NICU Parent Education Program

Premature Infant Clinical Trial

— NICU PEP  

Official title:

NICU Parent Education Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528227
• Other study ID #: 12-0074
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2022
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Language Development
• Neurodevelopmental Outcomes
• Premature Infant

Intervention

Other:
• Know Your Baby Language Curriculum
Early language activities that parents can do with their infants
• Reading Aloud Language Curriculum
Early language activity that parents can do with their infants
• Sing A Long Language Curriculum
Early language activity that parents can do with their infants
• Mimicking First Sounds Language Curriculum
Early language activity that parents can do with their infants
• Language Games and Narrating Your Day Language Curriculum
Early language activity that parents can do with their infants
• Feeding Safety
Part of Health and Safety Curriculum
• Car Seat Safety
Part of Health and Safety Curriculum
• Bath Safety
Part of Health and Safety Curriculum
• Back to Sleep/SIDS prevention
Part of Health and Safety Curriculum
• Taking a Temperature and Signs of Infection
Part of Health and Safety Curriculum
• Infection Control Measures and Vaccine Information
Part of Health and Safety Curriculum

Locations

Country	Name	City	State
United States	Women and Infants' Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (2)

Caskey M, Stephens B, Tucker R, Vohr B. Adult talk in the NICU with preterm infants and developmental outcomes. Pediatrics. 2014 Mar;133(3):e578-84. doi: 10.1542/peds.2013-0104. Epub 2014 Feb 10. — View Citation

Caskey M, Stephens B, Tucker R, Vohr B. Importance of parent talk on the development of preterm infant vocalizations. Pediatrics. 2011 Nov;128(5):910-6. doi: 10.1542/peds.2011-0609. Epub 2011 Oct 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bayley III cognitive composite score	Bayley III cognitive score (mean 100, standard deviation 15)	24 months
Primary	Bayley III language composite score	Bayley III Language score (mean 100, standard deviation 15)	24 months
Primary	Bayley III Expressive Language Score	Bayley III Expressive Language (mean 10, standard deviation 3)	24 months
Primary	Bayley III Receptive Language Score	Bayley III Receptive Language (mean 10, standard deviation 3)	24 months
Primary	Bayley III Motor Composite score	Bayley III Motor composite score (mean 100, standard deviation 15)	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Bayley III cognitive composite score	Bayley III cognitive score (mean 100, standard deviation 15)	12 month
Secondary	Bayley III motor composite score	Bayley III motor score (mean 100, standard deviation 15)	12 month
Secondary	Bayley III expressive language score	Bayley III expressive language score (mean 100, standard deviation 15)	12 month (mean 10, standard deviation 3)
Secondary	Bayley III receptive language score	Bayley III receptive language score (mean 100, standard deviation 15)	12 month (mean 10, standard deviation 3)