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

Not Applicable

Recruiting

• Conditions: Sucking Behavior; Premature Infant

• Registration Number: NCT07060573
• Lead Sponsor: Hospital Civil de Guadalajara

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-06-24
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-01
• Study First Posted: 2025-07-11
• Study Start: 2025-07-18
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-28
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in POFRAS Score from Day 1 to Day 14	Baseline and Day 14 of intervention	Change in the total score of the POFRAS scale (0-36 points), which evaluates oral feeding readiness in preterm neonates. A higher score indicates greater readiness for oral feeding.

Secondary Outcome Measures

Name	Time	Method
Time to Exclusive Oral Feeding	From baseline to achievement of full oral feeding (up to 14 days)	Number of days required for the neonate to transition from tube feeding to exclusive oral feeding without need for nasogastric support.
Length of Hospital Stay	From birth until hospital discharge, assessed up to 60 days	Total number of days the neonate remains hospitalized in the neonatal intensive care unit (NICU) until medically cleared for discharge.
Weight at Hospital Discharge	Baseline and Day 14 post-intervention	Body weight in grams recorded at the time of NICU discharge
Parental Satisfaction	At Day 14 or end of intervention	Level of parental satisfaction with the intervention protocol, assessed using a 5-point Likert scale (1 = very dissatisfied; 5 = very satisfied).

Trial Locations

Locations (1)

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico