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How effective is the moulding plate to reduce cleft width in babies born with unilateral cleft lip and palate?

Reducing the burden of care for children with clefts: Evaluating the effectiveness of NAsoalveolar Moulding in complete Unilateral non-syndromic Cleft patients (NAMUC Study) - NAMUC

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047426
Enrollment
274
Registered
2022-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q375- Cleft hard and soft palate with unilateral cleft lip

Interventions

Intervention1: NAsoalveolar Moulding (NAM) Treatment: Duration of intervention: 3 years. Nasoalveolar Moulding treatment is provided for babies soon after birth to reduce the size of the cleft (cleft

Sponsors

Bharath Institute of Higher Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Infants with complete unilateral cleft lip and palate b. No syndromes c. Infants d. Medically fit for treatment e. One parent/guardian a native language speaker f. Signed informed consent

Exclusion criteria

Exclusion criteria: a. Consent not obtained b. Bilateral, incomplete or submucous cleft c. Congenital hearing loss or structural middle ear anomalies

Design outcomes

Primary

MeasureTime frame
Facial Aesthetic ScoreTimepoint: T1 to T7 (baseline to 5 years)—

Secondary

MeasureTime frame
Dentofacial development a. Facial Aesthetics measured according to Asher-McDade index Speech: a. Velopharyngeal insufficiency score (score scale from 0-6 and ? 4 will be considered insufficient) b. Velopharyngeal composite summary score c. Articulation Hearing: a. Pure tone audiometry b. Flat line tympanogram Quality of Life: a. Parent Questionnaire: Parents perception of treatment questionnaire (PHQ-9) and Generalized Anxiety and Depressive Symptoms Scale CBU and CEA Qualitative component- care givers perception of treatment Intangible benefitsTimepoint: 3 years (T6);Dentofacial development a. 5-year old index b. Soft tissue ANB from profile photograph c. Skeletal change (ANB) from lateral cephalography d. Facial Aesthetics measured according to Asher-McDade index e. 3D facial aesthetic assessment using Stereophotogrammetrical images a. Velopharyngeal insufficiency score (score scale from 0-6 and ? 4 will be considered insufficient) b. Velopharyngeal composite summary score c. Articulation d. The Intelligibility in Context Scale questionnaire (ICS) Hearing: a. Pure tone audiometry b. Flat line tympanogram Quality of life: a. Parent Questionnaire: Parents perception of treatment questionnaire (PHQ-9) and Generalized Anxiety and Depressive Symptoms Scale Cost Benefit Analysis and Cost Utility Analysis Care givers perception (qualitative) Intangible benefits of researchTimepoint: 5 years (T7);IV. Postoperative (lip and palate)Timepoint: 6 and 12 months (T3&T5);Post NAM therapy a. Overall treatment duration b. Complications with NAM including breakages c. Number of attendances, including failed and cancelled appointment d. Harms (will be reported by parents during the NAM treatment with weekly forms) e. Parent Questionnaire: Parents perception of treatment questionnaire (PHQ-9) and Generalized Anxiety and Depressive Symptoms Scale f. Cost evaluation form (CBA and CEE) g. Qualitative component (care givers perception) Timepoint: —

Countries

India

Contacts

Public ContactBadri Thiruvenkatachari

Bharath Istitute of Higher Education and Research

badri.t.chari@gmail.com7358483837

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026