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

Language Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05861531
• Other study ID #: 2015266
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2028

Study information

• Verified date: May 2023
• Source: Women and Infants Hospital of Rhode Island
• Contact: Julia Mayne, MD
• Phone: 4014307445
• Email: jmayne[@]wihri.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Weeks to 30 Weeks

Eligibility

Inclusion Criteria:

• 22-30 weeks

• English and Spanish speaking

Exclusion Criteria:

• Major congenital anomalies

• Surgical necrotizing enterocolitis

• Non-English and Non-Spanish speaking

Related Conditions & MeSH terms

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

Intervention

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. 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Child Behavior	Using Child Behavior Checklist to measure child behavioral and emotional problems in childhood	24 months
Secondary	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