FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 
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  
Status 
Not Applicable 
 
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

  1. Early Feeding Skills Assessment Tool
  2. Non-Nutritive Sucking Score
  3. 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

 
Close