Effects of the Oral Stimulation Program in Extreme Preterm Infants

Infant, Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025815
• Other study ID #: 41366915.5.0000.5327
• Status: Completed
• Phase: N/A
• First received: January 2, 2017
• Last updated: August 16, 2017
• Start date: May 2015
• Est. completion date: January 2017

Study information

• Verified date: August 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Weeks to 32 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Feeding Behavior
• Infant, Premature

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral feeding performance	The volume transfer is as considered as the percentage of the volume consumed (%).	20 minutes
Secondary	Oral feeding transition time	number of days	60 days
Secondary	Days hospital stay	number of days	6 months