Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT05412524

Conditions

Premature Infant Disease

Development, Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

reading

Study Details

Brief 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 <33 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.

Conditions

Premature Infant Disease

Development, Infant

Study ID

NCT05412524

Start date

Sep 23, 2022

Status verified date

May, 2023

Completion date

Apr, 2024

Anticipated

Primary completion date

Apr, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Infants <33 week gestational age at birth
  • Mother must be able to visit at least once per week
  • Mother or primary caregiver must participate; father or secondary caregiver may participate as well
  • Mother must commit to minimum of 15 minutes reading at least once per week

Exclusion Criteria:

  • Infant with life-limiting conditions
  • Mother is non-English speaking
  • Illiteracy of mother

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Reading

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.

Interventions

reading

Mothers and, if desired, mother's partner will read to preterm infant as frequently and as much as they are able to. Reading is the intervention. The variable of interest is parents' and infants' change in salivary oxytocin receptor gene methylation (OXTRm) over time.

Primary outcome measure

  • Salivary oxytocin receptor gene DNA methylation (OXTRm) [ Time Frame: Birth to discharge from neonatal intensive care unit (approximately 1-4 months) ]

Central Contacts and Locations

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

More Information

Sponsor

University of Virginia

Last update posted

May 17, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2023-05-17.