Impact of Reading on Endogenous Oxytocin System of Preterm Infants

NCT05412524 | Unknown

• 1 other identifier: HSR220058
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Salivary oxytocin receptor gene DNA methylation (OXTRm)

  Salivary oxytocin receptor gene DNA methylation (OXTRm), change in time as related to amount of time parents spend reading to infant

  Birth to discharge from neonatal intensive care unit (approximately 1-4 months)

Secondary Outcomes (3)

• Parental stress

  Birth to discharge from neonatal intensive care unit (approximately 1-4 months)

• Parental depression

  Birth to discharge from neonatal intensive care unit (approximately 1-4 months)

• Parental anxiety

  Birth to discharge from neonatal intensive care unit (approximately 1-4 months)

Study Arms (1)

Reading

EXPERIMENTAL

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.

Behavioral: reading

Interventions

reading BEHAVIORAL

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.

Reading

Eligibility Criteria

• Age: Up to 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Related Publications (5)

• Perkeybile AM, Carter CS, Wroblewski KL, Puglia MH, Kenkel WM, Lillard TS, Karaoli T, Gregory SG, Mohammadi N, Epstein L, Bales KL, Connelly JJ. Early nurture epigenetically tunes the oxytocin receptor. Psychoneuroendocrinology. 2019 Jan;99:128-136. doi: 10.1016/j.psyneuen.2018.08.037. Epub 2018 Aug 31.

  PMID: 30227351 BACKGROUND

• Caskey M, Stephens B, Tucker R, Vohr B. Adult talk in the NICU with preterm infants and developmental outcomes. Pediatrics. 2014 Mar;133(3):e578-84. doi: 10.1542/peds.2013-0104. Epub 2014 Feb 10.

  PMID: 24515512 BACKGROUND

• Krol KM, Moulder RG, Lillard TS, Grossmann T, Connelly JJ. Epigenetic dynamics in infancy and the impact of maternal engagement. Sci Adv. 2019 Oct 16;5(10):eaay0680. doi: 10.1126/sciadv.aay0680. eCollection 2019 Oct.

  PMID: 31663028 BACKGROUND

• Caskey M, Stephens B, Tucker R, Vohr B. Importance of parent talk on the development of preterm infant vocalizations. Pediatrics. 2011 Nov;128(5):910-6. doi: 10.1542/peds.2011-0609. Epub 2011 Oct 17.

  PMID: 22007020 BACKGROUND

• Neri E, De Pascalis L, Agostini F, Genova F, Biasini A, Stella M, Trombini E. Parental Book-Reading to Preterm Born Infants in NICU: The Effects on Language Development in the First Two Years. Int J Environ Res Public Health. 2021 Oct 29;18(21):11361. doi: 10.3390/ijerph182111361.

  PMID: 34769878 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 4th Year Resident, Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: June 9, 2022
• Study Start: September 23, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)