NICU Parent Education Program (NICU PEP)

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.

Study Overview

• Status: Completed
• Conditions: Premature Infant; Language Development; Neurodevelopmental Outcomes
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Women and Infants' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Language Curriculum; 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; Early language activities that parents can do with their infants; Other: Reading Aloud Language Curriculum; Early language activity that parents can do with their infants; Other: Sing A Long Language Curriculum; Early language activity that parents can do with their infants; Other: Mimicking First Sounds Language Curriculum; Early language activity that parents can do with their infants; Other: Language Games and Narrating Your Day Language Curriculum; Early language activity that parents can do with their infants
Placebo Comparator: Health and Safety Curriculum; 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; Part of Health and Safety Curriculum; Other: Car Seat Safety; Part of Health and Safety Curriculum; Other: Bath Safety; Part of Health and Safety Curriculum; Other: Back to Sleep/SIDS prevention; Part of Health and Safety Curriculum; Other: Taking a Temperature and Signs of Infection; Part of Health and Safety Curriculum; Other: Infection Control Measures and Vaccine Information; Part of Health and Safety Curriculum

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Elisabeth C McGowan, MD, Women and Infants' Hospital Providence RI

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 12-0074