unit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>26 Weeks</minimum_age>
    <maximum_age>34 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sushma Nangia, MBBS, MD, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kalawati Saran Chindren Hospital and Lady Hardinge Medical College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Debasish Nanda, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kalawati Saran Chindren Hospital and Lady Hardinge Medical College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lady Hardinge Medical college</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 10, 2017</last_update_submitted>
  <last_update_submitted_qc>September 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lady Hardinge Medical College</investigator_affiliation>
    <investigator_full_name>Sushma Nangia, M.D.</investigator_full_name>
    <investigator_title>Director professor and head of department</investigator_title>
  </responsible_party>
  <keyword>Preterm, RDS, Surfactant, CPAP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Syndrome</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/NCT03273764
org study id: LadyHardingeMedicalCollege
nct id: NCT03273764
lead sponsor: 
has dmc: Yes
To develop a comprehensive 'Clinical RD score' for decision making for administration of
      Surfactant in respiratory distress syndrome in preterm infants with gestation of 26 0/7 - 34
      6/7 weeks and to assess the validity of this 'clinical RD score' on a different subgroup of
      patients with similar gestational age.
Respiratory distress syndrome, also known as hyaline membrane disease, occurs almost
      exclusively in premature infants. The incidence and severity of respiratory distress syndrome
      are inversely related to the gestational age of the newborn infant. The incidence of RDS is
      around 60 - 80% among infants < 28 weeks, 30-40% between 28-34 weeks, less than 5% at 34
      weeks and is rarely seen among those > 37 weeks.

      The availability of continuous positive airway pressure (CPAP) and natural surfactant have
      revolutionised the management of RDS. In 1967, Gregory et al. reported the value of
      application of continuous positive airway pressure in the management of RDS. Successful
      surfactant replacement therapy in RDS was reported by Fujiwara et al. Besides the use of
      Continuous positive airway pressure and surfactant replacement, the other advances include:
      Use of antenatal steroids to enhance pulmonary maturity, appropriate resuscitation and
      immediate use of CPAP for alveolar recruitment, Use of gentler modes of ventilation like
      patient triggered ventilation, Supportive therapies, such as the diagnosis and management of
      patent ductus arteriosus (PDA), fluid and electrolyte management, trophic feeding and
      nutrition.

      The use of CPAP applied to the alveoli has been shown to stabilise and improve respiratory
      distress in preterm babies. It preserves the action of endogenous surfactant and may also
      obviate the need for surfactant in a substantial number of cases. CPAP is cost effective and
      more patient friendly than mechanical ventilation. Availability of CPAP even at the district
      level Special Newborn Care Unit (SNCU) in various states across the country make it an ideal
      candidate for respiratory support in the high risk population.

      In addition to optimal respiratory support in the form of continuous positive airway pressure
      (CPAP) or mechanical ventilation and good supportive care, surfactant replacement therapy
      (SRT) forms the mainstay in the management of RDS. Since the report by Fujiwara in 1980 of
      the first successful use of SRT, numerous randomized controlled trials (RCTs) and their
      meta-analyses have established its efficacy in reducing mortality and air leak syndromes in
      RDS. Almost all the trials evaluating the role of SRT were conducted in high-income
      countries. Not surprisingly, SRT is the standard of care in neonates with RDS in these
      countries.

      The population in low and middle income countries (LMIC) like India may differ significantly
      from the western world. But whether the evidence from these high income countries can be
      extrapolated to LMICs, still remains questionable. High cost of surfactant therapy, issue
      regarding regular supply of the drug, lack of skilled personnel, poor antenatal steroid
      coverage of mothers with preterm labour, higher incidence of perinatal hypoxia/ischemia and
      infections all complicate the clinical course of RDS. The paucity of evidence for efficacy
      and/ or safety of SRT in these settings further add to the complexity.

      Continuous positive airway pressure (CPAP) remains as the first line of respiratory support
      in spontaneously breathing infants with RDS and surfactant is administered if required. The
      beneficial effects of surfactant are more pronounced when the therapy is started earlier. In
      most of the units across the country, the decision to administer surfactant to such babies
      managed on CPAP is clinician oriented and hence remains highly subjective. There are no
      objective criteria to decide for administration of surfactant to infants who are initially
      managed with CPAP. The current study was planned keeping in mind the beneficial effects of
      early CPAP and early surfactant, with the aim of developing an objective scoring system,
      which would guide the clinician in decision making for administration of surfactant to
      infants with RDS who are already being managed with CPAP.
observational model: Cohort
time perspective: Prospective
measure: Developement of a clinical RD score for decision making for administration of surfactant in preterm babies with RDS
time frame: January 2015 to September 2016
description: The study will be conducted in 2 parts.Written informed consent will be obtained from one of the parents of the eligible neonates. The demographic and clinical data related to all putative risk factors will be recorded at the time of enrollment from all eligible neonates in the age group of 26-34 weeks with clinical features suggestive of RDS/HMD (Hyaline Membrane Disease). The putative risk factors which could potentially increase the chances of surfactant administration to the infant will be documented and will be analysed through logistic regression analysis and clinical RD score will be developed. The score developed in the first part of the study will be applied on a different population of preterm infants with RDS with similar gestational age.
arm group label: Preterm neonates with RDS
description: Singleton Preterm neonates with gestational age between 26 completed weeks to 34 completed weeks with clinical diagnosis of RDS without any major congenital anomalies.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 26 Weeks
maximum age: 34 Weeks
healthy volunteers: No
last name: Sushma Nangia, MBBS, MD, DM
role: Principal Investigator
affiliation: Kalawati Saran Chindren Hospital and Lady Hardinge Medical College
last name: Debasish Nanda, MBBS, MD
role: Principal Investigator
affiliation: Kalawati Saran Chindren Hospital and Lady Hardinge Medical College
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Lady Hardinge Medical College
investigator full name: Sushma Nangia, M.D.
investigator title: Director professor and head of department
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Syndrome