Clinical Trial

Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU

Recruiting
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-07-01; most recent amendment 2026-02-17.
Status change: Not Yet Recruiting → Recruiting 2025-07-24
Trial Details
NCT Number NCT07060573
Lead Sponsor Hospital Civil de Guadalajara
Conditions Premature Infant, Sucking Behavior
Enrollment 32 participants
Start Date 2025-07-18
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-02-19