Brief Title
Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes
Official Title
Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes
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.
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
Primary Outcome
Correlation of serum neurotrophins with development for Bronchopulmonary Dysplasia
Condition
Bronchopulmonary Dysplasia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
70
Start Date
December 2014
Completion Date
August 2019
Primary Completion Date
August 2019
Eligibility Criteria
Inclusion Criteria:
intubated infants in the Neonatal Intensive Care Unit (NICU)
Exclusion Criteria:
unwilling or unable to give or obtain informed consent
Gender
All
Ages
1 Day - 4 Months
Accepts Healthy Volunteers
No
Contacts
Giovanni Piedimonte, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03373539
Organization ID
14-1270
Responsible Party
Principal Investigator
Study Sponsor
The Cleveland Clinic
Study Sponsor
Giovanni Piedimonte, MD, Principal Investigator, The Cleveland Clinic
Verification Date
August 2019