Effects of Oral Stimulation in Preterm Infants

NCT ID: NCT03911674

Last Updated: 2019-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Infant Eating Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral stimulation

Oral stimulation protocol: manual stimulation of the oral sucking

Group Type EXPERIMENTAL

Oral manual stimulation of feeding in preterm infants

Intervention Type OTHER

Manual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin.

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral manual stimulation of feeding in preterm infants

Manual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Preterm infants with gestational age inferior to 34 weeks

Exclusion Criteria

* Instability caused by respiratory, cardiac or gastrointestinal issues
* Orofacial malformations.
Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CEU San Pablo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CEU San Pablo University

Madrid, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEU-0013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.