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

RecruitingNAAges 34 Weeks - 36 WeeksAllHospital Civil de Guadalajara
NCT07060573 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * Orofacial congenital malformations * Severe neuromuscular disease * Conditions contraindicating oral feeding
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What it tests

  • Parental Oral Stimulation Protocol
  • Physiotherapist-led Oral Stimulation
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Where

1 site
Antiguo Hospital Civil Guadalajara Fray Antonio Alcalde
Guadalajara, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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