Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parental Oral Stimulation Intervention | Experimental | Parents 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 Comparator | A licensed physiotherapist performs the same standardized oral stimulation protocol once daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parental Oral Stimulation Protocol | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Exclusive Oral Feeding | Number of days required for the neonate to transition from tube feeding to exclusive oral feeding without need for nasogastric support. | From baseline to achievement of full oral feeding (up to 14 days) |
| Weight at Hospital Discharge |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nelsi Alejandra Gonzalez Gonzalez, subspecialty | Contact | +5213312567344 | ngonzalez@hcg.gob.mx | |
| Jose Armando Labra Zepeda, Fellow | Contact | +5213313249586 | drjosearmandolz@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antiguo Hospital Civil Guadalajara Fray Antonio Alcalde | Recruiting | Guadalajara | Jalisco | 44280 | Mexico |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D013391 | Sucking Behavior |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Physiotherapist-led Oral Stimulation | Behavioral | 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. |
|
Body weight in grams recorded at the time of NICU discharge |
| Baseline and Day 14 post-intervention |
| Length of Hospital Stay | Total number of days the neonate remains hospitalized in the neonatal intensive care unit (NICU) until medically cleared for discharge. | From birth until hospital discharge, assessed up to 60 days |
| Parental Satisfaction | Level of parental satisfaction with the intervention protocol, assessed using a 5-point Likert scale (1 = very dissatisfied; 5 = very satisfied). | At Day 14 or end of intervention |
| D000091642 | Urogenital Diseases |
| D001519 | Behavior |