| CTRI Number |
CTRI/2026/02/103167 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Feeding bottle with palate occluder for babies with cleft palate ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see whether special feeding bottle with a palate cover helps improve feeding and weight gain in babies with cleft palate |
|
Scientific Title of Study
|
Feeding aid for infants with cleft palate |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRADEEP S |
| Designation |
POST GRADUATE STUDENT MD PAEDITRICS |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of paediatrics,
1st floor Room no 132
Saveetha medical college and hospital
saveetha Nagar
Thandalam
Chennai
Chennai
TAMIL NADU
600124
India |
| Phone |
7708116615 |
| Fax |
|
| Email |
k.s.pradeepsrini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LAAL |
| Designation |
ASSOCIATE PROFESSOR MD PAEDIATRICS |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of paediatrics
1ST Floor Room no 132
Saveetha medical college and hospital
saveetha Nagar
Thandalam
Chennai
Chennai
TAMIL NADU
600124
India |
| Phone |
8333826150 |
| Fax |
|
| Email |
vcr.akash@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
PRADEEP S |
| Designation |
POST GRADUATE STUDENT MD PAEDITRICS |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of paediatrics 1st floor room no 132
Saveetha medical college and hospital
saveetha Nagar
Thandalam
Chennai
Chennai
TAMIL NADU
600124
India |
| Phone |
7708116615 |
| Fax |
|
| Email |
k.s.pradeepsrini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
saveetha Nagar
Thandalam
Chennai 600124
Tamil Nadu
India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Pradeep S |
Saveetha medical college and hospital |
Department of paediatrics 1st floor room no 132
saveetha Nagar
Thandalam
Chennai 600124
Tamil Nadu
India
Chennai
TAMIL NADU |
7708116615
k.s.pradeepsrini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q359||Cleft palate, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Feeding aid for Infants with cleft palate |
A specially designed feeding bottle incorporating a soft palate occluder that temporarily separates the oral and nasal cavities during feeding in infants with cleft palate
The device facilitates effective sucking by enabling generation of negative intraoral pressure and reduces nasal regurgitation and aspiration risk and promotes improved feeding efficiency and weight gain
|
| Comparator Agent |
Standard cleft feeding method |
Feeding using a standard commercially available cleft feeding bottle without a palate occluder or conventional cleft feeding method as per institutional practice which used for oral feeding in infants with cleft palate |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
1 Infants aged 0 to 6 months till 1year with diagnosed cleft lip and or cleft palate awaiting surgical repair
2 Difficulty in feeding confirmed by caregiver or clinical observation such as poor intake frequent nasal regurgitation
3 Medically stable and able to attempt oral feeding.
4 Informed parental consent obtained |
|
| ExclusionCriteria |
| Details |
1 Syndromic clefts with associated severe comorbidities such as cardiac anomalies neurological conditions affecting swallowing
2 Infants requiring bottle feeding for other reasons such as non medical reasons
3 Infants with recurrent pneumonia more than 2 hospitalisation
4 Known severe allergy to medical-grade silicone/plastics used in device |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The feeding bottle with occluder will demonstrate reduced feeding time
fewer nasal regurgitation episodes and improved weight gain compared with
conventional methods |
At birth for baseline and then at 2 weeks 4 weeks 8 weeks 12 weeks of age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The intervention will lower risk of aspiration & feeding associated respiratory infections
The device may prove cost effective user friendly & scalable for use in
low resource settings |
At birth for baseline & then at 2 weeks 4 weeks 8 weeks 12 weeks of age |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/02/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This study is a Phase II single blind parallel group randomized controlled trial evaluating a feeding bottle with an integrated cleft palate occluder in infants with cleft palate A total of 60 infants will be randomly allocated to receive either the occluder integrated bottle or standard cleft feeding methods The trial aims to assess early weight gain feeding efficiency and safety including nasal regurgitation and aspiration events Outcomes will be measured longitudinally over the study period and compared between groups The study is designed to generate evidence for a low-cost practical feeding intervention suitable for routine clinical use |