Effectiveness of the Fucile Protocol in improving sucking ability and weight gain in premature low birth infants in Devran-Randomized Controlled Trail (RCT)

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