Effects of the Oral Stimulation Program in Extreme Preterm Infants: A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infant, Premature
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Oral feeding performance
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Oral feeding performance
Time Frame: 20 minutes
The volume transfer is as considered as the percentage of the volume consumed (%).
Secondary Outcomes
- Oral feeding transition time(60 days)
- Days hospital stay(6 months)