NICU Parent Education Program

Study Overview
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Brief Summary
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The purpose of this study is to adminster one of two education programs to parents of preterm infants in the NICU to evaluate language and cognitive outcomes of their infants.

Detailed Description
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The long term goal of this research is to determine the language environment necessary in the NICU for very preterm infants to optimize their long-term language and cognitive development. This study will pilot an early language intervention with parents of preterm infants in the NICU the purpose of which is to provide a structured curriculum for the family to guide their language interactions with their infant. The aim is to increase the adult word counts and conversational turns in the NICU and to improve Bayley III language and cognitive scores at 12 months and 24 months corrected age. The hypotheses is that increasing early language exposure in the NICU will result in improved lanugage and cognitive scores. The investigators plan on testing the hypothesis by the following specific aims. Determine the effectiveness of a structured language curriculum with parents of preterm infants in the NICU on increasing the amount of early language exposure. Test the the hypothesis that increased early language exposure will result in higher Bayley III language and cognitive scores.

Official Title
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NICU Parent Education Program

Conditions
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Language Development, Premature Infant, Neurodevelopmental Outcomes

Intervention / Treatment
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* Other: Know Your Baby Language Curriculum
* Other: Reading Aloud Language Curriculum
* Other: Sing A Long Language Curriculum
* Other: Mimicking First Sounds Language Curriculum
* Other: Language Games and Narrating Your Day Language Curriculum
* Other: Feeding Safety
* Other: Car Seat Safety
* Other: Bath Safety
* Other: Back to Sleep/SIDS prevention
* Other: Taking a Temperature and Signs of Infection
* Other: Infection Control Measures and Vaccine Information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving care at Women & Infants' Hospital NICU, Providence RI gestational age 23 - 32 weeks, RI resident Exclusion Criteria: Unable to understand or speak English, congenital or chromosomal disorder likely to affect cognitive or speech development, parental loss of custody

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Language Curriculum<br>The Language Intervention group will receive some of the known methods for early language development. Six lessons will include: Knowing your Baby, Reading Aloud, Sing-A-Long, Mimicking First Sounds, Language Game and Narrating Your Day. Parents will receive feedback every 2 weeks from a Language Environment Analysis digital language processor (LENA). | Other: Know Your Baby Language Curriculum<br>* Early language activities that parents can do with their infants<br>Other: Reading Aloud Language Curriculum<br>* Early language activity that parents can do with their infants<br>Other: Sing A Long Language Curriculum<br>* Early language activity that parents can do with their infants<br>Other: Mimicking First Sounds Language Curriculum<br>* Early language activity that parents can do with their infants<br>Other: Language Games and Narrating Your Day Language Curriculum<br>* Early language activity that parents can do with their infants<br>|
| Placebo Comparator: Health and Safety Curriculum<br>Parents will receive six lessons on important infant safety topics including, feeding safety, care seat safety, bath safety, back to sleep/SIDS prevention, taking a temperature and signs of infection, infection control methods and vaccine information. Parents will receive LENA feedback at discharge from NICU. | Other: Feeding Safety<br>* Part of Health and Safety Curriculum<br>Other: Car Seat Safety<br>* Part of Health and Safety Curriculum<br>Other: Bath Safety<br>* Part of Health and Safety Curriculum<br>Other: Back to Sleep/SIDS prevention<br>* Part of Health and Safety Curriculum<br>Other: Taking a Temperature and Signs of Infection<br>* Part of Health and Safety Curriculum<br>Other: Infection Control Measures and Vaccine Information<br>* Part of Health and Safety Curriculum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bayley III cognitive composite score | Bayley III cognitive score (mean 100, standard deviation 15) | 24 months | 
| Bayley III language composite score | Bayley III Language score (mean 100, standard deviation 15) | 24 months | 
| Bayley III Expressive Language Score | Bayley III Expressive Language (mean 10, standard deviation 3) | 24 months | 
| Bayley III Receptive Language Score | Bayley III Receptive Language (mean 10, standard deviation 3) | 24 months | 
| Bayley III Motor Composite score | Bayley III Motor composite score (mean 100, standard deviation 15) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant vocalizations Count | LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period). | 32 weeks post menstrual age | 
| Infant vocalizations Count | LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period). | 34 weeks post menstrual age | 
| Infant vocalizations Count | LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period). | 36 weeks post menstrual age | 
| Conversational turns Count | LENA recordings of infant-parent conversational turns (softward derived recording of adult-child interactions that estimates the number of reciprocal vocalizations between infant and adult within 5 seconds, and recorded for a 16 hour time period). | 32 weeks post menstrual age | 
| Conversational turns Count | LENA recordings of infant-parent conversational turns (softward derived recording of adult-child interactions that estimates the number of reciprocal vocalizations between infant and adult within 5 seconds, and recorded for a 16 hour time period). | 34 weeks post menstrual age | 
| Conversational turns Count | LENA recordings of infant-parent conversational turns (softward derived recording of adult-child interactions that estimates the number of reciprocal vocalizations between infant and adult within 5 seconds, and recorded for a 16 hour time period). | 36 weeks post menstrual age | 
| Adult word count Count | LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period). | 32 weeks post menstrual age | 
| Adult word count | LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period). | 34 weeks post menstrual age | 
| Adult word count | LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period). | 36 weeks post menstrual age | 
| Bayley III cognitive composite score | Bayley III cognitive score (mean 100, standard deviation 15) | 12 month | 
| Bayley III motor composite score | Bayley III motor score (mean 100, standard deviation 15) | 12 month | 
| Bayley III expressive language score | Bayley III expressive language score (mean 100, standard deviation 15) | 12 month (mean 10, standard deviation 3) | 
| Bayley III receptive language score | Bayley III receptive language score (mean 100, standard deviation 15) | 12 month (mean 10, standard deviation 3) |