Improving oral feeding in premature infants using a specific intervention
Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial
This study is testing if a new feeding approach can help premature babies learn to eat on their own and breastfeed better before they leave the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 29 Weeks to 30 Weeks |
| Sex | All |
| Sponsor | Fundació Sant Joan de Déu Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT06395298 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the Premature Oral Motor Intervention (PIOMI) combined with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) in facilitating oral feeding in premature infants. The study will assess whether this combined approach allows for the safe withdrawal of external feeding devices while maintaining adequate nutritional status and improving breastfeeding rates at hospital discharge. The trial will take place in a neonatal intensive care unit at a tertiary hospital, focusing on infants born between 29-30 weeks gestational age who are currently reliant on external feeding devices due to feeding difficulties.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates born at the Sant Joan de Déu Hospital with a gestational age of 29-30 weeks who are clinically stable and require external feeding support.
Not a fit: Patients who are intubated, receiving exclusive parenteral nutrition, or have significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the ability of premature infants to feed orally, potentially reducing hospital stays and improving breastfeeding outcomes.
How similar studies have performed: Previous studies have shown promising results with the PIOMI approach, indicating a high success rate in initiating oral feeding in preterm infants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Neonates born at the Sant Joan de Déu Hospital with a gestational age between 29-30 weeks carrying an external feeding device due to the difficulty of oral feeding and that the medical team in charge considers clinically stable. Exclusion Criteria: * Endotracheal intubation or high-flow ventilatory support. * Exclusive parenteral nutrition. * Hyporeactive due to the use of sedative drugs. * Condition of prematurity associated with other pathologies (syndromes, acquired brain damage, gastrointestinal malformations, airway and craniofacial malformations).
Where this trial is running
Barcelona, Catalonia
- Raquel García Ezquerra — Barcelona, Catalonia, Spain (Recruiting)
Study contacts
- Principal investigator: Raquel García Ezquerra — Sant Joan de Déu Hospital
- Study coordinator: Raquel García Equerra
- Email: raquel.garciae@sjd.es
- Phone: 639423251
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.