NICU PEP: NICU Parent Education Program

Sponsor

Women and Infants Hospital of Rhode Island (Other)

Overall Status

Completed

CT.gov ID

NCT02528227

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Language Development Premature Infant Neurodevelopmental Outcomes	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	N/A

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

NICU Parent Education Program

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

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

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