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Ease of feeding with a novel nipple design in babies born with unilateral cleft lip and palate defect.

Assessment of the efficacy of a novel nipple designfor ease of feeding and naso-alveolar molding in infants with congenital unilateral cleft lip and palate. - RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060033
Enrollment
116
Registered
2023-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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: Intervention group: unilateral clect Children who received special nipple (NLW) for feeding and lip taping with nasal elevators for nasoalveolar molding Control Intervention1: Control G

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Full term birth baby with unilateral cleft lip and palate and healthy parents without similar deformities. Babies reporting with in 3weeks of birth with minimal weight of 3Kg Parental consent to participate in the study

Exclusion criteria

Exclusion criteria: Associated other congenital defects Associated genetic disorders Associated systemic diseases Syndromic children

Design outcomes

Primary

MeasureTime frame
Assessment ease of Feeding Assessment of parents about feeding or swallowing experience of the childTimepoint: 1st Day 30th day 60th day 150th day—

Secondary

MeasureTime frame
Assessment of nasal septal deviation and lip positionTimepoint: 1st day 150th day;Assessment of the alveolar cleft siteTimepoint: 1st day 150th day;Evaluation of the mechanism of action of the feeder system Timepoint: 1st day 150th day;Growth Parameter AssessmentTimepoint: 1st day 30th day 60th day 90th day 120th day 150th day—

Countries

India

Contacts

Public ContactSurya Kanta Das

SCB Dental College

orthosuryakantadas@gmail.com9861099237

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026