Clinical trial NCT03688386: A Language Intervention Study of Preterm Infants
Official title: Bridging Connections: A Language Intervention Study of Preterm Infants in the NICU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Language Development
Language Delay
Mother-Infant Interaction
Maternal Behavior
Keywords: Language intervention
Preterm reading
Heart rate variability
Mother-infant interaction
NICU Network Neurobehavioral Scale
LENA
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 67
Sex: ALL
Minimum age (years): 23
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization of mother infant pairs to a language curriculum with reading (intervention) or an infant bonding curriculum (control)
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial to study a reading intervention in the NICU among preterm infants using LENA (Language Environment Analysis) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient language environment and language outcomes for preterm infants.

Detailed description: This project aims to examine how an educational reading intervention in the NICU can impact preterm infant language development and examine the impact of reading on mother-infant autonomic systems. Investigators plan to determine the effects of parent reading in addition to standard caretaking and holding on preterm infants, between 23 to 31 weeks gestation hospitalized in the Women \& Infants NICU, on adult word count, infant vocalizations, conversational turns through audio recording obtained over 3 separate days when the infant is corrected to 32, 34 and 36 weeks. Investigators aim to determine the effect of parent reading on maternal and infant heart rate variability before, during, and after the shared reading intervention through video and a single channel electrocardiographic recording over the same 3 separate days as the LENA recording. Additionally, investigators aim to determine the effect of parent reading on maternal stress and perceived well-being in the NICU through a validated questionnaire and to determine parent satisfaction of a NICU reading intervention through a parent questionnaire completed prior to infant discharge and at the 12 month follow up visit. Secondary outcomes include determining the effect of parent reading on infant DNA methylation of the several genes through two saliva samples collected from the infant prior to study and post study enrollment and examine its relationship with infant stress and self-regulation based on a neurobehavioral exam performed at 36 weeks corrected age. Final outcomes include examination of the long-term effect of inpatient shared reading education on infant receptive and expressive language development at 12 and 24 months. Investigators hope this research will contribute to the growing research supporting early language development in preterm infants and its impact on maternal-infant well-being.

Eligibility criteria: Inclusion Criteria:

* 21-31 week infants, medically stable infants, English speaking mothers over 18 years old

Exclusion Criteria:

* Intubated or medically unstable, major congenital anomalies, non English speaking

Primary outcomes:
measure: LENA Counts
timeFrame: Change from 32 week language counts to 36 week language counts
Secondary outcomes:
measure: Neonatal Intensive Care Unit Network Neurobehavioral Scale profile
timeFrame: 36 weeks
measure: Bayley Scales of Infant and Toddler Development, Third Edition
timeFrame: 12 months and 24 months
measure: Maternal Well-Being
timeFrame: 36 weeks
measure: Perception of reading and infant bonding
timeFrame: 36 weeks and 12 months
Other outcomes:
measure: DNA methylation
timeFrame: Enrollment and 36 weeks
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital of Rhode Island
name: Betty Vohr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feldman R, Magori-Cohen R, Galili G, Singer M, Louzoun Y. Mother and infant coordinate heart rhythms through episodes of interaction synchrony. Infant Behav Dev. 2011 Dec;34(4):569-77. doi: 10.1016/j.infbeh.2011.06.008. Epub 2011 Jul 20.
citation: Lester BM, Marsit CJ, Giarraputo J, Hawes K, LaGasse LL, Padbury JF. Neurobehavior related to epigenetic differences in preterm infants. Epigenomics. 2015 Oct;7(7):1123-36. doi: 10.2217/epi.15.63. Epub 2015 Nov 20.
citation: Lariviere J, Rennick JE. Parent picture-book reading to infants in the neonatal intensive care unit as an intervention supporting parent-infant interaction and later book reading. J Dev Behav Pediatr. 2011 Feb-Mar;32(2):146-52. doi: 10.1097/DBP.0b013e318203e3a1.
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.