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/30851536/Actively Recruiting
Led by Fundació Sant Joan de Déu · Updated on 2024-05-02
35
Participants Needed
1
Research Sites
30 weeks
Total Duration
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
Effects of the Application of PIOMI in the Oral Feeding of Premature
R
Raquel García Equerra
V
Vanesa Ejarque Marin
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Fundació Sant Joan de Déu
Lead Sponsor
Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
Collaborating Sponsor