Effects of Oral Stimulation in Preterm Infants

April 9, 2019 updated by: CEU San Pablo University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Comunidad De Madrid
      • Madrid, Comunidad De Madrid, Spain, 28668
        • CEU San Pablo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Preterm infants with gestational age inferior to 34 weeks

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oral stimulation
Oral stimulation protocol: manual stimulation of the oral sucking
Other: Oral manual stimulation of feeding in preterm infants
Manual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin.
NO_INTERVENTION: Control
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gestational age at the initiation of oral feeding
Time Frame: Up to 46 weeks
Up to 46 weeks
Weight at discharge (g)
Time Frame: Up to 46 weeks
Up to 46 weeks
Height at discharge (cm)
Time Frame: Up to 46 weeks
Up to 46 weeks
Head circumference at discharge (cm)
Time Frame: Up to 46 weeks
Up to 46 weeks
Days of enteral nutrition
Time Frame: Up to 46 weeks
Up to 46 weeks
Gestational age at discharge (weeks)
Time Frame: Up to 46 weeks
Up to 46 weeks
Total length of hospitalization
Time Frame: Up to 46 weeks
Up to 46 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CEU San Pablo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

April 1, 2018

Study Registration Dates

First Submitted

March 31, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (ACTUAL)

April 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEU-0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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