| CTRI Number |
CTRI/2025/06/089658 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Helping Preterm Babies Feed Better and Gain Weight in Dervan |
|
Scientific Title of Study
|
Effectiveness of the Fucile Protocol in improving sucking ability and weight gain in premature low birth infants in Devran-Randomized Controlled Trail (RCT) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mansi Sharad Chile |
| Designation |
Post Graduate Resident |
| Affiliation |
B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, |
| Address |
B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, Paediactrics- Department, Division- Premature Low Birth Infants, Ward No- 21 & 22, Tal- Chiplun, Dist-Ratanagari, 415606 Maharashtra University of Health Sciences, Nashik
Ratnagiri MAHARASHTRA 415606 India |
| Phone |
8779712036 |
| Fax |
|
| Email |
mansischile@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Thaiba Reinai |
| Designation |
HOD |
| Affiliation |
B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, |
| Address |
B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, Paediactrics- Department, Division- Premature Low Birth Infants, Ward No- 21 & 22, Tal- Chiplun, Dist-Ratanagari, 415606 Maharashtra University of Health Sciences, Nashik
Ratnagiri MAHARASHTRA 415606 India |
| Phone |
9582971604 |
| Fax |
|
| Email |
reinaithaiba@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mansi Sharad Chile |
| Designation |
Post Graduate Resident |
| Affiliation |
B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, |
| Address |
B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde, Paediactrics- Department, Division- Premature Low Birth Infants, Ward No- 21 & 22, Tal- Chiplun, Dist-Ratanagari, 415606 Maharashtra University of Health Sciences, Nashik
Ratnagiri MAHARASHTRA 415606 India |
| Phone |
8779712036 |
| Fax |
|
| Email |
mansischile@gmail.com |
|
|
Source of Monetary or Material Support
|
| B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde,Tal- Chiplun, Dist-Ratanagari, 415606 Maharashtra University of Health Sciences, Nashik |
|
|
Primary Sponsor
|
| Name |
Dr Mansi Sharad Chile |
| Address |
B.K.L Walawalkar College of Physiotherapy Kasarwadi, Sawarde,Tal - Chiplun, Dist-Ratanagari, 415606 Maharashtra University of Health Sciences, Nashik |
| Type of Sponsor |
Other [Self] |
|
|
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 Mansi Shrad Chile |
B.K.L Walalkar Hospital, Diagnostic & Research Center |
B.K.L Walawalkar College of Physiotherapy Kasarwadi,Sawarde,Paediatrics Department, Ward No- 21 & 22, Tal- Chiplun, Dist-Ratanagari, 415606 Maharashtra University of Health Sciences, Nashik Ratnagiri MAHARASHTRA |
8779712036
mansischile@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| B.K.L Walawalkar College of Physiotherapy (MUHS) Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F982||Other feeding disorders of infancyand childhood, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FUCILE PROTOCOL |
The oromotor stimulation protocol involves a structured sequence of tactile inputs targeting the cheeks, lips, gums, and tongue to enhance oral motor function in preterm infants. Each component is stimulated using gentle compression, circular motions, and sustained pressure to improve range of motion, strength, and coordination necessary for effective oral feeding.Stimulation includes cheek massage (C-pattern), upper and lower lip mobilization, upper-lower lip curling, and gum stroking to facilitate tongue movement and suck reflex. Additional maneuvers target the internal cheeks, lateral tongue borders, and midblade of the tongue to stimulate swallow and strengthen oral structures. Given to the infants for 10 Days once a day
|
| Comparator Agent |
ROUTINE FEEDING PROTOCOL |
Routine Feeding is given to Infants for 10 days once a day. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
1. Premature infants born between 28 to 34weeks gestational age,
2. Birth weight less than 2500 grams
3. Medically stable with no respiratory support for atleast 48 hrs
4. Full gavage feeds of 150cc/kg/day |
|
| ExclusionCriteria |
| Details |
1. Respiratory distress
2. Chronic medical complication Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Periventricular Leukomalacia, Necrotizing Enterocolitis.
3. Chromosomal anomalies
4. Craniofacial malformation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the impact of the Fucile Protocol on improving sucking ability in premature low-birth-weight infants.
2. To evaluate the effectiveness of the Fucile Protocol in improving weight gain among premature low-birth-weight infants. |
Baseline & 10th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/08/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
NEED OF THE STUDY Low-birth-weight (LBW) infants often struggle with early feeding due to immature oral motor function, poor coordination of sucking, swallowing, and breathing, and reduced endurance, leading to increased complications, and suboptimal weight gain that can impact long-term growth and neurodevelopment.The Fucile Protocol, effectiveness in specific neonatal populations, particularly in Dervan, remains underexplored. This study aims to bridge this gap by evaluating its impact on enhancing Oromotor function, improving weight gain by accelerating feeding readiness. Research Question In premature low-birth-weight infants in Dervan, how effective is the Fucile Protocol compared to standard care in improving sucking ability and weight gain? Hypothesis PRIMARY HYPOTHESIS The Fucile Protocol significantly improves sucking ability and weight gain in premature low-birth-weight infants in Dervan. Null Hypothesis The Fucile Protocol has no significant effect in improving sucking ability and weight gain in premature low-birth-weight infants in Dervan. Objectives 1. To assess the impact of the Fucile Protocol on improving sucking ability in premature low-birth-weight infants. 2. To evaluate the effectiveness of the Fucile Protocol in improving weight gain among premature low-birth-weight infants.
Inclusion Criteria 1. Premature infants born between 28 to 34weeks gestational age, 2. Birth weight less than 2500 grams 3. Medically stable with no respiratory support for atleast 48 hrs 4. Full gavage feeds of 150cc/kg/day Exclusion Criteria • 1. Respiratory distress 2. Chronic medical complication Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Periventricular Leukomalacia, Necrotizing Enterocolitis. 3. Chromosomal anomalies 4. Craniofacial malformation Operational Definition Fucile Protocol :- The Fucile Protocol refers to a specific oromotor intervention developed by Fucile et al., which includes oral and non-nutritive stimulation aimed at improving oral feeding skills in preterm infants. Sucking Ability :- Sucking Ability refers to the infant’s capacity to coordinate and perform the suck-swallow-breathe pattern during feeding. Preterm Low Birth Infant :- Preterm infants are those born before 37 completed weeks of gestation. For this study, only infants born between 28 to 34 weeks will be included. Low birth weight :- It is defined as a birth weight of less than 2500 grams. Variables Independent Variables Fucile Protocol Dependent Variables Sucking Ability Weight gain Outcomes Measures - Early Feeding Skills Assessment Tool
- Non-Nutritive Sucking Score
- Weight Gain Chart
Study Instruments/Data Collection Tools used :- • Gloves • Pacifier • Weighing machine • Weight gain and hospital duration chart
Procedure Intervention used : Fucile protocol ( Experimental Group) & Routine Feeding Protocol ( Control Group) Total treatment time : 10 consecutive days/Duration of treatment for 15 minutes Fucile Protocol The oromotor stimulation protocol involves a structured sequence of tactile inputs targeting the cheeks, lips, gums, and tongue to enhance oral motor function in preterm infants.Each component is stimulated using gentle compression, circular motions, and sustained pressure to improve range of motion, strength, and coordination necessary for effective oral feeding. Stimulation includes cheek massage (C-pattern), upper and lower lip mobilization, upper-lower lip curling, and gum stroking to facilitate tongue movement and suck reflex. Additional maneuvers target the internal cheeks, lateral tongue borders, and midblade of the tongue to stimulate swallow and strengthen oral structures. The procedure concludes with eliciting a non-nutritive suck through gentle stroking of the palate and pacifier placement. Performed once daily, each step has a defined frequency and duration, ranging from 1 to 2 minutes, ensuring a standardized approach to promoting feeding readiness in preterm infants. 
Routine Feeding Protocol Routine feeding protocol is given to the infants |