NCT03688386

Brief Summary

This is a randomized controlled trial to study a reading intervention in the NICU among preterm infants using LENA (Language Environment Analysis) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient language environment and language outcomes for preterm infants.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 4, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

June 18, 2018

Last Update Submit

October 6, 2020

Conditions

Language DevelopmentLanguage DelayMother-Infant InteractionMaternal Behavior

Keywords

Language interventionPreterm readingHeart rate variabilityMother-infant interactionNICU Network Neurobehavioral ScaleLENA

Outcome Measures

Primary Outcomes (1)

  • LENA Counts

    Adult word counts, conversational turns, and infant vocalizations from each recording

    Change from 32 week language counts to 36 week language counts

Secondary Outcomes (4)

  • Neonatal Intensive Care Unit Network Neurobehavioral Scale profile

    36 weeks

  • Bayley Scales of Infant and Toddler Development, Third Edition

    12 months and 24 months

  • Maternal Well-Being

    36 weeks

  • Perception of reading and infant bonding

    36 weeks and 12 months

Other Outcomes (1)

  • DNA methylation

    Enrollment and 36 weeks

Study Arms (2)

Language Intervention

EXPERIMENTAL

1\. Review language and infant bonding curriculum 2. 1st LENA recording and heart rate variability of mother reading to infant 3. Provide LENA linguistic feedback and review curriculum 4. 2nd LENA recording and heart rate variability of mother reading to infant 5. Provide LENA linguistic feedback and review curriculum 6. 3rd LENA recording and heart rate variability of mother reading to infant 7. Provide LENA linguistic feedback Assessments: 1. NICU Network Neurobehavioral Scale (NNNS) profile at 36 weeks 2. Fragile Infant Parent Readiness Evaluation at 36 weeks 3. Parent perception survey of reading and curriculum at 36 weeks and 12 months 4. Bayley Scales of Infant and Toddler Development at 12 and 24 months 5. DNA methylation of genes pre and post intervention

Behavioral: Reading interventionBehavioral: Infant bondingBehavioral: LENA recordingBehavioral: LENA linguistic feedback

Infant bonding

ACTIVE COMPARATOR

1\. Review infant bonding curriculum with mother 2. 1st LENA recording and heart rate variability of mother holding infant 3. Review infant bonding curriculum 4. 2nd LENA recording and heart rate variability of mother holding infant 5. Review infant bonding curriculum 6. 3rd LENA recording and heart rate variability of mother holding infant 7. Provide linguistic feedback of all 3 LENA recordings Assessments: 1. NICU Network Neurobehavioral Scale (NNNS) profile at 36 weeks 2. Fragile Infant Parent Readiness Evaluation at 36 weeks 3. Parent perception survey of reading and curriculum at 36 weeks and 12 months 4. Bayley Scales of Infant and Toddler Development at 12 and 24 months 5. DNA methylation of genes pre and post intervention

Behavioral: Infant bondingBehavioral: LENA recordingBehavioral: LENA summary

Interventions

Reading interventionBEHAVIORAL

Written packet with 3 lessons. The first lesson includes how to begin to read and talk to their baby. The second lesson includes reading or talking about the day using parentese talk. The third lesson includes continuing to engage with the baby through interactive reading.

Language Intervention
Infant bondingBEHAVIORAL

Written packet with 3 lessons. The first lesson includes skin-to-skin and learning about their baby. The second lesson includes learning readiness cues and participation in feeding times. The third lesson includes developing routines and playing games.

Infant bondingLanguage Intervention
LENA recordingBEHAVIORAL

The LENA device provide 16 hours of language recordings placed inside an infant vest. The recordings are uploaded to a computer which analyzes total adult word counts, infant vocalizations, conversational turns, background noise, and silence.

Infant bondingLanguage Intervention
LENA linguistic feedbackBEHAVIORAL

LENA recordings of adult word counts, infant vocalizations, and conversational turns will be provided in printed form after each recording with review of each recording and progress over time.

Language Intervention
LENA summaryBEHAVIORAL

All 3 LENA recording summaries of adult word counts, infant vocalizations, and conversational turns will be summarized in printed form and provided to mother at discharge.

Infant bonding

Eligibility Criteria

Age23 Weeks - 31 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • week infants, medically stable infants, English speaking mothers over 18 years old

You may not qualify if:

  • Intubated or medically unstable, major congenital anomalies, non English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02903, United States

Location

Related Publications (4)

  • Feldman R, Magori-Cohen R, Galili G, Singer M, Louzoun Y. Mother and infant coordinate heart rhythms through episodes of interaction synchrony. Infant Behav Dev. 2011 Dec;34(4):569-77. doi: 10.1016/j.infbeh.2011.06.008. Epub 2011 Jul 20.

    PMID: 21767879BACKGROUND

  • Lester BM, Marsit CJ, Giarraputo J, Hawes K, LaGasse LL, Padbury JF. Neurobehavior related to epigenetic differences in preterm infants. Epigenomics. 2015 Oct;7(7):1123-36. doi: 10.2217/epi.15.63. Epub 2015 Nov 20.

    PMID: 26585459BACKGROUND

  • Lariviere J, Rennick JE. Parent picture-book reading to infants in the neonatal intensive care unit as an intervention supporting parent-infant interaction and later book reading. J Dev Behav Pediatr. 2011 Feb-Mar;32(2):146-52. doi: 10.1097/DBP.0b013e318203e3a1.

    PMID: 21289497BACKGROUND

  • 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: 24515512RESULT

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Betty Vohr, MD

    Women and Infants Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomization of mother infant pairs to a language curriculum with reading (intervention) or an infant bonding curriculum (control)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2018

First Posted

September 28, 2018

Study Start

December 4, 2018

Primary Completion

March 3, 2020

Study Completion

June 30, 2021

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)