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

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Study First Submitted: 2019-03-31
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-09
• Last Update Submitted: 2019-04-09
• Study First Posted: 2019-04-11
• Last Update Posted: 2019-04-11

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

Name	Time	Method
Days of enteral nutrition	Up to 46 weeks
Total length of hospitalization	Up to 46 weeks
Head circumference at discharge (cm)	Up to 46 weeks
Gestational age at the initiation of oral feeding	Up 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

Trial Locations

Locations (1)

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