Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU
NCT ID: NCT07060573
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
32 participants
INTERVENTIONAL
2025-07-18
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Physiotherapist-led Oral Stimulation
A licensed physiotherapist performs the same standardized oral stimulation protocol once daily for 14 days
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Clinically stable to receive oral stimulation
* Informed consent obtained from parents or legal guardians
Exclusion Criteria
* Severe neuromuscular disease
* Conditions contraindicating oral feeding
34 Weeks
36 Weeks
ALL
No
Sponsors
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Hospital Civil de Guadalajara
OTHER
Responsible Party
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Nelsi Alejandra Gonzalez Gonzalez
Physical Medicine and Rehabilitation Physician
Locations
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Antiguo Hospital Civil Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CEI 149/25
Identifier Type: -
Identifier Source: org_study_id
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