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.

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Key information

Conditions

Bronchopulmonary Dysplasia Chronic Lung Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

1 day–4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

intubated infants in the Neonatal Intensive Care Unit (NICU)

Exclusion criteria

unwilling or unable to give or obtain informed consent

Treatment and study plan

Primary outcomes

Correlation of serum neurotrophins with development for Bronchopulmonary Dysplasia

Time frame: within 48 hours of Neonatal Intensive Care Unit admission

Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)
Change in serum neurotrophins with developmental delays in children

Time frame: Within 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 years

Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)
Change in serum neurotrophins with respiratory outcomes in children

Time frame: Within 48 hours of Neonatal Intensive Care Unit admission, at 4 months, 1 year and 2 years

Neurotrophins include Nerve Growth Factor (NGF) and Brain-factor Neurotrophic Factor (BDNF)

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Dec 14, 2017
Registry last updated: Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed