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Clinical Trials/NCT04290338
NCT04290338
Unknown
Not Applicable

Effects of the Premature Infant Oral Motor Intervention on the Oral Feeding Skills of the Premature Infants: A Randomized Controlled Trial

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico0 sites40 target enrollmentMarch 2020
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ConditionsFeeding Disorder Neonatal

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Feeding Disorder Neonatal
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Enrollment
40
Primary Endpoint
Mean volume
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Randomized controlled clinical trial aimed at evaluating the effects of the "Premature infant oral motor intervention" method on the oral feeding skills of the premature infants.

Detailed Description

Numerous evidences emerge from the literature review on the usefulness of the PIOMI method to improve food skills in the premature infant. The goal of this study is to evaluate the effects of the PIOMI method by adding the gustatory stimulation to the original protocol.

Registry
clinicaltrials.gov
Start Date
March 2020
End Date
September 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •gestational age at birth between 25-33 weeks;
  • •clinical stability;
  • •possible presence of nasogastric or oro-gastric tube;
  • •non-invasive respiratory support (oxygen, high flows)

Exclusion Criteria

  • •gestational age \<25 weeks or\> 33 weeks
  • •absence of clinical stability
  • •invasive respiratory support (CPAP)
  • •previous surgical interventions
  • •ongoing infections
  • •congenital and / or chromosomal diseases
  • •brain, metabolic, cardiac, gastrointestinal diseases
  • •presence of bronchopulmonary dysplasia

Outcomes

Primary Outcomes

Mean volume

Time Frame: 7 days

Mean volume of oral intake

Secondary Outcomes

  • feeding efficiency(3 days)
  • achievement of full oral feeding(6 moths)
  • hospital stay time(6 months)
  • transition time(6 months)

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