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Clinical Trials/NCT03911674
NCT03911674CompletedPhase 3

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

CEU San Pablo University2 sites in 1 country48 target enrollmentStarted: September 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
48
Locations
2
Primary Endpoint
Days of enteral nutrition

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 7 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Preterm infants with gestational age inferior to 34 weeks

Exclusion Criteria

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

Arms & Interventions

Oral stimulation

Experimental

Oral stimulation protocol: manual stimulation of the oral sucking

Intervention: Oral manual stimulation of feeding in preterm infants (Other)

Control

No Intervention

No intervention

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
CEU San Pablo University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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