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Combined Oral Motor Stimulation and Language on Preterm Infant Feeding

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: May 1, 2028 to Jul 1, 2028
    • Study completion date: May 1, 2030 to Jul 1, 2030
    • Start date changed from estimate of May 1, 2025 to Jul 1, 2025
  2. Primary completion date: Jun 1, 2026 to May 1, 2028v2 Show 7 more changesShow less
    • Start date: Jun 1, 2023 to May 1, 2025
    • Primary endpoint revised
    • Study completion date: Jun 1, 2028 to May 1, 2030
    • Eligibility criteria revised
    • Study description shortened, about 89 words
    • Study title shortened, about 8 words
    • Study arms: 2 to 3
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05861531
Lead Sponsor Women and Infants Hospital of Rhode Island
Conditions
(from sponsor)		 Language Delay, Language Development, Feeding; Difficult, Newborn, Mother-Infant Interaction, Maternal Behavior
Related terms Language Development Disorders
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov