NICU Parent Education Program (NICU PEP)

Women and Infants Hospital of Rhode Island

Status: Completed

Conditions: Neurodevelopmental Outcomes; Premature Infant; Language Development

Treatments: Other: Taking a Temperature and Signs of Infection; Other: Back to Sleep/SIDS prevention; Other: Infection Control Measures and Vaccine Information; Other: Mimicking First Sounds Language Curriculum; Other: Know Your Baby Language Curriculum; Other: Feeding Safety; Other: Language Games and Narrating Your Day Language Curriculum; Other: Car Seat Safety; Other: Bath Safety; Other: Reading Aloud Language Curriculum; Other: Sing A Long Language Curriculum

Study type: Interventional

Funder types: Other

Identifiers

NCT02528227

12-0074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 23 to 32 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups, including a placebo group

Language Curriculum

Experimental group

Description:

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).

Treatment:

Other: Know Your Baby Language Curriculum

Other: Mimicking First Sounds Language Curriculum

Other: Sing A Long Language Curriculum

Other: Reading Aloud Language Curriculum

Other: Language Games and Narrating Your Day Language Curriculum

Health and Safety Curriculum

Placebo Comparator group

Description:

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.

Treatment:

Other: Feeding Safety

Other: Infection Control Measures and Vaccine Information

Other: Back to Sleep/SIDS prevention

Other: Taking a Temperature and Signs of Infection

Other: Car Seat Safety

Other: Bath Safety