Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU

Hospital Civil de Guadalajara

Status: Enrolling

Conditions: Premature Infant; Sucking Behavior

Treatments: Behavioral: Physiotherapist-led Oral Stimulation; Behavioral: Parental Oral Stimulation Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT07060573

CEI 149/25

Details and patient eligibility

About

This randomized clinical trial aims to evaluate the effectiveness of an oral stimulation program to improve sucking in preterm neonates hospitalized in the NICU. The study compares two groups: one receiving the intervention from a physiotherapist and the other from trained parents. The stimulation program includes 4 extraoral and 4 intraoral exercises applied once daily for 14 consecutive days. The primary outcome is improvement in the POFRAS score. Secondary outcomes include the time to exclusive oral feeding, nasogastric tube withdrawal, weight at discharge, hospital stay duration, and parental adherence. This study addresses the potential role of parent participation in neonatal rehabilitation in public hospitals with limited human resources.

Full description

This single-blind, randomized clinical trial aims to compare the effectiveness of oral rehabilitation performed by trained parents versus physiotherapists to improve sucking in preterm neonates hospitalized in the NICU at the Hospital Civil de Guadalajara "Fray Antonio Alcalde," during the period July-October 2025.

Eligible neonates will be randomized into two groups:

Group A (Control): Intervention performed daily by a trained physiotherapist.

Group B (Experimental): Intervention performed daily by the parents after structured training and supervised implementation.

The oral stimulation program consists of 4 extraoral and 4 intraoral exercises designed to promote the development of sucking, swallowing, and breathing coordination. Each session lasts approximately 15 minutes and will be applied once daily for 14 consecutive days or until full oral feeding is achieved.

The primary outcome will be improvement in oral feeding readiness, assessed using the validated Spanish version of the POFRAS (Preterm Oral Feeding Readiness Assessment Scale). Secondary outcomes include: achievement of exclusive oral feeding, time to withdrawal of nasogastric tube, weight gain, hospital length of stay, and parent adherence to the protocol.

Randomization will use permuted blocks, and the outcome assessor will be blinded to group assignment. This study explores the feasibility and impact of parent-administered interventions in a public hospital setting with limited specialized personnel.

Enrollment: 32 estimated patients

Sex: All

Ages: 34 to 36 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neonates with corrected gestational age of 34 to 36 weeks
• Clinically stable to receive oral stimulation
• Informed consent obtained from parents or legal guardians

Exclusion criteria

• Orofacial congenital malformations
• Severe neuromuscular disease
• Conditions contraindicating oral feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Parental Oral Stimulation Intervention

Experimental group

Description:

Parents are trained to perform a standardized oral stimulation protocol (4 extraoral and 4 intraoral exercises) once daily for 14 days.

Treatment:

Behavioral: Parental Oral Stimulation Protocol

Physiotherapist-led Oral Stimulation

Active Comparator group

Description:

A licensed physiotherapist performs the same standardized oral stimulation protocol once daily for 14 days

Treatment:

Behavioral: Physiotherapist-led Oral Stimulation