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

NCT07060573 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Premature Infant
  • Sucking Behavior

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Hospital Civil de Guadalajara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
34 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07060573 on ClinicalTrials.gov