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Clinical Trials/NCT03911674
NCT03911674
Completed
Phase 3

Effects of Oral Stimulation on Feeding Performance, Length of Hospital Stay and Anthropometric Variables of Preterm Infants

CEU San Pablo University1 site in 1 country48 target enrollmentSeptember 1, 2017

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Premature Infant
Sponsor
CEU San Pablo University
Enrollment
48
Locations
1
Primary Endpoint
Days of enteral nutrition
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
April 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
CEU San Pablo University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Preterm infants with gestational age inferior to 34 weeks

Exclusion Criteria

  • Instability caused by respiratory, cardiac or gastrointestinal issues
  • Orofacial malformations.

Outcomes

Primary Outcomes

Days of enteral nutrition

Time Frame: Up to 46 weeks

Total length of hospitalization

Time Frame: Up to 46 weeks

Weight at discharge (g)

Time Frame: Up to 46 weeks

Height at discharge (cm)

Time Frame: Up to 46 weeks

Head circumference at discharge (cm)

Time Frame: Up to 46 weeks

Gestational age at the initiation of oral feeding

Time Frame: Up to 46 weeks

Gestational age at discharge (weeks)

Time Frame: Up to 46 weeks

Study Sites (1)

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