Effects of the Oral Stimulation Program in Extreme Preterm Infants

Not Applicable

Completed

• Conditions: Infant, Premature; Feeding Behavior
• Interventions: Other: Intervention group; Other: Control group

• Registration Number: NCT03025815
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	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.
Control group	Control group	sham stimulation program consists of the same researcher placing her hands for 15 minutes.

Primary Outcome Measures

Name	Time	Method
Oral feeding performance	20 minutes	The volume transfer is as considered as the percentage of the volume consumed (%).

Secondary Outcome Measures

Name	Time	Method
Oral feeding transition time	60 days	number of days
Days hospital stay	6 months	number of days

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil