Learning to Talk, Learning to Eat: A Randomized Controlled Trial to Improve NICU Oral Feeding and Language Outcomes

Study Overview
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Brief Summary
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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
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This project aims to examine how an intervention involving a 10-day oromotor stimulation in combination with a reading curriculum in the NICU can impact preterm infant oral feeding development and examine the additional impact on language development. Investigators plan to determine the effects of an oromotor stimulation beginning at 33 weeks corrected on preterm infants, born between 22-30 weeks in the Women & Infants NICU, as measured by the days to initiate oral feeding, days to complete oral feeding, hospital duration, and NTrainer Pacifier System measures. Infants randomized to standard care without oromotor stimulation will receive the reading curriculum as well. Secondary outcomes will include LENA (Language Environment Analysis) recordings measuring adult word count, infant vocalizations, conversational turns through audio recording obtained biweekly until 36 weeks corrected. Additionally, investigators aim to determine the effect of an intervention of oromotor stimulation with reading on maternal stress and perceived well-being in the NICU through a validated questionnaire completed prior to infant discharge and at the 1, 3, 7, and 12 month follow up visits. Final outcomes include examination of the long-term effect of inpatient oromotor stimulation and 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 the connection between oral feeding and language development in preterm infants and its impact on maternal-infant well-being.

Official Title
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Learning to Talk, Learning to Eat: A Randomized Controlled Trial of an Oromotor Stimulation Intervention vs no Oromotor Stimulation in Combination With a Reading Curriculum to Improve NICU Oral Feeding and Language Outcomes

Conditions
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Language Delay, Language Development, Feeding; Difficult, Newborn, Mother-Infant Interaction, Maternal Behavior

Intervention / Treatment
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* Behavioral: Oromotor stimulation
* Behavioral: Reading curriculum
* Behavioral: LENA recording
* Behavioral: LENA linguistic feedback
* Behavioral: No oromotor stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 22-30 weeks English and Spanish speaking Exclusion Criteria: Major congenital anomalies Surgical necrotizing enterocolitis Non-English and Non-Spanish speaking

Ages Eligible for Study
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Minimum Age: 22 Weeks
Maximum Age: 30 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oromotor stimulation with reading curriculum<br>1. Obtain baseline LENA recording 2. Review language curriculum and provide LENA linguistic feedback 3. LENA recording every 2 weeks until 36 weeks corrected 4. Review age-appropriate language curriculum and provide LENA linguistic feedback from prior weeks 5. NTrainer Pacifier System prior to oromotor stimulation at approximately 33 weeks corrected 6. The day following pre-oromotor stimulation NTrainer Pacifier System session, will conduct 10-15 minute oromotor stimulation behind curtain prior to a feeding time for 10 total days over a 2 week period 7. NTrianer Pacifier System post oromotor stimulation at approximately 35 weeks corrected 8. Final LENA feedback and PTSD screen Assessments: 1. PSS:NICU at 36 weeks corrected 2. PPQ screen at 7, 12, and 24 months corrected 3. Child Behavior Checklist at 24 months corrected 4. Bayley Scales of Infant and Toddler Development at 12 and 24 months | Behavioral: Oromotor stimulation<br>* 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. This will occur 15-30 minutes before a scheduled tube feeding when the infant is tolerating bolus enteral feeds of 120 ml/kg/day for at least 48 hours. This will occur behind a curtain to ensure blinding of staff and parents. Modifications will be made for infants that remain intubated and only 10 minutes of the stroking of the cheeks, lips, gums, and tongue will occur. Stimulation will cease if episodes of oxygen desaturation and/or apnea/bradycardia occur during the stimulation.<br>Behavioral: Reading curriculum<br>* 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.<br>Behavioral: LENA recording<br>* 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.<br>Behavioral: LENA linguistic feedback<br>* 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.<br>|
| Active Comparator: Standard care with reading curriculum<br>1. Obtain baseline LENA recording 2. Review language curriculum and provide LENA linguistic feedback 3. LENA recording every 2 weeks until 36 weeks corrected 4. Review age-appropriate language curriculum and provide LENA linguistic feedback from prior weeks 5. NTrainer Pacifier System prior to oromotor stimulation at approximately 33 weeks corrected 6. The day following pre no oromotor stimulation NTrainer Pacifier System session, will have no oromotor stimulation occur behind curtain for 10-15 minutes prior to a feeding time for 10 total days over a 2 week period 7. NTrainer Pacifier System post no oromotor stimulation at approximately 35 weeks corrected 8. Final LENA feedback and PTSD screen Assessments: 1. PSS:NICU at 36 weeks corrected 2. PPQ screen at 7, 12, and 24 months corrected 3. Child Behavior Checklist at 24 months corrected 4. Bayley Scales of Infant and Toddler Development at 12 and 24 months | Behavioral: Reading curriculum<br>* 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.<br>Behavioral: LENA recording<br>* 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.<br>Behavioral: LENA linguistic feedback<br>* 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.<br>Behavioral: No oromotor stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to oral feeding and non nutritive suck pattterns before and after oromotor stimulation | Days to initiate first oral feed, days to full oral feed, non nutritive suck pattern by NTrainer prior to and after oromotor stimulation or no oromotor stimulation | 33 weeks to 35 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adult, infant, and conversational turn word counts measured by LENA device | Adult word counts, conversational turns, and infant vocalizations from each recording | From enrollment and biweekly until 36 weeks corrected | 
| Maternal stress | Using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) to understand the parents' perceptions of stress within the NICU using 46 questions on a Likert scale with a 5 as extremely stressful and 1 as not stressful at all. Not applicable is also an option as well. | 36 weeks corrected | 
| Maternal post traumatic stress disorder | Perinatal posttraumatic stress disorder (PTSD) Questionnaire to measure maternal PTSD. PTSD symptoms of subjects will be measured with the modified PPQ, which consists of 14 items that measure three dimensions: unwanted intrusions or re-experiencing of delivery, avoidance or emotional numbing and hyperarousal. In the modified PPQ, each PPQ item is rated on five-point Likert scale (with a score of 0 indicating not sick to 4 indicating very sick). mothers with modified PPQ scores⩾19 and <19 as having and not having PTSD, respectively. | 7, 12 and 24 months | 
| Child Behavior | Using Child Behavior Checklist to measure child behavioral and emotional problems in childhood | 24 months | 
| Bayley Scales of Infant and Toddler Development, Fourth Edition | Individual assessment used to assess development of infants between 1 to 42 months of age. Domains are as follows: cognitive, language, motor, social-emotional, and adaptive behavior. Scores can be used to assess infants progress over time. Mean scores of 100 with 1 standard deviation below the mean indicating mild delay and 2 standard deivations below the mean indicating moderate to severe delay. | 12 months and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal feeding, Neonatal language, Oromotor stimulation, Newborn reading, Parent infant interaction, LENA