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A Language Intervention Study of Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688386
Recruitment Status : Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Women and Infants Hospital of Rhode Island

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.

Condition or disease Intervention/treatment Phase
Language Development Language Delay Mother-Infant Interaction Maternal Behavior Behavioral: Reading intervention Behavioral: Infant bonding Behavioral: LENA recording Behavioral: LENA linguistic feedback Behavioral: LENA summary Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization of mother infant pairs to a language curriculum with reading (intervention) or an infant bonding curriculum (control)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bridging Connections: A Language Intervention Study of Preterm Infants in the NICU
Actual Study Start Date : December 4, 2018
Actual Primary Completion Date : March 3, 2020
Estimated Study Completion Date : June 30, 2021

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.




Primary Outcome Measures :
  1. LENA Counts [ Time Frame: Change from 32 week language counts to 36 week language counts ]
    Adult word counts, conversational turns, and infant vocalizations from each recording


Secondary Outcome Measures :
  1. Neonatal Intensive Care Unit Network Neurobehavioral Scale profile [ Time Frame: 36 weeks ]
    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.

  2. Bayley Scales of Infant and Toddler Development, Third Edition [ Time Frame: 12 months and 24 months ]
    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.

  3. Maternal Well-Being [ Time Frame: 36 weeks ]
    Using the Fragile Infant Parent Readiness Evaluation survey to evaluate maternal well-being

  4. Perception of reading and infant bonding [ Time Frame: 36 weeks and 12 months ]
    Parent survey regarding her experience in the NICU with reading, curriculum, and future plans to read to her infant


Other Outcome Measures:
  1. DNA methylation [ Time Frame: Enrollment and 36 weeks ]
    Understand DNA methylation pattern differences of genes of before and after study participation.



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 31 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688386


Locations
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United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
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Principal Investigator: Betty Vohr, MD Women and Infants Hospital of Rhode Island
Publications of Results:
Other Publications:
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Responsible Party: Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT03688386    
Other Study ID Numbers: Pending
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Women and Infants Hospital of Rhode Island:
Language intervention
Preterm reading
Heart rate variability
Mother-infant interaction
NICU Network Neurobehavioral Scale
LENA
Additional relevant MeSH terms:
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Language Development Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases