Language Delay, Language Development, Maternal Behavior, Mother-Infant Interaction
Conditions
Keywords
Language intervention, Preterm reading, Heart rate variability, Mother-infant interaction, NICU Network Neurobehavioral Scale, LENA
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.
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.
Interventions
BEHAVIORALReading 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.
BEHAVIORALInfant 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.
BEHAVIORALLENA 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.
BEHAVIORALLENA 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.
BEHAVIORALLENA 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.
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomization of mother infant pairs to a language curriculum with reading (intervention) or an infant bonding curriculum (control)
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 31 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LENA Counts | Change from 32 week language counts to 36 week language counts | Adult word counts, conversational turns, and infant vocalizations from each recording |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Intensive Care Unit Network Neurobehavioral Scale profile | 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. |
| Bayley Scales of Infant and Toddler Development, Third Edition | 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. |
| Maternal Well-Being | 36 weeks | Using the Fragile Infant Parent Readiness Evaluation survey to evaluate maternal well-being |
| Perception of reading and infant bonding | 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
| Measure | Time frame | Description |
|---|---|---|
| DNA methylation | Enrollment and 36 weeks | Understand DNA methylation pattern differences of genes of before and after study participation. |
Countries
United States
Outcome results
None listed