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Completed

NCT Number: NCT02528227

NICU Parent Education Program

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.

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Key information

Conditions

Language Development Female Urogenital Diseases and Pregnancy Complications Neurodevelopmental Outcomes Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Infant Urogenital Diseases

Age range

23 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women and Infants' Hospital

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Know Your Baby Language Curriculum

Other

Early language activities that parents can do with their infants

Reading Aloud Language Curriculum

Other

Early language activity that parents can do with their infants

Sing A Long Language Curriculum

Other

Early language activity that parents can do with their infants

Mimicking First Sounds Language Curriculum

Other

Early language activity that parents can do with their infants

Language Games and Narrating Your Day Language Curriculum

Other

Early language activity that parents can do with their infants

Feeding Safety

Other

Part of Health and Safety Curriculum

Car Seat Safety

Other

Part of Health and Safety Curriculum

Bath Safety

Other

Part of Health and Safety Curriculum

Back to Sleep/SIDS prevention

Other

Part of Health and Safety Curriculum

Taking a Temperature and Signs of Infection

Other

Part of Health and Safety Curriculum

Infection Control Measures and Vaccine Information

Other

Part of Health and Safety Curriculum

Primary outcomes

  1. Bayley III cognitive composite score

    Time frame: 24 months

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

  2. Bayley III language composite score

    Time frame: 24 months

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

  3. Bayley III Expressive Language Score

    Time frame: 24 months

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

  4. Bayley III Receptive Language Score

    Time frame: 24 months

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

  5. Bayley III Motor Composite score

    Time frame: 24 months

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

Secondary outcomes

  1. Infant vocalizations Count

    Time frame: 32 weeks post menstrual age

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

  2. Infant vocalizations Count

    Time frame: 34 weeks post menstrual age

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

  3. Infant vocalizations Count

    Time frame: 36 weeks post menstrual age

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

  4. Conversational turns Count

    Time frame: 32 weeks post menstrual age

    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).

  5. Conversational turns Count

    Time frame: 34 weeks post menstrual age

    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).

  6. Conversational turns Count

    Time frame: 36 weeks post menstrual age

    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).

  7. Adult word count Count

    Time frame: 32 weeks post menstrual age

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

  8. Adult word count

    Time frame: 34 weeks post menstrual age

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

  9. Adult word count

    Time frame: 36 weeks post menstrual age

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

  10. Bayley III cognitive composite score

    Time frame: 12 month

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

  11. Bayley III motor composite score

    Time frame: 12 month

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

  12. Bayley III expressive language score

    Time frame: 12 month (mean 10, standard deviation 3)

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

  13. Bayley III receptive language score

    Time frame: 12 month (mean 10, standard deviation 3)

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

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Acronym: NICU PEP

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2015
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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