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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03025815
Other study ID # 41366915.5.0000.5327
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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