NCT02528227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 3, 2022

Status Verified

May 1, 2022

Enrollment Period

8 years

First QC Date

August 5, 2015

Last Update Submit

May 2, 2022

Conditions

Language DevelopmentPremature InfantNeurodevelopmental Outcomes

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (13)

  • Infant vocalizations Count

    32 weeks post menstrual age

  • Infant vocalizations Count

    34 weeks post menstrual age

  • Infant vocalizations Count

    36 weeks post menstrual age

  • Conversational turns Count

    32 weeks post menstrual age

  • Conversational turns Count

    34 weeks post menstrual age

  • +8 more secondary outcomes

Study Arms (2)

Language Curriculum

EXPERIMENTAL

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 CurriculumOther: Reading Aloud Language CurriculumOther: Sing A Long Language CurriculumOther: Mimicking First Sounds Language CurriculumOther: Language Games and Narrating Your Day Language Curriculum

Health and Safety Curriculum

PLACEBO COMPARATOR

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 SafetyOther: Car Seat SafetyOther: Bath SafetyOther: Back to Sleep/SIDS preventionOther: Taking a Temperature and Signs of InfectionOther: Infection Control Measures and Vaccine Information

Interventions

Know Your Baby Language CurriculumOTHER

Early language activities that parents can do with their infants

Language Curriculum
Reading Aloud Language CurriculumOTHER

Early language activity that parents can do with their infants

Language Curriculum
Sing A Long Language CurriculumOTHER

Early language activity that parents can do with their infants

Language Curriculum
Mimicking First Sounds Language CurriculumOTHER

Early language activity that parents can do with their infants

Language Curriculum
Language Games and Narrating Your Day Language CurriculumOTHER

Early language activity that parents can do with their infants

Language Curriculum
Feeding SafetyOTHER

Part of Health and Safety Curriculum

Health and Safety Curriculum
Car Seat SafetyOTHER

Part of Health and Safety Curriculum

Health and Safety Curriculum
Bath SafetyOTHER

Part of Health and Safety Curriculum

Health and Safety Curriculum
Back to Sleep/SIDS preventionOTHER

Part of Health and Safety Curriculum

Health and Safety Curriculum
Taking a Temperature and Signs of InfectionOTHER

Part of Health and Safety Curriculum

Health and Safety Curriculum
Infection Control Measures and Vaccine InformationOTHER

Part of Health and Safety Curriculum

Health and Safety Curriculum

Eligibility Criteria

Age23 Weeks - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women and Infants' Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (3)

  • 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.

    PMID: 22007020RESULT

  • 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.

    PMID: 24515512RESULT

  • 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.

    PMID: 37717908DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Elisabeth C McGowan, MD

    Women and Infants' Hospital Providence RI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 19, 2015

Study Start

January 1, 2013

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 3, 2022

Record last verified: 2022-05

Locations

US(1)