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Impact of Reading on Endogenous Oxytocin System of Preterm Infants

Primary Purpose

Premature Infant Disease, Development, Infant

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
reading
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Infant Disease

Eligibility Criteria

undefined - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants <32 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

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reading

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Parental stress
Parental stress, as measured by PSS-NICU, and its correlation with amount of time parents spend reading to infants
Parental depression
Parental stress, as measured by the PROMIS depression short form, and its correlation with amount of time parents spend reading to infants
Parental anxiety
Parental stress, as measured by the PROMIS anxiety scale, and its correlation with amount of time parents spend reading to infants

Full Information

First Posted
May 10, 2022
Last Updated
May 15, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT05412524
Brief Title
Impact of Reading on Endogenous Oxytocin System of Preterm Infants
Official Title
Impact of Reading on Endogenous Oxytocin System of Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Student's t-test and Pearson's chi-square tests will be used to compare continuous and categorical variables, respectively. Logistic regression analysis will used to identify the independent association between OXTR DNA methylation and time spent with parent(s) and word count. Variables with p≤0.20 in the univariate analysis will be entered into a stepwise logistic multivariate regression model. Odds ratios with 95% confidence intervals will be calculated. p value of less than 0.05 will be considered statistically significant. A protocol modification was submitted to and approved by the University of Virginia IRB due to slower than expected participant enrollment. The protocol was modified such that: Enrollment of <33 week instead of <32 week infants was permitted Enrollment was permitted through the first 2 weeks after birth instead of through the first 1 week after birth

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant Disease, Development, Infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reading
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
reading
Intervention Description
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 Information:
Title
Salivary oxytocin receptor gene DNA methylation (OXTRm)
Description
Salivary oxytocin receptor gene DNA methylation (OXTRm), change in time as related to amount of time parents spend reading to infant
Time Frame
Birth to discharge from neonatal intensive care unit (approximately 1-4 months)
Secondary Outcome Measure Information:
Title
Parental stress
Description
Parental stress, as measured by PSS-NICU, and its correlation with amount of time parents spend reading to infants
Time Frame
Birth to discharge from neonatal intensive care unit (approximately 1-4 months)
Title
Parental depression
Description
Parental stress, as measured by the PROMIS depression short form, and its correlation with amount of time parents spend reading to infants
Time Frame
Birth to discharge from neonatal intensive care unit (approximately 1-4 months)
Title
Parental anxiety
Description
Parental stress, as measured by the PROMIS anxiety scale, and its correlation with amount of time parents spend reading to infants
Time Frame
Birth to discharge from neonatal intensive care unit (approximately 1-4 months)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Sullivan, MD
Phone
434-305-9356
Email
ptf3df@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Santina Zanelli, MD
Phone
434-924-2335
Email
SZ5D@hscmail.mcc.virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30227351
Citation
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.
Results Reference
background
PubMed Identifier
24515512
Citation
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.
Results Reference
background
PubMed Identifier
31663028
Citation
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.
Results Reference
background
PubMed Identifier
22007020
Citation
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.
Results Reference
background
PubMed Identifier
34769878
Citation
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.
Results Reference
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Impact of Reading on Endogenous Oxytocin System of Preterm Infants

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