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Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.

NCT07219901 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-10-22

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if teaching speech skills to infants with cleft palates, prior to palate repair, will help them to develop speech and language skills. It will also learn about whether the skills are linked to fewer speech sound difficulties when they start school. The main questions it aims to answer are:

Do standard, early intervention techniques to promote language development, that are used in children who are late talkers, work in infants with cleft palates? Will infants with cleft palates increase the number of sounds they use after targeted intervention? Can infants attempt to make stop sounds, like b and p, after targeted intervention? Can infants with cleft palate learn new words more quickly when they are used with gestures?

Participants will:

Participate in a baseline evaluation of speech and language skills, either in person, or via Telehealth.

Attend the clinic for twice-weekly visits, for six weeks, to learn techniques to help their infants develop their speech and language skills, in a group setting with other families of infants with cleft palate.

Participate in a final evaluation of speech and language skills, either in person, or via Telehealth.

Conditions

  • Cleft Lip and Cleft Palate
  • Cleft Lip Palate
  • Cleft Lip and/or Palate
  • Cleft Palate
  • Cleft Palate Children
  • Cleft Palates
  • Cleft Palate Repair

Interventions

BEHAVIORAL

Early intervention for language, articulation and palatal function skills

This intervention will use the principles of focused stimulation, and enhanced milieu teaching, to coach families in the following speech and language development strategies: attempting oral plosives, increasing phonetic inventory, mapping words to gesture use, and promoting canonical babbling.

Sponsors & Collaborators

  • Childrens Hospital of the King's Daughters

    collaborator UNKNOWN

  • Old Dominion University

    lead OTHER

Principal Investigators

  • Victoria Reynolds, LLB BSc PhD · Old Dominion University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07219901 on ClinicalTrials.gov