| 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
|
|
|
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
|
|
|
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. |