Reading for Infant, Premature, Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Virginia, Charlottesville, VA
Infant, Premature, Diseases+1 More
reading - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

The purpose of this study is to learn how early language exposure may be related to changes in DNA in parents and their premature infants. While a person's genetic code is determined at the time of conception, the way that some genes are expressed in the body can be changed even after an individual is born. These changes are called epigenetic changes. In this study, the investigators want to learn about the epigenetic changes that happen after a premature baby is born and whether a parent's interaction with their baby can influence these epigenetic changes. The investigators will look at epigenetic changes by collecting saliva samples from parents and their preterm babies, here defined as babies born at <32 weeks gestation. Specifically, the investigators will be looking at salivary levels of DNA methylation of the oxytocin receptor gene (OXTRm). The investigators will track changes in OXTRm levels over time in parents and their babies and see if these levels change in relation to how much time parents spend with their babies and how much time they spend reading to their babies. The investigators will ask mothers and, if desired, their partners to read to their babies for at least 15 minutes per week. The investigators will ask them to track time spent with the baby and reading time on a log, and will also measure word count with a commercially-available LENA device. The investigators will use logistic regression analysis to identify the independent association between OXTR DNA methylation and time spent with parent(s) and word count.

Eligible Conditions

  • Infant, Premature, Diseases
  • Infant Development

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Birth to discharge from neonatal intensive care unit (approximately 1-4 months)

Month 4
Parental anxiety
Parental depression
Parental stress
Salivary oxytocin receptor gene DNA methylation (OXTRm)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Reading
1 of 1
Experimental Treatment

90 Total Participants · 1 Treatment Group

Primary Treatment: Reading · No Placebo Group · N/A

Reading
Behavioral
Experimental Group · 1 Intervention: reading · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: birth to discharge from neonatal intensive care unit (approximately 1-4 months)

Trial Background

Kelsey Sullivan, MD
Principal Investigator
University of Virginia
Closest Location: University of Virginia · Charlottesville, VA
Photo of university of virginia  1Photo of university of virginia  2Photo of university of virginia  3
2004First Recorded Clinical Trial
1 TrialsResearching Infant, Premature, Diseases
526 CompletedClinical Trials

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a mother or primary caregiver
You must be at least 18 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References