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Effects of Oral Stimulation in Preterm Infants

Phase 3
Completed
Conditions
Premature Infant
Eating Disorder
Registration Number
NCT03911674
Lead Sponsor
CEU San Pablo University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
Inclusion Criteria
  • Preterm infants with gestational age inferior to 34 weeks
Exclusion Criteria
  • Instability caused by respiratory, cardiac or gastrointestinal issues
  • Orofacial malformations.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Days of enteral nutritionUp to 46 weeks
Total length of hospitalizationUp to 46 weeks
Head circumference at discharge (cm)Up to 46 weeks
Gestational age at the initiation of oral feedingUp to 46 weeks
Gestational age at discharge (weeks)Up to 46 weeks
Weight at discharge (g)Up to 46 weeks
Height at discharge (cm)Up to 46 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

CEU San Pablo University

🇪🇸

Madrid, Comunidad De Madrid, Spain

CEU San Pablo University
🇪🇸Madrid, Comunidad De Madrid, Spain

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