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CTRI Number  CTRI/2023/11/060033 [Registered on: 20/11/2023] Trial Registered Prospectively
Last Modified On: 18/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [nutritional delivery and naso alveolar molding]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ease of feeding with a novel nipple design in babies born with unilateral cleft lip and palate defect. 
Scientific Title of Study   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. 
Trial Acronym  RCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Surya Kanta Das 
Designation  Professor and Head 
Affiliation  SCB Dental College 
Address  Department of Orthodontics SCB Dental College Cuttack Odisha
Flat No 2E Kingston Residency Cantonment Road Cuttack Odisha
Cuttack
ORISSA
753007
India 
Phone  9861099237  
Fax    
Email  orthosuryakantadas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Surya Kanta Das 
Designation  Professor and Head 
Affiliation  SCB Dental College 
Address  Department of Orthodontics SCB Dental College Cuttack Odisha
Flat No 2E Kingston Residency Cantonment Road Cuttack Odisha

ORISSA
753007
India 
Phone  9861099237  
Fax    
Email  orthosuryakantadas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Surya Kanta Das 
Designation  Professor and Head 
Affiliation  SCB Dental College 
Address  Department of Orthodontics SCB Dental College Cuttack Odisha
Flat No 2E Kingston Residency Cantonment Road Cuttack Odisha

ORISSA
753007
India 
Phone  9861099237  
Fax    
Email  orthosuryakantadas@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswamy Bhawan Po box no 4911 Ansari Nagar New Delhi 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Surya Kanta Das  SCB DENTAL COLLEGE AND HOSPITAL CUTTACK  Department of orthodontics SCB Dental College Manglabag Cuttack
Cuttack
ORISSA 
9861099237

orthosuryakantadas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee SCBDCH Cuttack  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q375||Cleft hard and soft palate with unilateral cleft lip,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  unilateral cleft Children who received spoon feeding, NAM appliance with lip taping for nasoalveolar molding 
Intervention  Intervention group  unilateral clect Children who received special nipple (NLW) for feeding and lip taping with nasal elevators for nasoalveolar molding 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  21.00 Day(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  Associated other congenital defects
Associated genetic disorders
Associated systemic diseases
Syndromic children
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment ease of Feeding
Assessment of parents about feeding or swallowing experience of the child 
1st Day
30th day
60th day
150th day 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of the mechanism of action of the feeder system
 
1st day
150th day 
Assessment of the alveolar cleft site  1st day
150th day 
Assessment of nasal septal deviation and lip position  1st day
150th day 
Growth Parameter Assessment  1st day
30th day
60th day
90th day
120th day
150th day 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Rationale   Cleft lip and palate is the most common congenital anomaly with incidence of two children per 1000 new born babies in Asia where feeding is an immediate concern which leads to malnutrition. To combat feeding issues, a novel feeder consisting of a nipple with lateral wings has been prepared to facilitate feeding and help in alveolar molding by keeping the tongue away from the defect.

 

Novelty   This novel feeder matches the anatomy of the palate and bridges the palatal defect. The child can press the nipple against both the separated palatal shelves for expulsion of milk. 

Objectives   To assess the efficacy and ease of care by using this nipple for feeding and alveolar molding of babies born with unilateral cleft lip and palate defects.

Methods   Participants, less than three week old,  will be a randomly allocated to intervention and control group.  The intervention group will be fed with the novel nipple which will act as a pacifier during other times (along with lip taping and nasal elevation). Those in control group will receive spoon feeding along with NAM appliance. Primary parameters like efficacy of feeding; parent’s experience on feeding; changes in the alveolar cleft and nasal anatomy and secondary parameters like weight, length; will be assessed for twenty weeks. 

Expected Outcome   The present feeder will effectively ease the process of feeding, reduce the burden of care on the parents and enhance the growth parameters of unilateral cleft child. This nipple along with lip taping and nasal elevation will achieve naso-alveolar molding as well. 

 
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