NCT Number: NCT07060573
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.
Interested in participating?
Request Info34 week–36 week
All sexes
Interventional
Not applicable
Guadalajara, Jalisco, 44280, Mexico
Location status: Recruiting
Armando Tonatiuh Avila Garcia
SUB_INVESTIGATOR
Hiliana Jocelyn Mejía Romo
SUB_INVESTIGATOR
José Armando Labra Zepeda
SUB_INVESTIGATOR
José Armando Labra Zepeda, fellow
CONTACT
Nelsi Alejandra Gonzalez Gonzalez
PRINCIPAL_INVESTIGATOR
Nelsi Alejandra González González, subspecialty
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: Baseline and Day 14 post-intervention
Body weight in grams recorded at the time of NICU discharge
Time frame: 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.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Jose Armando Labra Zepeda, Fellow
CONTACT
Nelsi Alejandra Gonzalez Gonzalez, subspecialty
CONTACT
Hospital Civil de Guadalajara
Other
Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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