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

NCT07219901 | Not Yet Recruiting

• 1 other identifier: 2355082-5
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cleft-type speech; hypernasality; palatal function; compensatory speech patterns; obligatory speech patterns; velopharyngeal dysfunction; communication; language; speech

Outcome Measures

Primary Outcomes (1)

• MBCDI (W&G)

  Number of words and concepts, as measured by the MacArthur-Bates Communicative Development Inventory (Words and Gestures)

  From enrollment to the end of treatment at 8 weeks.

Secondary Outcomes (5)

• Plosive attempts

  From enrollment until the end of treatment at 8 weeks.

• Phonemes

  From enrollment to the end of treatment at 8 weeks.

• Canonical babbling: frequency

  From enrollment to the end of treatment at 8 weeks.

• Canonical babbling: shape

  From enrollment to the end of treatment at 8 weeks.

• Words versus gestures

  From study enrollment to end of treatment at 8 weeks.

Other Outcomes (3)

• Caregiver confidence

  From enrollment to end of treatment at 8 weeks.

• Conversational turn-taking: length of conversational utterance

  From enrollment to end of treatment at 8 weeks

• Conversational turn-taking: frequency of conversational utterance

  From enrollment to end of treatment at 8 weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

All participants will be allocated to this arm; they will receive the intervention as detailed elsewhere in this protocol.

Behavioral: Early intervention for language, articulation and palatal function skills

Interventions

Early intervention for language, articulation and palatal function skills BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with unrepaired cleft palate (with or without cleft lip)
• Aged between 6 and 10 months at the time of study commencement

You may not qualify if:

• Medically fragile status that would preclude participation in this community-based study.
• Palatoplasty completed.
• Aged over one year
• Infants with cleft lip only

Sponsors & Collaborators

• Old Dominion University: lead
• Childrens Hospital of the King's Daughters: collaborator

Study Sites (1)

Old Dominion University

Norfolk, Virginia, 23529, United States

Location

MeSH Terms

Conditions

Cleft Lip; Cleft Palate; Communication; Language; Speech

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Behavior; Verbal Behavior

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Victoria Reynolds, LLB BSc PhD

  Old Dominion University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Reynolds, LLB BSc PhD

CONTACT

551-202-1970; m1reynol@odu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 16, 2025
• First Posted: October 22, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)