A Language Intervention Study of Preterm Infants

Bridging Connections: A Language Intervention Study of Preterm Infants in the NICU

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.

Study Overview

• Status: Unknown
• Conditions: Maternal Behavior; Language Development; Mother-Infant Interaction; Language Delay
• Intervention / Treatment: Behavioral: Reading intervention; Behavioral: Infant bonding; Behavioral: LENA recording; Behavioral: LENA linguistic feedback; Behavioral: LENA summary

Detailed Description

This project aims to examine how an educational reading intervention in the NICU can impact preterm infant language development and examine the impact of reading on mother-infant autonomic systems. Investigators plan to determine the effects of parent reading in addition to standard caretaking and holding on preterm infants, between 23 to 31 weeks gestation hospitalized in the Women & Infants NICU, on adult word count, infant vocalizations, conversational turns through audio recording obtained over 3 separate days when the infant is corrected to 32, 34 and 36 weeks. Investigators aim to determine the effect of parent reading on maternal and infant heart rate variability before, during, and after the shared reading intervention through video and a single channel electrocardiographic recording over the same 3 separate days as the LENA recording. Additionally, investigators aim to determine the effect of parent reading on maternal stress and perceived well-being in the NICU through a validated questionnaire and to determine parent satisfaction of a NICU reading intervention through a parent questionnaire completed prior to infant discharge and at the 12 month follow up visit. Secondary outcomes include determining the effect of parent reading on infant DNA methylation of the several genes through two saliva samples collected from the infant prior to study and post study enrollment and examine its relationship with infant stress and self-regulation based on a neurobehavioral exam performed at 36 weeks corrected age. Final outcomes include examination of the long-term effect of inpatient shared reading education on infant receptive and expressive language development at 12 and 24 months. Investigators hope this research will contribute to the growing research supporting early language development in preterm infants and its impact on maternal-infant well-being.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Women and Infants Hospital of Rhode Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 21-31 week infants, medically stable infants, English speaking mothers over 18 years old

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Language Intervention; 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 intervention; 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.; Behavioral: Infant bonding; 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.; Behavioral: LENA recording; 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.; Behavioral: LENA linguistic feedback; 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.
Active Comparator: Infant bonding; 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 bonding; 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.; Behavioral: LENA recording; 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.; Behavioral: LENA summary; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Intensive Care Unit Network Neurobehavioral Scale profile	A validated neurologic assessment of infant neurobehavioral, neurologic and stress responses, and regulatory capacities. The following summary scores and their minimum and maximum scores are as follows: habituation (1-9), attention (1-9), handling (0-1), quality of movement (1-3), regulation (1-9), non optimal reflexes (0-12), asymmetric reflexes (0-7), stress/abstinence (0-1), arousal (1-9), hypertonicity (0-5), hypotonicity (0-3), excitability (0-9), lethargy (0-10). Higher scores indicate the summary score, for example a higher hypertonicity score indicates increased muscle tone whereas a higher hypotonicity score indicates decreased muscle tone. Summary scores are compared to normative scores for high risk preterm infants to compare overall neurobehavior.	36 weeks
Bayley Scales of Infant and Toddler Development, Third Edition	Individual assessment used to assess development of infants between 1 to 42 months of age. Domains and their minimum and maximum scores are as follows: adaptive behavioral (40-160), cognitive 55-145), language (47-153), motor (46-154), and social emotional (55-145). Scores can be used to assess infants progress over time.	12 months and 24 months
Maternal Well-Being	Using the Fragile Infant Parent Readiness Evaluation survey to evaluate maternal well-being	36 weeks
Perception of reading and infant bonding	Parent survey regarding her experience in the NICU with reading, curriculum, and future plans to read to her infant	36 weeks and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
DNA methylation	Understand DNA methylation pattern differences of genes of before and after study participation.	Enrollment and 36 weeks

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Betty Vohr, MD, Women and Infants Hospital of Rhode Island

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Actual): March 3, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Heart rate variability; LENA; Mother-infant interaction; NICU Network Neurobehavioral Scale; Language intervention; Preterm reading
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Language Development Disorders
• Other Study ID Numbers: Pending (Pending)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No