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Effects of the Oral Stimulation Program in Extreme Preterm Infants: A Randomized Clinical Trial (NCT03025815)

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.
  • 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.
    • Oral stimulation program
  • Other: Control group
    sham stimulation program consists of the same researcher placing her hands for 15 minutes.
    • Sham stimulation program
Ages eligible for Study
26 Weeks to 32 Weeks
Genders eligible for Study
All
Accepts Healthy Volunteers
No
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.
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.

1 locations

Brazil (1)
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul, Brazil
Status:
completed
Type:
Interventional
Phase:
-
Start:
30 April, 2015
Updated:
16 January, 2017
Participants:
74
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