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Effects of Oral Stimulation in Preterm Infants

Primary Purpose

Premature Infant, Eating Disorder

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Oral manual stimulation of feeding in preterm infants
Sponsored by
CEU San Pablo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Infant

Eligibility Criteria

undefined - 7 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Preterm infants with gestational age inferior to 34 weeks

Exclusion Criteria:

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

Sites / Locations

  • CEU San Pablo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oral stimulation

Control

Arm Description

Oral stimulation protocol: manual stimulation of the oral sucking

No intervention

Outcomes

Primary Outcome Measures

Gestational age at the initiation of oral feeding
Weight at discharge (g)
Height at discharge (cm)
Head circumference at discharge (cm)
Days of enteral nutrition
Gestational age at discharge (weeks)
Total length of hospitalization

Secondary Outcome Measures

Full Information

First Posted
March 31, 2019
Last Updated
April 9, 2019
Sponsor
CEU San Pablo University
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1. Study Identification

Unique Protocol Identification Number
NCT03911674
Brief Title
Effects of Oral Stimulation in Preterm Infants
Official Title
Effects of Oral Stimulation on Feeding Performance, Length of Hospital Stay and Anthropometric Variables of Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEU San Pablo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant, Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral stimulation
Arm Type
Experimental
Arm Description
Oral stimulation protocol: manual stimulation of the oral sucking
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Oral manual stimulation of feeding in preterm infants
Intervention Description
Manual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin.
Primary Outcome Measure Information:
Title
Gestational age at the initiation of oral feeding
Time Frame
Up to 46 weeks
Title
Weight at discharge (g)
Time Frame
Up to 46 weeks
Title
Height at discharge (cm)
Time Frame
Up to 46 weeks
Title
Head circumference at discharge (cm)
Time Frame
Up to 46 weeks
Title
Days of enteral nutrition
Time Frame
Up to 46 weeks
Title
Gestational age at discharge (weeks)
Time Frame
Up to 46 weeks
Title
Total length of hospitalization
Time Frame
Up to 46 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
CEU San Pablo University
City
Madrid
State/Province
Comunidad De Madrid
ZIP/Postal Code
28668
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Oral Stimulation in Preterm Infants

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