AzTrials
AzTrials

Language DevelopmentNICU PEPNCT02528227

NICU Parent Education Program

A study testing Know Your Baby Language Curriculum, Reading Aloud Language Curriculum and Sing A Long Language Curriculum in people with Language Development and Premature Infant, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 23 to 32 weeks
What is being tested?
Know Your Baby Language Curriculum, Reading Aloud Language Curriculum and Sing A Long Language Curriculum
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
95 participants
Where
1 siteUnited States
Study dates
Jan 2013to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 23 to 32 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Receiving care at Women \& Infants' Hospital NICU,
  • Providence RI gestational age 23 - 32 weeks,
  • RI resident

Who cannot join

  • Unable to understand or speak English,
  • congenital or chromosomal disorder likely to affect cognitive or speech development,
  • parental loss of custody

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Women and Infants' Hospital

    Providence, Rhode Island, 02903

Other trials in United States

About this study

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.

Read the 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.
Being tested
Know Your Baby Language Curriculum, Reading Aloud Language Curriculum, Sing A Long Language Curriculum, Mimicking First Sounds Language Curriculum, Language Games and Narrating Your Day Language Curriculum
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Know Your Baby Language CurriculumOther

    Early language activities that parents can do with their infants

  • Reading Aloud Language CurriculumOther

    Early language activity that parents can do with their infants

  • Sing A Long Language CurriculumOther

    Early language activity that parents can do with their infants

  • Mimicking First Sounds Language CurriculumOther

    Early language activity that parents can do with their infants

  • Language Games and Narrating Your Day Language CurriculumOther

    Early language activity that parents can do with their infants

  • Feeding SafetyOther

    Part of Health and Safety Curriculum

  • Car Seat SafetyOther

    Part of Health and Safety Curriculum

  • Bath SafetyOther

    Part of Health and Safety Curriculum

  • Back to Sleep/SIDS preventionOther

    Part of Health and Safety Curriculum

  • Taking a Temperature and Signs of InfectionOther

    Part of Health and Safety Curriculum

  • Infection Control Measures and Vaccine InformationOther

    Part of Health and Safety Curriculum

Study groups in NCT02528227
Study groupRoleWhat they receive
Language CurriculumExperimentalThe 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).
Receives: 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
Health and Safety CurriculumPlacebo comparatorParents 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bayley III cognitive composite score

    Bayley III cognitive score (mean 100, standard deviation 15)

    Measured: 24 months

  2. Bayley III language composite score

    Bayley III Language score (mean 100, standard deviation 15)

    Measured: 24 months

  3. Bayley III Expressive Language Score

    Bayley III Expressive Language (mean 10, standard deviation 3)

    Measured: 24 months

  4. Bayley III Receptive Language Score

    Bayley III Receptive Language (mean 10, standard deviation 3)

    Measured: 24 months

  5. Bayley III Motor Composite score

    Bayley III Motor composite score (mean 100, standard deviation 15)

    Measured: 24 months

Secondary outcomes (13)

  1. Infant vocalizations Count

    LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period).

    Measured: 32 weeks post menstrual age

  2. Infant vocalizations Count

    LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period).

    Measured: 34 weeks post menstrual age

  3. Infant vocalizations Count

    LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period).

    Measured: 36 weeks post menstrual age

  4. 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).

    Measured: 32 weeks post menstrual age

  5. 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).

    Measured: 34 weeks post menstrual age

  6. 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).

    Measured: 36 weeks post menstrual age

  7. Adult word count Count

    LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period).

    Measured: 32 weeks post menstrual age

  8. Adult word count

    LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period).

    Measured: 34 weeks post menstrual age

  9. Adult word count

    LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period).

    Measured: 36 weeks post menstrual age

  10. Bayley III cognitive composite score

    Bayley III cognitive score (mean 100, standard deviation 15)

    Measured: 12 month

  11. Bayley III motor composite score

    Bayley III motor score (mean 100, standard deviation 15)

    Measured: 12 month

  12. Bayley III expressive language score

    Bayley III expressive language score (mean 100, standard deviation 15)

    Measured: 12 month (mean 10, standard deviation 3)

  13. Bayley III receptive language score

    Bayley III receptive language score (mean 100, standard deviation 15)

    Measured: 12 month (mean 10, standard deviation 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2015 (estimated)
  2. Study startJan 2013
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02528227
Sponsor's protocol ID
12-0074
Acronym
NICU PEP
Status last verified
May 2022
First submitted
5 Aug 2015
Last updated
3 May 2022
Results posted
No
Data monitoring committee
No

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.

    PubMed 22007020

  • 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.

    PubMed 24515512

  • 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.

    PubMed 37717908

Questions about this trial

What is this clinical trial studying?

A study testing Know Your Baby Language Curriculum, Reading Aloud Language Curriculum and Sing A Long Language Curriculum in people with Language Development and Premature Infant, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bayley III cognitive composite score (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02528227, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022; AzTrials last refreshed its copy on 27 Oct 2026.

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