RecruitingNot ApplicableNCT07060573

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

Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU: A Randomized Clinical Trial

Sponsor

Hospital Civil de Guadalajara

Enrollment

32 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Premature Infant Sucking Behavior

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.

Eligibility

Min Age: 34 WeeksMax Age: 36 Weeks

Plain Language Summary

Simplified for easier understanding

This study is testing whether parents can be taught to perform oral stimulation exercises — gentle movements inside the baby's mouth — to help premature infants in the NICU (newborn intensive care unit) develop their sucking ability sooner, allowing them to feed by mouth more quickly. **You may be eligible if...** - Your baby is a premature infant at a corrected gestational age of 34 to 36 weeks - Your baby is clinically stable and medically cleared to receive oral stimulation - You (the parent or legal guardian) have provided written informed consent to participate **You may NOT be eligible if...** - Your baby has orofacial birth defects (such as cleft lip or palate) - Your baby has severe neuromuscular disease - Your baby has a condition that makes oral feeding unsafe or contraindicated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALParental 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.

BEHAVIORALPhysiotherapist-led Oral Stimulation