An interventional study of Intervention group and Control group in Infant, Premature and Feeding Behavior, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 26 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2017-08-21.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Supportive care
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 74 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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: Intervention group
sham stimulation program consists of the same researcher placing her hands for 15 minutes.
Other: Control 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.
Also known as: Oral stimulation program
sham stimulation program consists of the same researcher placing her hands for 15 minutes.
Also known as: Sham stimulation program
Oral feeding performance
The volume transfer is as considered as the percentage of the volume consumed (%).
Time frame: 20 minutes
Oral feeding transition time
number of days
Time frame: 60 days
Days hospital stay
number of days
Time frame: 6 months
Plan to share: Undecided
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas de Porto Alegre