Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2013-01-31
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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).
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Providence RI gestational age 23 - 32 weeks,
* RI resident
Exclusion Criteria
* congenital or chromosomal disorder likely to affect cognitive or speech development,
* parental loss of custody
23 Weeks
32 Weeks
ALL
No
Sponsors
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Women and Infants Hospital of Rhode Island
OTHER
Responsible Party
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Elisabeth McGowan
Assistant Professor of Pediatrics
Principal Investigators
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Elisabeth C McGowan, MD
Role: PRINCIPAL_INVESTIGATOR
Women and Infants' Hospital Providence RI
Locations
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Women and Infants' Hospital
Providence, Rhode Island, United States
Countries
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References
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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.
McGowan EC, Caskey M, Tucker R, Vohr BR. A Randomized Controlled Trial of a Neonatal Intensive Care Unit Language Intervention for Parents of Preterm Infants and 2-Year Language Outcomes. J Pediatr. 2024 Jan;264:113740. doi: 10.1016/j.jpeds.2023.113740. Epub 2023 Sep 16.
Other Identifiers
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12-0074
Identifier Type: -
Identifier Source: org_study_id
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