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

NCT03373539 | Completed

• 1 other identifier: 14-1270
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia; Chronic Lung Disease

Keywords

Biomarkers; Neurotrophins

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 1 Day - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

neonates in Neonatal Intensive Care Unit (NICU)

You may qualify if:

• intubated infants in the Neonatal Intensive Care Unit (NICU)

You may not qualify if:

• unwilling or unable to give or obtain informed consent

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Giovanni Piedimonte, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 14, 2017
• Study Start: December 1, 2014
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 26, 2025

Record last verified: 2019-08

Locations

US (1)