<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/NCT02970994</url>
  </required_header>
  <id_info>
    <org_study_id>LadyHardinge MC</org_study_id>
    <nct_id>NCT02970994</nct_id>
  </id_info>
  <brief_title>Linear Growth and Neurobehavioural Outcome in PT Neonates (&lt;34 Wks) at 37 and 40 Wks of CGA</brief_title>
  <official_title>Linear Growth and Neurobehavioural Outcome in Preterm Neonates (&lt;34 Weeks) at 37 Weeks and 40 Weeks of Corrected Gestational Age : 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>
      This study will evaluate the association of linear growth on neurobehavioural outcome in&#xD;
      preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Growth of the preterm infant has historically been defined as weight gain over time. As&#xD;
      weight gain and nutrition have been more extensively studied and their relationships with&#xD;
      neurodevelopmental outcomes have been established, other growth parameters and their&#xD;
      relationships to outcome need to be assessed.&#xD;
&#xD;
      Large multicenteric studies have demonstrated that poor postnatal weight gain has a negative&#xD;
      effect on neurodevelopment . However, the neurodevelopmental consequences of linear stunting&#xD;
      in this population were not assessed .Understanding this relationship is important because&#xD;
      organ growth and differentiation are more closely linked to lean body mass and thus linear&#xD;
      growth than to weight gain or fat mass alone. Moreover, weight gain and linear growth are not&#xD;
      always tightly linked and may be influenced by both nutritional and non nutritional factors.&#xD;
&#xD;
      Linear growth represents lean body mass and protein accretion and also indexes organ growth&#xD;
      and development, including the brain. American Academy of Pediatrics (AAP) recommends that&#xD;
      preterm infants should grow similar to the fetus,but this guideline has been mostly applied&#xD;
      to weight gain. As already described, the ideal weight gain to optimize neurodevelopmental&#xD;
      outcomes has been studied extensively. However, ideal linear growth has yet to be defined.&#xD;
      Intrauterine linear-growth velocity is approximately 1 cm/wk,and therefore is the goal that&#xD;
      most neonatologists currently follow.Given the increasing evidence that linear-growth&#xD;
      suppression is associated with poorer cognitive outcomes,length may now be an important&#xD;
      anthropometric biomarker for later neurodevelopment. Research is needed to determine optimal&#xD;
      goals of linear growth for preterm infants so as to optimize later growth and&#xD;
      neurodevelopmental outcomes.&#xD;
&#xD;
      Recently the role of neurobehaviour has evaluated as early as at 37-40 weeks of CGA and is&#xD;
      being predicted as an useful adjunct to the 12-18 month full neurodevelopmental assessment&#xD;
      .Neurobehavioural assessment by tools like NAPI have been shown to correlate with BSID score&#xD;
      at 18 months of corrected gestational age in preterm neonates.This has tremendous&#xD;
      implications in terms of initiating an early rehabilitation /stimulation program for these&#xD;
      neonates..&#xD;
&#xD;
      There is insufficient data on Correlation of linear growth and neurological outcome in&#xD;
      preterm VLBW babies in India.With majority of VLBW neonates in India being SGA this assumes&#xD;
      critical significance as growth faltering is reported to continue as late as 24 months&#xD;
      postnatally.The linkage of linear growth faltering and poor neurodevelopmental outcome needs&#xD;
      to be detected early in the India population and corrective strategies need to be instituted&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 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>Association of linear growth on neurobehavioural outcome in preterm neonates</measure>
    <time_frame>18 months</time_frame>
    <description>All preterm neonates born in LHMC who meet the inclusion criteria will be included in the study with in 48 hours of admission .Demographic data, maternal history, labour details and neonatal details will be recorded in the proforma. Length will be measured using a flexible tape measuring tape and a standard infant length board to the nearest 0.1 cm . Length will be measured at time of enrolment,at time of discharge,at 37 weeks and 40 weeks of corrected gestational age.Standardized Z-scores will be calculated for the length and using reference data which included Fenton curves at birth and hospital discharge. Neonates will be evaluated by NAPI score at 37 weeks and 40 weeks of corrected gestational age for neurobehavioural assessment.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>PreTerm Birth</condition>
  <arm_group>
    <arm_group_label>Preterm neonates &lt;34 wks</arm_group_label>
    <description>Haemodynamicaly stable preterm neonates &lt;34 weeks with in 48 hours of admission</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Haemodynamicaly stable preterm neonates &lt;34 weeks with in 48 hours of admission&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infants ( Haemodynamicaly stable preterm neonates &lt;34 weeks with in 48 hours&#xD;
             of admission )&#xD;
&#xD;
          -  Parental Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major congenital malformation&#xD;
&#xD;
          -  Haemodynamic instability&#xD;
&#xD;
          -  Birth asphyxia(Apgar score of less than 7 at 1 minute of age)&#xD;
&#xD;
          -  Multiple gestation.&#xD;
&#xD;
          -  IVH&#xD;
&#xD;
          -  Meningitis&#xD;
&#xD;
          -  Hypoglycemia at admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>40 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vikram Datta, MD,DNB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lady Hardinge Medical College,New Delhi,Delhi,INDIA,110001.</affiliation>
  </overall_official>
  <results_reference>
    <citation>Pfister KM, Ramel SE. Linear growth and neurodevelopmental outcomes. Clin Perinatol. 2014 Jun;41(2):309-21. doi: 10.1016/j.clp.2014.02.004. Epub 2014 Apr 14.</citation>
    <PMID>24873834</PMID>
  </results_reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 12, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>March 16, 2017</last_update_submitted>
  <last_update_submitted_qc>March 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 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>DR. VIKRAM DATTA</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Linear growth and neurodevelopment outcome</keyword>
  <keyword>&lt; 34 weeks</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02970994
org study id: LadyHardinge MC
nct id: NCT02970994
lead sponsor: 
has dmc: Yes
This study will evaluate the association of linear growth on neurobehavioural outcome in
      preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.
Growth of the preterm infant has historically been defined as weight gain over time. As
      weight gain and nutrition have been more extensively studied and their relationships with
      neurodevelopmental outcomes have been established, other growth parameters and their
      relationships to outcome need to be assessed.

      Large multicenteric studies have demonstrated that poor postnatal weight gain has a negative
      effect on neurodevelopment . However, the neurodevelopmental consequences of linear stunting
      in this population were not assessed .Understanding this relationship is important because
      organ growth and differentiation are more closely linked to lean body mass and thus linear
      growth than to weight gain or fat mass alone. Moreover, weight gain and linear growth are not
      always tightly linked and may be influenced by both nutritional and non nutritional factors.

      Linear growth represents lean body mass and protein accretion and also indexes organ growth
      and development, including the brain. American Academy of Pediatrics (AAP) recommends that
      preterm infants should grow similar to the fetus,but this guideline has been mostly applied
      to weight gain. As already described, the ideal weight gain to optimize neurodevelopmental
      outcomes has been studied extensively. However, ideal linear growth has yet to be defined.
      Intrauterine linear-growth velocity is approximately 1 cm/wk,and therefore is the goal that
      most neonatologists currently follow.Given the increasing evidence that linear-growth
      suppression is associated with poorer cognitive outcomes,length may now be an important
      anthropometric biomarker for later neurodevelopment. Research is needed to determine optimal
      goals of linear growth for preterm infants so as to optimize later growth and
      neurodevelopmental outcomes.

      Recently the role of neurobehaviour has evaluated as early as at 37-40 weeks of CGA and is
      being predicted as an useful adjunct to the 12-18 month full neurodevelopmental assessment
      .Neurobehavioural assessment by tools like NAPI have been shown to correlate with BSID score
      at 18 months of corrected gestational age in preterm neonates.This has tremendous
      implications in terms of initiating an early rehabilitation /stimulation program for these
      neonates..

      There is insufficient data on Correlation of linear growth and neurological outcome in
      preterm VLBW babies in India.With majority of VLBW neonates in India being SGA this assumes
      critical significance as growth faltering is reported to continue as late as 24 months
      postnatally.The linkage of linear growth faltering and poor neurodevelopmental outcome needs
      to be detected early in the India population and corrective strategies need to be instituted
observational model: Cohort
time perspective: Prospective
measure: Association of linear growth on neurobehavioural outcome in preterm neonates
time frame: 18 months
description: All preterm neonates born in LHMC who meet the inclusion criteria will be included in the study with in 48 hours of admission .Demographic data, maternal history, labour details and neonatal details will be recorded in the proforma. Length will be measured using a flexible tape measuring tape and a standard infant length board to the nearest 0.1 cm . Length will be measured at time of enrolment,at time of discharge,at 37 weeks and 40 weeks of corrected gestational age.Standardized Z-scores will be calculated for the length and using reference data which included Fenton curves at birth and hospital discharge. Neonates will be evaluated by NAPI score at 37 weeks and 40 weeks of corrected gestational age for neurobehavioural assessment.
arm group label: Preterm neonates <34 wks
description: Haemodynamicaly stable preterm neonates <34 weeks with in 48 hours of admission
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 40 Weeks
healthy volunteers: No
last name: Vikram Datta, MD,DNB
role: Principal Investigator
affiliation: Lady Hardinge Medical College,New Delhi,Delhi,INDIA,110001.
citation: Pfister KM, Ramel SE. Linear growth and neurodevelopmental outcomes. Clin Perinatol. 2014 Jun;41(2):309-21. doi: 10.1016/j.clp.2014.02.004. Epub 2014 Apr 14.
PMID: 24873834
responsible party type: Principal Investigator
investigator affiliation: Lady Hardinge Medical College
investigator full name: DR. VIKRAM DATTA
investigator title: Professor
mesh term: Premature Birth
sharing ipd: Undecided