Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Change in POFRAS Score from Day 1 to Day 14
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 34 Weeks to 36 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Parental Oral Stimulation Intervention
Parents are trained to perform a standardized oral stimulation protocol (4 extraoral and 4 intraoral exercises) once daily for 14 days.
Intervention: Parental Oral Stimulation Protocol (Behavioral)
Physiotherapist-led Oral Stimulation
A licensed physiotherapist performs the same standardized oral stimulation protocol once daily for 14 days
Intervention: Physiotherapist-led Oral Stimulation (Behavioral)
Outcomes
Primary Outcomes
Change in POFRAS Score from Day 1 to Day 14
Time Frame: 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 Outcomes
- Time to Exclusive Oral Feeding(From baseline to achievement of full oral feeding (up to 14 days))
- Length of Hospital Stay(From birth until hospital discharge, assessed up to 60 days)
- Weight at Hospital Discharge(Baseline and Day 14 post-intervention)
- Parental Satisfaction(At Day 14 or end of intervention)
Investigators
Nelsi Alejandra Gonzalez Gonzalez
Physical Medicine and Rehabilitation Physician
Hospital Civil de Guadalajara