Parent-delivered oral stimulation to help preterm babies learn to suck
Effects of Oral Stimulation Performed by Parents to Improve Sucking in Neonates Hospitalized in the NICU: A Randomized Clinical Trial
This study tests whether a 14-day program of extraoral and intraoral stimulation, taught to parents, helps preterm infants in the NICU improve sucking compared with stimulation given by a physiotherapist.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 34 Weeks to 36 Weeks |
| Sex | All |
| Sponsor | Hospital Civil de Guadalajara Academic / other |
| Locations | 1 site (Guadalajara, Jalisco) |
| Trial ID | NCT07060573 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Clinically stable preterm neonates with corrected gestational age 34–36 weeks hospitalized in the NICU whose parents provide informed consent and can be trained to perform the protocol.
Not a fit: Infants with orofacial congenital malformations, severe neuromuscular disease, conditions contraindicating oral feeding, or those who cannot tolerate stimulation are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, trained parents could help their preterm infants reach full oral feeding sooner, potentially shortening hospital stays and reducing the need for specialized staff time.
How similar studies have performed: Previous studies indicate structured oral stimulation can accelerate transition to oral feeding in preterm infants, and parent-delivered programs have shown promising but mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guadalajara, Jalisco
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.