Clinical trial NCT05861531: Combined Oral Motor Stimulation and Language on Preterm Infant Feeding
Official title: The Combined Association of an Oral Motor Stimulation and Language Intervention on Preterm Infant Feeding
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Language Delay
Language Development
Feeding; Difficult, Newborn
Mother-Infant Interaction
Maternal Behavior
Keywords: Neonatal feeding
Neonatal language
Oromotor stimulation
Newborn reading
Parent infant interaction
LENA
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 124
Sex: ALL
Minimum age (years): 23
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial to study an oromotor stimulation in combination with a reading curriculum in the NICU among preterm infants using oral muscle exercises, Language Environment Analysis (LENA) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient oral feeding and language outcomes for preterm infants.

Detailed description: This project aims to determine the effects of an oral motor stimulation combined with a reading curriculum vs an oral motor stimulation alone vs controls among preterm infants born 23-30 weeks gestation in the NICU. We hypothesize that the infants receiving an oral motor stimulation in conjunction with a reading curriculum will start oral feeding at an earlier age, have fewer days to full oral feeding, and fewer days in the NICU compared to infants receiving an oral motor stimulation and controls. We hypothesize that the infants receiving an oral motor stimulation in conjunction with a reading curriculum will have increased infant vocalizations, increased conversational turns, increased adult word counts, decreased maternal stress, decreased degree of post-traumatic stress post-discharge, improved receptive and expressive language development at 12 and 24 months, and improved parent reported behavioral outcomes at 24 months.

Eligibility criteria: Inclusion Criteria:

* 23-30 weeks
* English and Spanish speaking

Exclusion Criteria:

* Major congenital anomalies
* Surgical necrotizing enterocolitis
* Non-English and Non-Spanish speaking

Primary outcomes:
measure: Oral feeding measures
timeFrame: From date of birth to day of NICU hospital discharge
Secondary outcomes:
measure: Number of adult, infant, and conversational turn word counts measured by LENA device
timeFrame: From enrollment and biweekly until 36 weeks corrected
measure: Maternal stress
timeFrame: 36 weeks corrected
measure: Maternal post traumatic stress disorder
timeFrame: 7, 12 and 24 months
measure: Child Behavior
timeFrame: 24 months
measure: Bayley Scales of Infant and Toddler Development, Fourth Edition
timeFrame: 12 months and 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: Fucile S, Gisel EG, McFarland DH, Lau C. Oral and non-oral sensorimotor interventions enhance oral feeding performance in preterm infants. Dev Med Child Neurol. 2011 Sep;53(9):829-835. doi: 10.1111/j.1469-8749.2011.04023.x. Epub 2011 Jun 27.
citation: Adams-Chapman I, Bann CM, Vaucher YE, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association between feeding difficulties and language delay in preterm infants using Bayley Scales of Infant Development-Third Edition. J Pediatr. 2013 Sep;163(3):680-5.e1-3. doi: 10.1016/j.jpeds.2013.03.006. Epub 2013 Apr 10.
citation: Dudek-Shriber L. Parent stress in the neonatal intensive care unit and the influence of parent and infant characteristics. Am J Occup Ther. 2004 Sep-Oct;58(5):509-20. doi: 10.5014/ajot.58.5.509.
citation: Callahan JL, Borja SE, Hynan MT. Modification of the Perinatal PTSD Questionnaire to enhance clinical utility. J Perinatol. 2006 Sep;26(9):533-9. doi: 10.1038/sj.jp.7211562. Epub 2006 Jul 6.