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Combined Oral Motor Stimulation and Language on Preterm Infant Feeding

Women and Infants Hospital of Rhode Island logo

Women and Infants Hospital of Rhode Island

Status

Not yet enrolling

Conditions

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

Treatments

Behavioral: Oromotor stimulation
Behavioral: Reading curriculum
Behavioral: LENA recording
Behavioral: LENA linguistic feedback
Behavioral: No oromotor stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05861531
2015266

Details and patient eligibility

About

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.

Full 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.

Enrollment

124 estimated patients

Sex

All

Ages

23 to 30 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 23-30 weeks
  • English and Spanish speaking

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

124 participants in 3 patient groups

Oral motor stimulation with language
Experimental group
Description:
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
Treatment:
Behavioral: LENA linguistic feedback
Behavioral: LENA recording
Behavioral: Reading curriculum
Behavioral: Oromotor stimulation
Oral motor stimulation
Active Comparator group
Description:
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
Treatment:
Behavioral: No oromotor stimulation
Behavioral: LENA linguistic feedback
Behavioral: LENA recording
Behavioral: Reading curriculum
Standard Care
No Intervention group
Description:
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

Trial contacts and locations

0

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Central trial contact

Julia Mayne, MD

Data sourced from clinicaltrials.gov

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