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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373539
• Other study ID #: 14-1270
• Status: Completed
• Start date: December 2014
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

Inclusion Criteria:

intubated infants in the Neonatal Intensive Care Unit (NICU)

Exclusion Criteria:

unwilling or unable to give or obtain informed consent

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Chronic Lung Disease
• Lung Diseases

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of serum neurotrophins with development for Bronchopulmonary Dysplasia	Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)	within 48 hours of Neonatal Intensive Care Unit admission
Primary	Change in serum neurotrophins with developmental delays in children	Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)	Within 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 years
Primary	Change in serum neurotrophins with respiratory outcomes in children	Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)	Within 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 years