<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/NCT03035552</url>
  </required_header>
  <id_info>
    <org_study_id>IRB16-00493</org_study_id>
    <nct_id>NCT03035552</nct_id>
  </id_info>
  <brief_title>CTICU Pacifier Activated Music Player and Mother's Voice</brief_title>
  <official_title>Randomized Controlled Trial to Improve Oral Feeding Outcomes in Infants With Complex Congenital Heart Disease Using Pacifier Activated Device-Training With Mother's Voice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if intensive training of Non-Nutritive Suck (NNS)&#xD;
      using contingent positive reinforcement with mother's voice can improve the feeding outcomes&#xD;
      of infants with congenital heart defect (CHD) at high risk for oral motor problems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized controlled trial to Improve Oral Feeding Outcomes in Infants with Complex&#xD;
      Congenital heart disease using Pacifier Activated Device-Training with Mother's Voice&#xD;
      Specific Aims Infants with complex congenital heart disease (CCHD) have high rates of delayed&#xD;
      or impaired oral feeding skills, associated with other neurodevelopmental problems such as&#xD;
      worse motor and language outcomes in early childhood. The acquisition of efficient suck&#xD;
      strength and patterns is essential to promote later optimal oral feeding. Therefore,&#xD;
      ineffective non-nutritive suck (NNS), one of the earliest feeding milestones, can result in&#xD;
      later maladaptive oral motor skills or even oro-sensory aversions. Evidence-based&#xD;
      interventions are lacking for CCHD infants hospitalized in the Cardiothoracic Intensive Care&#xD;
      Unit (CTICU) to improve early oral feeding patterns and promote acquisition of later&#xD;
      developmental milestones. NNS training (as opposed to simply offering a pacifier) safely&#xD;
      improves oral feeding strength and rate in other high-risk populations, such as preterm&#xD;
      infants, even when they have suffered severe neural insults. This type of training uses&#xD;
      operant conditioning with positive stimuli to reinforce learning and establishment of&#xD;
      functional pathways between lower and higher order neural networks. Furthermore, NNS training&#xD;
      is associated with acquisition of essential developmental milestones in the first year. The&#xD;
      investigators propose the following hypothesis: Intensive NNS-contingent training using&#xD;
      reinforcement with mother's voice can improve the oral feeding outcomes of infants with CCHD.&#xD;
      They further hypothesize that establishment of optimal NNS in the first 6 months can improve&#xD;
      feeding and developmental outcomes by one year of age.&#xD;
&#xD;
      To test this hypothesis, the investigators propose a randomized controlled trial (RCT) in&#xD;
      CCHD infants hospitalized for surgical repair. Because the proposed intervention has been&#xD;
      demonstrated to only have positive effects in other high-risk infants, the study will use a&#xD;
      wait-list design: CCHD infants who do not receive their intervention before surgery will&#xD;
      receive it after, so that the entire cohort will eventually benefit from the intervention.&#xD;
      The intervention will utilize a Pacifier Activated Music Player (PAM) with a sensor detecting&#xD;
      changes in suck pressures and patterns, and a speaker contingently delivering mother's voice,&#xD;
      in infants 0-6 months in the CTICU. Quantitative oral feeding metrics before and after the&#xD;
      intervention, as well as, immediately after discharge will be used to measure efficacy.&#xD;
      Secondly, to assess the impact of NNS training on developmental milestone acquisition, a&#xD;
      standardized feeding and neurodevelopmental assessments of all trial infants at 12 months of&#xD;
      age in the Follow-Up clinic will also be conducted. Randomization will account for&#xD;
      differences in CCHD diagnoses known to impact outcomes. The study design will control for the&#xD;
      type of surgical procedure as a proxy for severity of illness and exposure to anesthesia and&#xD;
      for variables associated with neurodevelopment such as maternal education and prematurity.&#xD;
&#xD;
      Aim 1 A: Compare oral feeding skills as measured by suck strength, rate and burst patterns in&#xD;
      CCHD infants with vs. without NNS training using PAM/mother's voice prior to surgery, in an&#xD;
      RCT design. Aim 1 B: Correlate improvements in oral feeding skills after NNS training with&#xD;
      PAM/mother's voice in the entire study cohort with higher scores on standardized feeding&#xD;
      questionnaires at 1 month after discharge. Aim 2: Demonstrate that improvements in oral&#xD;
      feeding skills in the CTICU will correlate with better neurodevelopmental outcomes as&#xD;
      measured by standardized scores on the Bayley Scales of Infant and Toddler Development (BSID&#xD;
      III) at 12 months. This study holds significant public health relevance as it validates an&#xD;
      inexpensive, parent-centered rehabilitative strategy for infants at high-risk for impaired&#xD;
      oral feeding skills, with a device and approach easily adapted to many levels of CCHD care&#xD;
      and with the potential to improve longer-term neurodevelopment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 15, 2016</start_date>
  <completion_date type="Anticipated">January 31, 2023</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</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>Randomized to Pacifier Activated Lullaby (mother's voice contingent on suck, 15 minutes, 5 sessions) before surgery or and Sounds of Love (mother's voice playing freely, 15 minutes, 5 sessions). Arm 2: Sounds of love before surgery, Pacifier activated lullaby after the surgery.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The assessors and the investigator are masked to the group assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Oral feeding Efficiency</measure>
    <time_frame>Depending on randomization, 5 days pre-operation (group 1) or 5 days post-operation (group 2)</time_frame>
    <description>Continuous measure of suck strength and suck rate during oral feeding via PAM sensor, as well as suck burst pattern and average oral feeding volumes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral feeding development</measure>
    <time_frame>Thirty days post-operation</time_frame>
    <description>Analyzing individual milestones via the American Speech-Language-Hearing Association assessment by speech language pathology, and adverse feeding events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurodevelopment</measure>
    <time_frame>Twelve months</time_frame>
    <description>Evaluating participant's development using Bayley Scales of Infant and Toddler Development (BSID III)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Heart Defects, Congenital</condition>
  <arm_group>
    <arm_group_label>Treatment prior to surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants randomized to receive the pacifier activated music player and mother's voice treatment prior to surgery for 5 sessions, and mother's voice playing freely post surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment post surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants randomized to receive the mother's voice playing freely prior to surgery,and pacifier activated music player and mother's voice treatment post surgery for 5 sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pacifier activated music player</intervention_name>
    <description>Therefore the immediate goal of the current proposal is to demonstrate that intensive NNS-training using reinforcement with mother's voice can improve the oral feeding outcomes of infants with CCHD using a randomized controlled trial (RCT) design, with wait-list controls to ensure that infants in the trial all benefit from a treatment with only demonstrated positive effects. Establishment of optimal NNS patterns in the first 6 months after birth in these infants will improve downstream feeding skills and may promote better motor and language outcomes by one year of age.</description>
    <arm_group_label>Treatment post surgery</arm_group_label>
    <arm_group_label>Treatment prior to surgery</arm_group_label>
    <other_name>PAM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants that have a diagnosis of a complex congenital heart defect and scheduled for a&#xD;
             surgical intervention; meet CTICU feeding guidelines criteria. Infants with acquired&#xD;
             brain injury will be included, as well as those whose mothers speak languages other&#xD;
             than English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants that are on assisted ventilation, continuous positive airway pressure, general&#xD;
             anesthesia within 24 hours; lethal congenital abnormalities or congenital brain&#xD;
             malformation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Months</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathalie Maitre, MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Perinatal Research Institute, Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.</citation>
    <PMID>24446411</PMID>
  </reference>
  <reference>
    <citation>Brosig C, Mussatto K, Hoffman G, Hoffmann RG, Dasgupta M, Tweddell J, Ghanayem N. Neurodevelopmental outcomes for children with hypoplastic left heart syndrome at the age of 5 years. Pediatr Cardiol. 2013 Oct;34(7):1597-604. doi: 10.1007/s00246-013-0679-3. Epub 2013 Mar 16.</citation>
    <PMID>23503929</PMID>
  </reference>
  <reference>
    <citation>Walker K, Badawi N, Halliday R, Stewart J, Sholler GF, Winlaw DS, Sherwood M, Holland AJ. Early developmental outcomes following major noncardiac and cardiac surgery in term infants: a population-based study. J Pediatr. 2012 Oct;161(4):748-752.e1. doi: 10.1016/j.jpeds.2012.03.044. Epub 2012 May 10.</citation>
    <PMID>22578999</PMID>
  </reference>
  <reference>
    <citation>Luyckx K, Missotten L, Goossens E, Moons P; i-DETACH Investigators. Individual and contextual determinants of quality of life in adolescents with congenital heart disease. J Adolesc Health. 2012 Aug;51(2):122-8. doi: 10.1016/j.jadohealth.2011.11.007. Epub 2012 Feb 22.</citation>
    <PMID>22824441</PMID>
  </reference>
  <reference>
    <citation>Cassidy AR, White MT, DeMaso DR, Newburger JW, Bellinger DC. Executive Function in Children and Adolescents with Critical Cyanotic Congenital Heart Disease. J Int Neuropsychol Soc. 2015 Jan;21(1):34-49. doi: 10.1017/S1355617714001027. Epub 2014 Dec 9.</citation>
    <PMID>25487044</PMID>
  </reference>
  <reference>
    <citation>Jackson JL, Misiti B, Bridge JA, Daniels CJ, Vannatta K. Emotional functioning of adolescents and adults with congenital heart disease: a meta-analysis. Congenit Heart Dis. 2015 Jan-Feb;10(1):2-12. doi: 10.1111/chd.12178. Epub 2014 Feb 26.</citation>
    <PMID>24612910</PMID>
  </reference>
  <reference>
    <citation>Adams-Chapman I, Bann CM, Vaucher YE, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association between feeding difficulties and language delay in preterm infants using Bayley Scales of Infant Development-Third Edition. J Pediatr. 2013 Sep;163(3):680-5.e1-3. doi: 10.1016/j.jpeds.2013.03.006. Epub 2013 Apr 10.</citation>
    <PMID>23582139</PMID>
  </reference>
  <reference>
    <citation>Averin K, Uzark K, Beekman RH 3rd, Willging JP, Pratt J, Manning PB. Postoperative assessment of laryngopharyngeal dysfunction in neonates after Norwood operation. Ann Thorac Surg. 2012 Oct;94(4):1257-61. doi: 10.1016/j.athoracsur.2012.01.009. Epub 2012 Mar 14.</citation>
    <PMID>22421593</PMID>
  </reference>
  <reference>
    <citation>Dewan K, Cephus C, Owczarzak V, Ocampo E. Incidence and implication of vocal fold paresis following neonatal cardiac surgery. Laryngoscope. 2012 Dec;122(12):2781-5. doi: 10.1002/lary.23575. Epub 2012 Sep 5.</citation>
    <PMID>22952115</PMID>
  </reference>
  <reference>
    <citation>Sachdeva R, Hussain E, Moss MM, Schmitz ML, Ray RM, Imamura M, Jaquiss RD. Vocal cord dysfunction and feeding difficulties after pediatric cardiovascular surgery. J Pediatr. 2007 Sep;151(3):312-5, 315.e1-2. doi: 10.1016/j.jpeds.2007.03.014. Epub 2007 Jun 26.</citation>
    <PMID>17719946</PMID>
  </reference>
  <reference>
    <citation>Davies RR, Carver SW, Schmidt R, Keskeny H, Hoch J, Pizarro C. Laryngopharyngeal dysfunction independent of vocal fold palsy in infants after aortic arch interventions. J Thorac Cardiovasc Surg. 2014 Aug;148(2):617-24.e2. doi: 10.1016/j.jtcvs.2013.05.054. Epub 2013 Nov 26.</citation>
    <PMID>24290573</PMID>
  </reference>
  <reference>
    <citation>Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45. doi: 10.1067/mpd.2000.109152.</citation>
    <PMID>11060529</PMID>
  </reference>
  <reference>
    <citation>Pereira Kda R, Firpo C, Gasparin M, Teixeira AR, Dornelles S, Bacaltchuk T, Levy DS. Evaluation of swallowing in infants with congenital heart defect. Int Arch Otorhinolaryngol. 2015 Jan;19(1):55-60. doi: 10.1055/s-0034-1384687. Epub 2014 Nov 5.</citation>
    <PMID>25992152</PMID>
  </reference>
  <reference>
    <citation>Skinner ML, Halstead LA, Rubinstein CS, Atz AM, Andrews D, Bradley SM. Laryngopharyngeal dysfunction after the Norwood procedure. J Thorac Cardiovasc Surg. 2005 Nov;130(5):1293-301. doi: 10.1016/j.jtcvs.2005.07.013. Epub 2005 Oct 13.</citation>
    <PMID>16256781</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>May 31, 2022</last_update_submitted>
  <last_update_submitted_qc>May 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Mary Lauren Neel</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Congenital heart disease (CCHD)</keyword>
  <keyword>Non-Nutritive Suck</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Congenital Abnormalities</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/NCT03035552
org study id: IRB16-00493
nct id: NCT03035552
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if intensive training of Non-Nutritive Suck (NNS)
      using contingent positive reinforcement with mother's voice can improve the feeding outcomes
      of infants with congenital heart defect (CHD) at high risk for oral motor problems.
Randomized controlled trial to Improve Oral Feeding Outcomes in Infants with Complex
      Congenital heart disease using Pacifier Activated Device-Training with Mother's Voice
      Specific Aims Infants with complex congenital heart disease (CCHD) have high rates of delayed
      or impaired oral feeding skills, associated with other neurodevelopmental problems such as
      worse motor and language outcomes in early childhood. The acquisition of efficient suck
      strength and patterns is essential to promote later optimal oral feeding. Therefore,
      ineffective non-nutritive suck (NNS), one of the earliest feeding milestones, can result in
      later maladaptive oral motor skills or even oro-sensory aversions. Evidence-based
      interventions are lacking for CCHD infants hospitalized in the Cardiothoracic Intensive Care
      Unit (CTICU) to improve early oral feeding patterns and promote acquisition of later
      developmental milestones. NNS training (as opposed to simply offering a pacifier) safely
      improves oral feeding strength and rate in other high-risk populations, such as preterm
      infants, even when they have suffered severe neural insults. This type of training uses
      operant conditioning with positive stimuli to reinforce learning and establishment of
      functional pathways between lower and higher order neural networks. Furthermore, NNS training
      is associated with acquisition of essential developmental milestones in the first year. The
      investigators propose the following hypothesis: Intensive NNS-contingent training using
      reinforcement with mother's voice can improve the oral feeding outcomes of infants with CCHD.
      They further hypothesize that establishment of optimal NNS in the first 6 months can improve
      feeding and developmental outcomes by one year of age.

      To test this hypothesis, the investigators propose a randomized controlled trial (RCT) in
      CCHD infants hospitalized for surgical repair. Because the proposed intervention has been
      demonstrated to only have positive effects in other high-risk infants, the study will use a
      wait-list design: CCHD infants who do not receive their intervention before surgery will
      receive it after, so that the entire cohort will eventually benefit from the intervention.
      The intervention will utilize a Pacifier Activated Music Player (PAM) with a sensor detecting
      changes in suck pressures and patterns, and a speaker contingently delivering mother's voice,
      in infants 0-6 months in the CTICU. Quantitative oral feeding metrics before and after the
      intervention, as well as, immediately after discharge will be used to measure efficacy.
      Secondly, to assess the impact of NNS training on developmental milestone acquisition, a
      standardized feeding and neurodevelopmental assessments of all trial infants at 12 months of
      age in the Follow-Up clinic will also be conducted. Randomization will account for
      differences in CCHD diagnoses known to impact outcomes. The study design will control for the
      type of surgical procedure as a proxy for severity of illness and exposure to anesthesia and
      for variables associated with neurodevelopment such as maternal education and prematurity.

      Aim 1 A: Compare oral feeding skills as measured by suck strength, rate and burst patterns in
      CCHD infants with vs. without NNS training using PAM/mother's voice prior to surgery, in an
      RCT design. Aim 1 B: Correlate improvements in oral feeding skills after NNS training with
      PAM/mother's voice in the entire study cohort with higher scores on standardized feeding
      questionnaires at 1 month after discharge. Aim 2: Demonstrate that improvements in oral
      feeding skills in the CTICU will correlate with better neurodevelopmental outcomes as
      measured by standardized scores on the Bayley Scales of Infant and Toddler Development (BSID
      III) at 12 months. This study holds significant public health relevance as it validates an
      inexpensive, parent-centered rehabilitative strategy for infants at high-risk for impaired
      oral feeding skills, with a device and approach easily adapted to many levels of CCHD care
      and with the potential to improve longer-term neurodevelopment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized to Pacifier Activated Lullaby (mother's voice contingent on suck, 15 minutes, 5 sessions) before surgery or and Sounds of Love (mother's voice playing freely, 15 minutes, 5 sessions). Arm 2: Sounds of love before surgery, Pacifier activated lullaby after the surgery.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: The assessors and the investigator are masked to the group assignment
measure: Oral feeding Efficiency
time frame: Depending on randomization, 5 days pre-operation (group 1) or 5 days post-operation (group 2)
description: Continuous measure of suck strength and suck rate during oral feeding via PAM sensor, as well as suck burst pattern and average oral feeding volumes.
measure: Oral feeding development
time frame: Thirty days post-operation
description: Analyzing individual milestones via the American Speech-Language-Hearing Association assessment by speech language pathology, and adverse feeding events.
measure: Neurodevelopment
time frame: Twelve months
description: Evaluating participant's development using Bayley Scales of Infant and Toddler Development (BSID III)
arm group label: Treatment prior to surgery
arm group type: Experimental
description: Infants randomized to receive the pacifier activated music player and mother's voice treatment prior to surgery for 5 sessions, and mother's voice playing freely post surgery.
arm group label: Treatment post surgery
arm group type: Experimental
description: Infants randomized to receive the mother's voice playing freely prior to surgery,and pacifier activated music player and mother's voice treatment post surgery for 5 sessions.
intervention type: Behavioral
intervention name: Pacifier activated music player
description: Therefore the immediate goal of the current proposal is to demonstrate that intensive NNS-training using reinforcement with mother's voice can improve the oral feeding outcomes of infants with CCHD using a randomized controlled trial (RCT) design, with wait-list controls to ensure that infants in the trial all benefit from a treatment with only demonstrated positive effects. Establishment of optimal NNS patterns in the first 6 months after birth in these infants will improve downstream feeding skills and may promote better motor and language outcomes by one year of age.
arm group label: Treatment post surgery
arm group label: Treatment prior to surgery
other name: PAM
criteria: 
gender: All
minimum age: 0 Months
maximum age: 6 Months
healthy volunteers: No
last name: Nathalie Maitre, MD. PhD
role: Principal Investigator
affiliation: Perinatal Research Institute, Nationwide Children's Hospital
facility: 
country: United States
citation: Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.
PMID: 24446411
citation: Brosig C, Mussatto K, Hoffman G, Hoffmann RG, Dasgupta M, Tweddell J, Ghanayem N. Neurodevelopmental outcomes for children with hypoplastic left heart syndrome at the age of 5 years. Pediatr Cardiol. 2013 Oct;34(7):1597-604. doi: 10.1007/s00246-013-0679-3. Epub 2013 Mar 16.
PMID: 23503929
citation: Walker K, Badawi N, Halliday R, Stewart J, Sholler GF, Winlaw DS, Sherwood M, Holland AJ. Early developmental outcomes following major noncardiac and cardiac surgery in term infants: a population-based study. J Pediatr. 2012 Oct;161(4):748-752.e1. doi: 10.1016/j.jpeds.2012.03.044. Epub 2012 May 10.
PMID: 22578999
citation: Luyckx K, Missotten L, Goossens E, Moons P; i-DETACH Investigators. Individual and contextual determinants of quality of life in adolescents with congenital heart disease. J Adolesc Health. 2012 Aug;51(2):122-8. doi: 10.1016/j.jadohealth.2011.11.007. Epub 2012 Feb 22.
PMID: 22824441
citation: Cassidy AR, White MT, DeMaso DR, Newburger JW, Bellinger DC. Executive Function in Children and Adolescents with Critical Cyanotic Congenital Heart Disease. J Int Neuropsychol Soc. 2015 Jan;21(1):34-49. doi: 10.1017/S1355617714001027. Epub 2014 Dec 9.
PMID: 25487044
citation: Jackson JL, Misiti B, Bridge JA, Daniels CJ, Vannatta K. Emotional functioning of adolescents and adults with congenital heart disease: a meta-analysis. Congenit Heart Dis. 2015 Jan-Feb;10(1):2-12. doi: 10.1111/chd.12178. Epub 2014 Feb 26.
PMID: 24612910
citation: Adams-Chapman I, Bann CM, Vaucher YE, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association between feeding difficulties and language delay in preterm infants using Bayley Scales of Infant Development-Third Edition. J Pediatr. 2013 Sep;163(3):680-5.e1-3. doi: 10.1016/j.jpeds.2013.03.006. Epub 2013 Apr 10.
PMID: 23582139
citation: Averin K, Uzark K, Beekman RH 3rd, Willging JP, Pratt J, Manning PB. Postoperative assessment of laryngopharyngeal dysfunction in neonates after Norwood operation. Ann Thorac Surg. 2012 Oct;94(4):1257-61. doi: 10.1016/j.athoracsur.2012.01.009. Epub 2012 Mar 14.
PMID: 22421593
citation: Dewan K, Cephus C, Owczarzak V, Ocampo E. Incidence and implication of vocal fold paresis following neonatal cardiac surgery. Laryngoscope. 2012 Dec;122(12):2781-5. doi: 10.1002/lary.23575. Epub 2012 Sep 5.
PMID: 22952115
citation: Sachdeva R, Hussain E, Moss MM, Schmitz ML, Ray RM, Imamura M, Jaquiss RD. Vocal cord dysfunction and feeding difficulties after pediatric cardiovascular surgery. J Pediatr. 2007 Sep;151(3):312-5, 315.e1-2. doi: 10.1016/j.jpeds.2007.03.014. Epub 2007 Jun 26.
PMID: 17719946
citation: Davies RR, Carver SW, Schmidt R, Keskeny H, Hoch J, Pizarro C. Laryngopharyngeal dysfunction independent of vocal fold palsy in infants after aortic arch interventions. J Thorac Cardiovasc Surg. 2014 Aug;148(2):617-24.e2. doi: 10.1016/j.jtcvs.2013.05.054. Epub 2013 Nov 26.
PMID: 24290573
citation: Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45. doi: 10.1067/mpd.2000.109152.
PMID: 11060529
citation: Pereira Kda R, Firpo C, Gasparin M, Teixeira AR, Dornelles S, Bacaltchuk T, Levy DS. Evaluation of swallowing in infants with congenital heart defect. Int Arch Otorhinolaryngol. 2015 Jan;19(1):55-60. doi: 10.1055/s-0034-1384687. Epub 2014 Nov 5.
PMID: 25992152
citation: Skinner ML, Halstead LA, Rubinstein CS, Atz AM, Andrews D, Bradley SM. Laryngopharyngeal dysfunction after the Norwood procedure. J Thorac Cardiovasc Surg. 2005 Nov;130(5):1293-301. doi: 10.1016/j.jtcvs.2005.07.013. Epub 2005 Oct 13.
PMID: 16256781
responsible party type: Principal Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Mary Lauren Neel
investigator title: MD, PhD
mesh term: Heart Defects, Congenital
mesh term: Congenital Abnormalities
sharing ipd: No