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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03373539
Enrollment
70
Registered
2017-12-14
Start date
2014-12-31
Completion date
2019-08-31
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia, Chronic Lung Disease

Keywords

Biomarkers, Neurotrophins

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.

Interventions

None listed

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 4 Months
Healthy volunteers
No

Inclusion criteria

intubated infants in the Neonatal Intensive Care Unit (NICU)

Exclusion criteria

unwilling or unable to give or obtain informed consent

Design outcomes

Primary

MeasureTime frameDescription
Correlation of serum neurotrophins with development for Bronchopulmonary Dysplasiawithin 48 hours of Neonatal Intensive Care Unit admissionNeurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)
Change in serum neurotrophins with developmental delays in childrenWithin 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 yearsNeurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)
Change in serum neurotrophins with respiratory outcomes in childrenWithin 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 yearsNeurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026