Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parental Oral Stimulation Protocol, Physiotherapist-led Oral Stimulation.
- Who it may be relevant to
- Registry conditions: Premature Infant, Sucking Behavior. Basic parameters: 34 Weeks — 36 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU: A Randomized Clinical Trial
Overview
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.
Interventions
- Behavioral Parental Oral Stimulation Protocol
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. - Behavioral Physiotherapist-led Oral Stimulation
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.
Primary outcome measures
- Change in POFRAS Score from Day 1 to Day 14 [Time frame: Baseline and Day 14 of intervention]
Secondary outcome measures (4)
- Time to Exclusive Oral Feeding [Time frame: From baseline to achievement of full oral feeding (up to 14 days)]
- Weight at Hospital Discharge [Time frame: Baseline and Day 14 post-intervention]
- Length of Hospital Stay [Time frame: From birth until hospital discharge, assessed up to 60 days]
- Parental Satisfaction [Time frame: At Day 14 or end of intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- Antiguo Hospital Civil Guadalajara Fray Antonio Alcalde — Guadalajara
Identifiers
NCT: NCT07060573 · CEI 149/25