Infant, Premature Clinical Trial
Official title:
Effects of the Oral Stimulation Program in Extreme Preterm Infants: A Randomized Clinical Trial
Verified date | August 2017 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
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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