Combined Oral Motor Stimulation and Language on Preterm Infant Feeding

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

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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