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

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

Inclusion Criteria3

  • Neonates with corrected gestational age of 34 to 36 weeks
  • Clinically stable to receive oral stimulation
  • Informed consent obtained from parents or legal guardians

Exclusion Criteria3

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

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

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.


Locations(1)

Antiguo Hospital Civil Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

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NCT07060573


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