Assessment of fetal swallowing with gray-scale and color Doppler sonography.
Roberto Grassi, Roberto Farina, Irene Floriani...
https://pubmed.ncbi.nlm.nih.gov/16247157Actively Recruiting
Phase Not Applicable
Age: 29Weeks - 30Weeks
All Genders
ID06395298
Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial
Led by Fundació Sant Joan de Déu · Updated on 2024-05-02
35
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
F
Fundació Sant Joan de Déu
Lead Sponsor
S
Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prematurity can affect the development of oral motor skills, making feeding difficult due to an uncoordinated sucking-breathing-swallowing cycle. This trial evaluates whether combining the Premature Oral Motor Intervention (PIOMI) with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) improves feeding outcomes, including earlier removal of external feeding devices, breastfeeding rates at hospital discharge, and swallowing safety. The study also examines the applicability of this standardized protocol in a neonatal intensive care unit setting. Participants are randomly assigned to two groups: one receives the standard NIDCAP care model, and the experimental group receives PIOMI plus NIDCAP care. The PIOMI involves intraoral stimulation through seven activities conducted twice daily for five minutes over ten days. Both groups receive gustatory stimulation with oropharyngeal colostrum and olfactory stimulation using breast milk swabs near the nose twice daily. Families apply the assigned interventions with guidance provided via a quick response code. Throughout the study, researchers monitor feeding progress using tools like the Neonatal Oral-motor Assessment Scale and Early Feeding Skills Assessment. They track time to removal of external feeding devices, volume of intake at discharge, hospitalization length, breastfeeding status after discharge, and weight at discharge and ten days later. The trial runs from 2023 to 2026, with detailed assessments and data analysis to understand the benefits and feasibility of the intervention protocol in preterm infants aged 29 to 30 weeks gestational age.
CONDITIONS
Brief Title
Effects of the Application of PIOMI in the Oral Feeding of Premature
Who Can Participate
Age: 29Weeks - 30Weeks
All Genders
Eligibility Criteria
You may qualify if you...
- Neonates born at the Sant Joan de Déu Hospital with a gestational age between 29 and 30 weeks
- Presence of an external feeding device due to difficulty with oral feeding
- Considered clinically stable by the medical team
You will not qualify if you...
- Use of endotracheal intubation or high-flow ventilatory support
- Exclusive parenteral nutrition
- Hyporeactivity due to sedative drugs
- Prematurity associated with other pathologies such as syndromes, acquired brain damage, gastrointestinal malformations, airway or craniofacial malformations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 10 days
Participants receive either the traditional Newborn Individualized Development Care and Assessment Program (NIDCAP) or the NIDCAP combined with the Premature Oral Motor Intervention (PIOMI). Both groups also receive olfactory stimulation and oropharyngeal colostrum. The intervention is applied twice a day for 5 minutes over 10 consecutive days.
Twice daily interventions by family members; routine nursing care visits in the NICU
Follow-up
Duration - Up to 12 weeks
Participants are monitored for feeding outcomes and health status up to hospital discharge and up to 12 weeks after birth.
Visits as part of routine hospital care and follow-up assessments until hospital discharge and post-discharge up to 12 weeks
Trial Site Locations
Total: 1 location
1
Raquel García Ezquerra
Barcelona, Catalonia, Spain, 08096
Actively Recruiting
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Research Team
R
Raquel García Equerra
V
Vanesa Ejarque Marin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
The effects of premature infant oral motor intervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial.
Hadiseh Ghomi, Fariba Yadegari, Farin Soleimani...
https://pubmed.ncbi.nlm.nih.gov/30851536Oral Motor Intervention Improved the Oral Feeding in Preterm Infants: Evidence Based on a Meta-Analysis With Trial Sequential Analysis.
Xu Tian, Li-Juan Yi, Lei Zhang...
https://pubmed.ncbi.nlm.nih.gov/26252313The effect of feeding experience on clinical outcomes in preterm infants.
R H Pickler, A Best, D Crosson
https://pubmed.ncbi.nlm.nih.gov/18830247Effects of oral stimulation and oral support on non-nutritive sucking and feeding performance in preterm infants.
M Boiron, L Da Nobrega, S Roux...
https://pubmed.ncbi.nlm.nih.gov/17518930