Actively Recruiting
Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU: A Randomized Clinical Trial
Led by Hospital Civil de Guadalajara · Updated on 2026-02-19
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the impact of an oral stimulation program aimed at improving sucking in preterm newborns hospitalized in the neonatal intensive care unit (NICU). This randomized clinical trial compares two groups: one receiving the intervention from trained parents and the other from a licensed physiotherapist. The main goal is to evaluate changes in oral feeding readiness using the POFRAS score. The study also looks at secondary outcomes like time to exclusive oral feeding, removal of nasogastric tubes, weight at discharge, hospital stay length, and parental adherence. The research addresses the role of parent involvement in neonatal care in public hospitals with limited staff. The oral stimulation program includes four extraoral and four intraoral exercises performed once daily for 14 consecutive days or until full oral feeding is reached. Each session lasts about 15 minutes and involves exercises such as perioral massage, stimulating the sucking reflex, and non-nutritive sucking using a pacifier. Parents in the experimental group receive structured training and supervision to carry out the protocol, while the control group receives the same intervention from a physiotherapist. Participants are randomly assigned to either group, and the outcome assessor is blinded to group assignments. During the study, participants undergo daily oral stimulation sessions while researchers monitor feeding readiness with the POFRAS scale from baseline to day 14. Additional assessments include tracking the time to exclusive oral feeding, weight gain at discharge, duration of hospital stay up to 60 days, and parental satisfaction at the end of the intervention. The study runs from July to October 2025 and aims to explore the feasibility and effects of parent-led oral rehabilitation in a clinical setting.
CONDITIONS
Brief Title
Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Orofacial congenital malformations
- Severe neuromuscular disease
- Conditions contraindicating oral feeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants receive daily oral stimulation performed either by trained parents or by a physiotherapist to improve sucking in preterm neonates. Each session lasts approximately 15 minutes and is applied once daily for 14 consecutive days or until full oral feeding is achieved.
Daily sessions for up to 14 days
Trial Site Locations
Total: 1 location
1
Antiguo Hospital Civil Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280
Actively Recruiting
Research Team
N
Nelsi Alejandra Gonzalez Gonzalez, subspecialty
J
Jose Armando Labra Zepeda, Fellow
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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