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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Lung Disease; Bronchopulmonary Dysplasia

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
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

neonates in Neonatal Intensive Care Unit (NICU)

Description

Inclusion Criteria:

intubated infants in the Neonatal Intensive Care Unit (NICU)

Exclusion Criteria:

unwilling or unable to give or obtain informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Giovanni Piedimonte, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Biomarkers; Neurotrophins
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Lung Diseases; Bronchopulmonary Dysplasia
• Other Study ID Numbers: 14-1270

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No