Clinical trial NCT03373539: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Chronic Lung Disease
Keywords: Biomarkers
Neurotrophins
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: neonates in Neonatal Intensive Care Unit (NICU)

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.

Eligibility criteria: Inclusion Criteria:

intubated infants in the Neonatal Intensive Care Unit (NICU)

Exclusion Criteria:

unwilling or unable to give or obtain informed consent

Primary outcomes:
measure: Correlation of serum neurotrophins with development for Bronchopulmonary Dysplasia
timeFrame: within 48 hours of Neonatal Intensive Care Unit admission
measure: Change in serum neurotrophins with developmental delays in children
timeFrame: Within 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 years
measure: Change in serum neurotrophins with respiratory outcomes in children
timeFrame: Within 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Giovanni Piedimonte, MD
role: PRINCIPAL_INVESTIGATOR
References: