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Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes

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ClinicalTrials.gov Identifier: NCT03373539
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Giovanni Piedimonte, The Cleveland Clinic

Brief Summary:

Important developmental processes continue until the completion of 40 weeks gestation. Even during fetal life, intrinsic and environmental factors determine the balance between health and the onset and development of diseases. Thus, it is crucial to understand the mechanisms that regulate normal development and the pathways that contribute to disease pathogenesis.

Neurotrophins are a family of four proteins that support the growth and survival of neurons. Their secretion increases during brain development, when new neurons are being formed and existing ones are branching to assemble complex neuronal circuits. In addition to their role in promoting neuron growth and development, neurotrophins are also a product of neuronal activity. Neurotrophins are also responsible for the maintenance of peripheral sensory neurons, including those in the lungs. Airway innervation is responsible for many aspects of lung function including the regulation of airway smooth muscle tone, mucus secretion, and reactivity; therefore, a physiological expression of neurotrophins in the lungs is required for normal lung function.


Condition or disease
Bronchopulmonary Dysplasia Chronic Lung Disease

Detailed Description:
Currently, there is no reliable method to identify infants who will have poor neurodevelopmental and respiratory outcomes. The ability to make such predictions would be beneficial for both making care decisions in the neonatal intensive care unit and for identifying infants who require earlier and more intense intervention. We intend to determine if neurotrophins can be utilized to predict an infant's long-term outcomes. Neurotrophins are a family of four proteins that support the growth and survival of neurons. Their levels have been shown to increase with brain development and decrease with brain injury. Neurotrophins have also been associated with development of airway injury in the neonate and later respiratory disease such as asthma. We plan to correlate serum neurotrophin levels with respiratory outcomes and neurological outcomes.

Study Type : Observational
Estimated Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes
Actual Study Start Date : December 2014
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Correlation of serum neurotrophins with development for Bronchopulmonary Dysplasia [ Time Frame: within 48 hours of Neonatal Intensive Care Unit admission ]
    Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)

  2. Change in serum neurotrophins with developmental delays in children [ Time Frame: Within 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 years ]
    Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)

  3. Change in serum neurotrophins with respiratory outcomes in children [ Time Frame: Within 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 years ]
    Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)


Biospecimen Retention:   Samples Without DNA
Blood


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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
neonates in Neonatal Intensive Care Unit (NICU)
Criteria

Inclusion Criteria:

intubated infants in the Neonatal Intensive Care Unit (NICU)

Exclusion Criteria:

unwilling or unable to give or obtain informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373539


Contacts
Contact: Giovanni Piedimonte, MD 216-444-3905 PIEDIMG@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Giovanni Piedimonte, MD    216-444-3905    PIEDIMG@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Giovanni Piedimonte, MD The Cleveland Clinic

Responsible Party: Giovanni Piedimonte, Director, Center for Pediatric Research, Lerner Research Institute, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03373539     History of Changes
Other Study ID Numbers: 14-1270
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giovanni Piedimonte, The Cleveland Clinic:
Biomarkers
Neurotrophins

Additional relevant MeSH terms:
Lung Diseases
Bronchopulmonary Dysplasia
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases