Effects of the Oral Stimulation Program in Extreme Preterm Infants

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

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-01-31

Brief Summary

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

The purpose of this study is to determine whether oral stimulation program are effective to improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized classification of the subjects into to experimental and a control group.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Oral Stimulation in Preterm Infants

NCT03911674

Premature Infant Eating Disorder

COMPLETED PHASE3

Efficacy of an Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition

NCT03016767

Infant, Premature, Diseases

COMPLETED NA

Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants

NCT01116765

Preterm Infants

COMPLETED NA

Combined Oral Motor Stimulation and Language on Preterm Infant Feeding

NCT05861531

Language Delay Language Development Feeding; Difficult, Newborn +2 more

RECRUITING NA

Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

NCT02508571

Premature Birth of Newborn Intervention Studies

COMPLETED NA

Detailed Description

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

Recent studies have suggested that an oral stimulation program applied to preterm infants facilitates their oral feeding progress, improve breastfeeding rates in preterm infants and decreases the length of hospital stay. The objective of this study will evaluate the effect an oral stimulation program on the performance feeding, the length of the transition oral feeding, length of hospital stay and breastfeeding rates upon discharge.

Primarily, will be evaluated the effect an oral stimulation program on the performance feeding. All infants will be assessed by a speech pathologist blinded as to the group randomization.

Secondarily, will be observed the length of the transition oral feeding of the preterm infants, conducted by medical team and will be observed length of hospital stay. Both groups will be monitored from when they were assigned to participate in the study until hospital discharge.

All statistical will be conducted using Statistical Package for Social Sciences® version 18.0. The data will be analyzed for treatment group differences with chi-square or Fisher's exact tests for the categorical variables and with non-parametric tests for the continuous variables.

Conditions

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

Infant, Premature Feeding Behavior

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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

Intervention group

Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.

Group Type EXPERIMENTAL

Intervention group

Intervention Type OTHER

Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.

Control group

sham stimulation program consists of the same researcher placing her hands for 15 minutes.

Group Type SHAM_COMPARATOR

Control group

Intervention Type OTHER

sham stimulation program consists of the same researcher placing her hands for 15 minutes.

Interventions

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

Intervention group

Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.

Intervention Type OTHER

Control group

sham stimulation program consists of the same researcher placing her hands for 15 minutes.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Oral stimulation program Sham stimulation program

Eligibility Criteria

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

Inclusion Criteria

* infants with between 26 and 32 weeks gestational age as determined by date of last menstruation and first trimester ultrasound or by clinical examination.

Exclusion Criteria

* infants with medical complications, such as grades III or IV intraventricular hemorrhage or periventricular leukomalacia
* congenital diseases such as chromosomal or genetic abnormalities
* bronchopulmonary dysplasia
* necrotizing enterocolitis.

Minimum Eligible Age

26 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No