Combined Oral Motor Stimulation and Language on Preterm Infant Feeding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oromotor stimulation, Reading curriculum, LENA recording, LENA linguistic feedback.
- Who it may be relevant to
- Registry conditions: Language Delay, Language Development, Feeding; Difficult, Newborn, Mother-Infant Interaction. Basic parameters: 23 Weeks — 30 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Combined Association of an Oral Motor Stimulation and Language Intervention on Preterm Infant Feeding
Overview
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.
Interventions
- Behavioral Oromotor stimulation
This will begin around 33 weeks corrected, the day following the first NTrainer measurements. The oral stimulation program will be modeled after the protocol designed and studied for preterm infants and will be implemented for a goal of 10 consecutive days within a 14 day period. This includes 10 minutes of stroking the cheeks, lips, gums, and tongue, and the final 5 minutes consisting of mid tongue stroking, eliciting a suck with gloved finger, and sucking on a pacifier provided in the NICU. Th - Behavioral Reading curriculum
Written packets with biweekly lessons. The first two lessons include how to begin to read and talk to their baby. The second two lessons include reading or talking about the day using infant directed speech. The final two lessons include continuing to engage with the baby through interactive reading. - Behavioral LENA recording
The LENA device provides 24 hours of language recordings placed inside an infant vest. The recordings are uploaded to a computer which analyzes total adult word counts, infant vocalizations, conversational turns, background noise, and silence. - Behavioral LENA linguistic feedback
LENA recordings of adult word counts, infant vocalizations, and conversational turns will be provided in printed form after each recording with review of each recording and progress over time. - Behavioral No oromotor stimulation
This will begin around 33 weeks corrected, the day following the first NTrainer measurements. The standard care group will not receive any stimulation but will have a study personnel present behind a curtain to ensure blinding of family, staff, and investigators. The study personnel will remain behind a curtain for 10-15 minutes prior to a feed for 10 days over a 14-day period beginning when the infant is tolerated 120 mL/kg/day for at least 48 hours.
Primary outcome measures
- Oral feeding measures [Time frame: From date of birth to day of NICU hospital discharge]
Secondary outcome measures (5)
- Number of adult, infant, and conversational turn word counts measured by LENA device [Time frame: From enrollment and biweekly until 36 weeks corrected]
- Maternal stress [Time frame: 36 weeks corrected]
- Maternal post traumatic stress disorder [Time frame: 7, 12 and 24 months]
- Child Behavior [Time frame: 24 months]
- Bayley Scales of Infant and Toddler Development, Fourth Edition [Time frame: 12 months and 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Women & Infants NICU — Providence
Publications
- 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. PMID 21707601
- 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. PMID 23582139
- 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. PMID 15481778
- 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. PMID 16826190
Identifiers
NCT: NCT05861531 · 2015266