Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2025
CompletedFirst Posted
Study publicly available on registry
July 11, 2025
CompletedStudy Start
First participant enrolled
July 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
February 19, 2026
February 1, 2026
1.5 years
June 24, 2025
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in POFRAS Score from Day 1 to Day 14
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.
Baseline and Day 14 of intervention
Secondary Outcomes (4)
Time to Exclusive Oral Feeding
From baseline to achievement of full oral feeding (up to 14 days)
Weight at Hospital Discharge
Baseline and Day 14 post-intervention
Length of Hospital Stay
From birth until hospital discharge, assessed up to 60 days
Parental Satisfaction
At Day 14 or end of intervention
Study Arms (2)
Parental Oral Stimulation Intervention
EXPERIMENTALParents are trained to perform a standardized oral stimulation protocol (4 extraoral and 4 intraoral exercises) once daily for 14 days.
Physiotherapist-led Oral Stimulation
ACTIVE COMPARATORA licensed physiotherapist performs the same standardized oral stimulation protocol once daily for 14 days
Interventions
This intervention consists of a structured oral stimulation protocol composed of 4 extraoral and 4 intraoral exercises designed to improve oral motor function in preterm neonates. Exercises include perioral massage, stimulation of sucking reflex, and non-nutritive sucking using a pacifier. The protocol is administered once daily for 14 consecutive days. In this study arm, the intervention is performed by parents, previously trained and supervised in the neonatal unit.
This intervention consists of a structured oral stimulation protocol composed of 4 extraoral and 4 intraoral exercises designed to improve oral motor function in preterm neonates. Exercises include perioral massage, stimulation of sucking reflex, and non-nutritive sucking using a pacifier. The protocol is administered once daily for 14 consecutive days. In this study arm, the intervention is performed by a licensed physiotherapist.
Eligibility Criteria
You may qualify if:
- Neonates with corrected gestational age of 34 to 36 weeks
- Clinically stable to receive oral stimulation
- Informed consent obtained from parents or legal guardians
You may not qualify if:
- Orofacial congenital malformations
- Severe neuromuscular disease
- Conditions contraindicating oral feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antiguo Hospital Civil Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physical Medicine and Rehabilitation Physician
Study Record Dates
First Submitted
June 24, 2025
First Posted
July 11, 2025
Study Start
July 18, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
At this time, there is no plan to share individual participant data (IPD) due to institutional data privacy policies and the absence of a secure data-sharing infrastructure. Data will remain confidential and stored locally, in compliance with ethical and regulatory standards.