Determination of correlation of upper lip tie and breast-feeding difficulty in infants using hop-roc assessment:a cross-sectional study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- The infant’s upper lip was elevated and photographed with a standard ruler using a high-definition camera. Measurements were calibrated with Digimizer software. The superior labial frenum was assessed using the Hopkin–Rochester (HOP-ROC) 3-point scale. Breast-feeding experience was evaluated using the Infant Breast-Feeding Assessment Tool (IBFAT).
Study Overview
Brief Summary
Thirty three infants will be examined in pediatric hospitals in Chennai. Infants weight, age and demographic data will be collected from infant’s medical record. A standardised protocol will be followed to capture images of the superior labial frenulum of the infants. Each infant’s upper lip was elevated and retracted to the level of alveolar sulcus. A standard ruler will be placed into the image frame and multiple pictures of infant’s superior labial frenum (SLF) will be obtained. Digimiser software will be used to calibrate the measurement scale for each photograph. Assessment of the superior labial frenum is done by Hopkin-Rochester [HOP-ROC].
Three point scale including the parameters such as length of frenulum on stretch, length of alveolar edge to gingival attachment length and free - lip to total lip length ratio. Based on the scores obtained according to the parameters, infants will be grouped into three risk categories: Low (0), Medium (1,2), High (3).
Infant Breast- Feeding Assessment Tool (IBFAT) questionnaire will be used to evaluate the breast feeding experience of the mothers of the infants. IBFAT is a validated four item questionnaire describing infant’s breast feeding on scale from 0-12 points, each answer provides a score (0-3) proportional to the infant’s efficacy in breast feeding. Score less than or equal to 8 reveal difficult breast feeding.
Correlation between the risk categories and breast feeding scores will be analysed.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 0.00 Month(s) to 18.00 Month(s) (—)
- Sex
- All
Inclusion Criteria
- •Infants 0 to18 months of age Breast-feeding mothers of infants 0 to 18 months Healthy infant and Breast-feeding mother Parents of the infants who are willing to participate in the study.
Exclusion Criteria
- •Infants admitted to neonatal intensive care unit History of frenectomy Infants with cleft lip and palate Infants diagnosed with craniofacial anomalies.
Outcomes
Primary Outcomes
The infant’s upper lip was elevated and photographed with a standard ruler using a high-definition camera. Measurements were calibrated with Digimizer software. The superior labial frenum was assessed using the Hopkin–Rochester (HOP-ROC) 3-point scale. Breast-feeding experience was evaluated using the Infant Breast-Feeding Assessment Tool (IBFAT).
Time Frame: All assessments will be conducted at a single time point.
Secondary Outcomes
- The infant’s upper lip was elevated & photographed with a standard ruler using a high-definition camera. Measurements were calibrated with Digimizer software. The superior labial frenum was assessed using the Hopkin–Rochester (HOP-ROC) 3-point scale. Breast-feeding experience was evaluated using the Infant Breast-Feeding Assessment Tool (IBFAT).
Investigators
Dr M S Saravana Kumar
Sri Venkateswara Dental College and Hospital