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Clinical Trials/NCT02528227
NCT02528227
Completed
Not Applicable

NICU Parent Education Program

Women and Infants Hospital of Rhode Island1 site in 1 country95 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Language Development
Sponsor
Women and Infants Hospital of Rhode Island
Enrollment
95
Locations
1
Primary Endpoint
Bayley III Expressive Language Score
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Women and Infants Hospital of Rhode Island
Responsible Party
Principal Investigator
Principal Investigator

Elisabeth McGowan

Assistant Professor of Pediatrics

Women and Infants Hospital of Rhode Island

Eligibility Criteria

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

Outcomes

Primary Outcomes

Bayley III Expressive Language Score

Time Frame: 24 months

Bayley III Expressive Language (mean 10, standard deviation 3)

Bayley III Receptive Language Score

Time Frame: 24 months

Bayley III Receptive Language (mean 10, standard deviation 3)

Bayley III cognitive composite score

Time Frame: 24 months

Bayley III cognitive score (mean 100, standard deviation 15)

Bayley III language composite score

Time Frame: 24 months

Bayley III Language score (mean 100, standard deviation 15)

Bayley III Motor Composite score

Time Frame: 24 months

Bayley III Motor composite score (mean 100, standard deviation 15)

Secondary Outcomes

  • Bayley III motor composite score(12 month)
  • Adult word count Count(32 weeks post menstrual age)
  • Bayley III receptive language score(12 month (mean 10, standard deviation 3))
  • Infant vocalizations Count(36 weeks post menstrual age)
  • Conversational turns Count(36 weeks post menstrual age)
  • Adult word count(36 weeks post menstrual age)
  • Bayley III cognitive composite score(12 month)
  • Bayley III expressive language score(12 month (mean 10, standard deviation 3))

Study Sites (1)

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