Clinical trial NCT02528227: NICU Parent Education Program
Official title: NICU Parent Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Language Development
Premature Infant
Neurodevelopmental Outcomes
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 95
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bayley III cognitive composite score
timeFrame: 24 months
measure: Bayley III language composite score
timeFrame: 24 months
measure: Bayley III Expressive Language Score
timeFrame: 24 months
measure: Bayley III Receptive Language Score
timeFrame: 24 months
measure: Bayley III Motor Composite score
timeFrame: 24 months
Secondary outcomes:
measure: Infant vocalizations Count
timeFrame: 32 weeks post menstrual age
measure: Infant vocalizations Count
timeFrame: 34 weeks post menstrual age
measure: Infant vocalizations Count
timeFrame: 36 weeks post menstrual age
measure: Conversational turns Count
timeFrame: 32 weeks post menstrual age
measure: Conversational turns Count
timeFrame: 34 weeks post menstrual age
measure: Conversational turns Count
timeFrame: 36 weeks post menstrual age
measure: Adult word count Count
timeFrame: 32 weeks post menstrual age
measure: Adult word count
timeFrame: 34 weeks post menstrual age
measure: Adult word count
timeFrame: 36 weeks post menstrual age
measure: Bayley III cognitive composite score
timeFrame: 12 month
measure: Bayley III motor composite score
timeFrame: 12 month
measure: Bayley III expressive language score
timeFrame: 12 month (mean 10, standard deviation 3)
measure: Bayley III receptive language score
timeFrame: 12 month (mean 10, standard deviation 3)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants' Hospital
state: Rhode Island
Study officials:
affiliation: Women and Infants' Hospital Providence RI
name: Elisabeth C McGowan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.