- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03911674
Effects of Oral Stimulation in Preterm Infants
Effects of Oral Stimulation on Feeding Performance, Length of Hospital Stay and Anthropometric Variables of Preterm Infants
Preterm infants with gestational age inferior to 34 weeks were included in the study. A prospective experimental group received the oral stimulation protocol and the effects of the intervention were compared with a historical control group that did not receive any oral stimulation intervention.
The study hypothesis is that oral stimulation in preterm infants has beneficial effects on the feeding performance, the length of hospitalization and anthropometric variables, including weight at discharge, height at discharge and head circumference at discharge.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Comunidad De Madrid
-
Madrid, Comunidad De Madrid, Spain, 28668
- CEU San Pablo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Preterm infants with gestational age inferior to 34 weeks
Exclusion Criteria:
- Instability caused by respiratory, cardiac or gastrointestinal issues
- Orofacial malformations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Oral stimulation
Oral stimulation protocol: manual stimulation of the oral sucking
|
Manual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin.
|
NO_INTERVENTION: Control
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gestational age at the initiation of oral feeding
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
Weight at discharge (g)
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
Height at discharge (cm)
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
Head circumference at discharge (cm)
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
Days of enteral nutrition
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
Gestational age at discharge (weeks)
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
Total length of hospitalization
Time Frame: Up to 46 weeks
|
Up to 46 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEU-0013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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