Parent-delivered oral stimulation to help preterm babies learn to suck

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-blind, randomized trial in a Guadalajara NICU compares two arms: daily oral stimulation performed by a trained physiotherapist versus the same protocol performed by parents after structured training. Each ~15-minute session includes four extraoral and four intraoral exercises delivered once daily for up to 14 consecutive days or until full oral feeding is achieved. The primary outcome is change in POFRAS (Preterm Oral Feeding Readiness Assessment Scale); secondary outcomes include time to exclusive oral feeding, nasogastric tube withdrawal, weight at discharge, length of hospital stay, and parent adherence. Outcome assessors are blinded and randomization uses permuted blocks to balance groups.

Why it matters

Who can join: the full rules

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

Where it's running

• Antiguo Hospital Civil Guadalajara Fray Antonio Alcalde
  Guadalajara, Jalisco, Mexico Recruiting

Study contacts

• Study coordinator: Nelsi Alejandra Gonzalez Gonzalez, subspecialty
• Email: ngonzalez@hcg.gob.mx
• Phone: +5213312567344

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.