NICU Parent Education Program

Not Applicable

Completed

• Conditions: Neurodevelopmental Outcomes; Premature Infant; Language Development

• Registration Number: NCT02528227
• Lead Sponsor: Women and Infants Hospital of Rhode Island

Brief Summary

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

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.

1. Determine the effectiveness of a structured language curriculum with parents of preterm infants in the NICU on increasing the amount of early language exposure.

2. Test the the hypothesis that increased early language exposure will result in higher Bayley III language and cognitive scores.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bayley III Expressive Language Score	24 months	Bayley III Expressive Language (mean 10, standard deviation 3)
Bayley III Receptive Language Score	24 months	Bayley III Receptive Language (mean 10, standard deviation 3)
Bayley III cognitive composite score	24 months	Bayley III cognitive score (mean 100, standard deviation 15)
Bayley III language composite score	24 months	Bayley III Language score (mean 100, standard deviation 15)
Bayley III Motor Composite score	24 months	Bayley III Motor composite score (mean 100, standard deviation 15)

Secondary Outcome Measures

Name	Time	Method
Bayley III motor composite score	12 month	Bayley III motor score (mean 100, standard deviation 15)
Adult word count Count	32 weeks post menstrual age	LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period).
Bayley III receptive language score	12 month (mean 10, standard deviation 3)	Bayley III receptive language score (mean 100, standard deviation 15)
Infant vocalizations Count	36 weeks post menstrual age	LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period).
Conversational turns Count	36 weeks post menstrual age	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).
Adult word count	36 weeks post menstrual age	LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period).
Bayley III cognitive composite score	12 month	Bayley III cognitive score (mean 100, standard deviation 15)
Bayley III expressive language score	12 month (mean 10, standard deviation 3)	Bayley III expressive language score (mean 100, standard deviation 15)

Trial Locations

Locations (1)

Women and Infants' Hospital; 🇺🇸 Providence, Rhode Island, United States