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Behavioral Intervention

Reading for Premature Infant Development

Q: Is this clinical trial currently recruiting participants?

<p>Clinicaltrials.gov shows that this trial is no longer recruiting, even though it was first posted on August 1st 2022 and last edited in June 7th 2022. However, 44 other studies are currently enrolling patients at the present time.</p>

N/A

Recruiting

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infants <32 week gestational age at birth

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth to discharge from neonatal intensive care unit (approximately 1-4 months)

Awards & highlights

Study Summary

This trial is looking at how a baby's genes change after they're born, and whether a parent's interaction with their baby can influence these changes.

Who is the study for?

This trial is for preterm infants born at less than 33 weeks gestation. Their mothers, or primary caregivers, must be able to visit at least once a week and commit to reading for a minimum of 15 minutes weekly. Fathers or secondary caregivers can also participate. Non-English speaking mothers, those who are illiterate, or infants with life-limiting conditions cannot join.Check my eligibility

What is being tested?

The study investigates how parent-infant interactions like reading affect epigenetic changes in premature babies' DNA related to the oxytocin receptor gene (OXTRm). Parents will read to their infant and track time spent together; saliva samples from both will be analyzed over time.See study design

What are the potential side effects?

Since this trial involves reading activities rather than medical interventions, there are no direct side effects associated with traditional clinical trials. However, it's important to consider the emotional impact on parents and infants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was born before 32 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ birth to discharge from neonatal intensive care unit (approximately 1-4 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~birth to discharge from neonatal intensive care unit (approximately 1-4 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to discharge from neonatal intensive care unit (approximately 1-4 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Salivary oxytocin receptor gene DNA methylation (OXTRm)

Secondary outcome measures

Parental anxiety

Parental depression

Parental stress

Trial Design

1Treatment groups

Experimental Treatment

Group I: ReadingExperimental Treatment1 Intervention

Mother and, if desired, mother's partner will read to infant for at least 15 minutes per week, but will be encouraged to read to infant as much as possible. Saliva will be collected from infants and parents for OXTRm assay at pre-specified time points, and at these time point parents will also complete standardized questionnaires including PSS-NICU, PROMIS depression, and PROMIS anxiety to assess parental mood and stress. Reading time will be measured with a reading log provided to the parents, as well as with a commercially-available LENA device to measure word count.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,244,941 Total Patients Enrolled

Media Library

Reading (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05412524 — N/A

Infant Development Research Study Groups: Reading

Infant Development Clinical Trial 2023: Reading Highlights & Side Effects. Trial Name: NCT05412524 — N/A

Reading (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05412524 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently recruiting participants?

"Clinicaltrials.gov shows that this trial is no longer recruiting, even though it was first posted on August 1st 2022 and last edited in June 7th 2022. However, 44 other studies are currently enrolling patients at the present time."

Answered by AI

Recent research and studies

PediatricsJournal

Importance of Parent Talk on the Development of Preterm Infant Vocalizations

Caskey, Melinda, Bonnie Stephens, Richard Tucker, and Betty Vohr. 2011. “Importance of Parent Talk on the Development of Preterm Infant Vocalizations”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2011-0609.

Science AdvancesJournal

Epigenetic Dynamics in Infancy and the Impact of Maternal Engagement

Krol, Kathleen M., Robert G. Moulder, Travis S. Lillard, Tobias Grossmann, and Jessica J. Connelly. 2019. “Epigenetic Dynamics in Infancy and the Impact of Maternal Engagement”. Science Advances. American Association for the Advancement of Science (AAAS). doi:10.1126/sciadv.aay0680.

PsychoneuroendocrinologyJournal

Early Nurture Epigenetically Tunes the Oxytocin Receptor

Perkeybile, Allison M., C. Sue Carter, Kelly L. Wroblewski, Meghan H. Puglia, William M. Kenkel, Travis S. Lillard, Themistoclis Karaoli, et al.. 2019. “Early Nurture Epigenetically Tunes the Oxytocin Receptor”. Psychoneuroendocrinology. Elsevier BV. doi:10.1016/j.psyneuen.2018.08.037.

PediatricsJournal