NCT05861531

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
51mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jul 2025Jul 2030

First Submitted

Initial submission to the registry

April 24, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
2.1 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

September 17, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

April 24, 2023

Last Update Submit

September 10, 2025

Conditions

Language DelayLanguage DevelopmentFeeding; Difficult, NewbornMother-Infant InteractionMaternal Behavior

Keywords

Neonatal feedingNeonatal languageOromotor stimulationNewborn readingParent infant interactionLENA

Outcome Measures

Primary Outcomes (1)

  • Oral feeding measures

    Days to first oral feeding, days to complete oral feeding, hospital days

    From date of birth to day of NICU hospital discharge

Secondary Outcomes (5)

  • Number of adult, infant, and conversational turn word counts measured by LENA device

    From enrollment and biweekly until 36 weeks corrected

  • Maternal stress

    36 weeks corrected

  • Maternal post traumatic stress disorder

    7, 12 and 24 months

  • Child Behavior

    24 months

  • Bayley Scales of Infant and Toddler Development, Fourth Edition

    12 months and 24 months

Study Arms (3)

Oral motor stimulation with language

EXPERIMENTAL

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. When reaches 33-34 weeks postmenstrual age and medically stable, occupational therapists will conduct 10-15 minute oral motor stimulation prior to a feeding time for 10 total days over a 2 week period 6. 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 stimulationBehavioral: Reading curriculumBehavioral: LENA recordingBehavioral: LENA linguistic feedback

Oral motor stimulation

ACTIVE COMPARATOR

1\. Obtain baseline LENA recording 2. LENA recording every 2 weeks until 36 weeks corrected 3. When reaches 33-34 weeks postmenstrual age and medically stable, occupational therapists will conduct 10-15 minute oral motor stimulation prior to a feeding time for 10 total days over a 2 week period. 4. 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 curriculumBehavioral: LENA recordingBehavioral: LENA linguistic feedbackBehavioral: No oromotor stimulation

Standard Care

NO INTERVENTION

1\. Obtain baseline LENA recording 2. LENA recording every 2 weeks until 36 weeks corrected 3. 6. 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

Interventions

Oromotor stimulationBEHAVIORAL

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.

Oral motor stimulation with language
Reading curriculumBEHAVIORAL

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.

Oral motor stimulationOral motor stimulation with language
LENA recordingBEHAVIORAL

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.

Oral motor stimulationOral motor stimulation with language
LENA linguistic feedbackBEHAVIORAL

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.

Oral motor stimulationOral motor stimulation with language
No oromotor stimulationBEHAVIORAL

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.

Oral motor stimulation

Eligibility Criteria

Age23 Weeks - 30 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • weeks
  • English and Spanish speaking

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women & Infants NICU

Providence, Rhode Island, 02905, United States

RECRUITING

Related Publications (4)

  • 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: 21707601BACKGROUND

  • 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: 23582139BACKGROUND

  • 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: 15481778BACKGROUND

  • 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: 16826190BACKGROUND

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Julia Mayne, MD

CONTACT

4014307445jmayne@wihri.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Statistician will analyze deidentified data and Bayley assessments will be conducted by blinded psychologists.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 17, 2023

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2030

Last Updated

September 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)