NCT03025815

Effects of the Oral Stimulation Program in Extreme Preterm Infants

Effects of the Oral Stimulation Program in Extreme Preterm Infants: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 26 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Infant, Premature
• Feeding Behavior

Interventions

Type	Name	Description
OTHER	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.
OTHER	Control group	sham stimulation program consists of the same researcher placing her hands for 15 minutes.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2017-01-20
• Last updated: 2017-08-21

Locations

1 site across 1 country: Brazil