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

Recruiting now · Not applicable

Conditions studied: Premature Infant, Sucking Behavior

In brief

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.

Key facts

Study ID

NCT07060573

Run by

Hospital Civil de Guadalajara

People needed

32

Starts

2025-07-18

Expected to finish

2027-02-01

Last updated by the study team

2026-02-19

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• Orofacial congenital malformations
• Severe neuromuscular disease
• Conditions contraindicating oral feeding

Where it is running

• Antiguo Hospital Civil Guadalajara Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico (enrolling)

Full record on ClinicalTrials.gov

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