Effects of the Oral Stimulation Program in Extreme Preterm Infants
Primary Purpose
Infant, Premature, Feeding Behavior
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intervention group
Control group
Sponsored by

About this trial
This is an interventional supportive care trial for Infant, Premature focused on measuring Infant, Premature
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.
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention group
Control group
Arm Description
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.
sham stimulation program consists of the same researcher placing her hands for 15 minutes.
Outcomes
Primary Outcome Measures
Oral feeding performance
The volume transfer is as considered as the percentage of the volume consumed (%).
Secondary Outcome Measures
Oral feeding transition time
number of days
Days hospital stay
number of days
Full Information
NCT ID
NCT03025815
First Posted
January 2, 2017
Last Updated
August 16, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03025815
Brief Title
Effects of the Oral Stimulation Program in Extreme Preterm Infants
Official Title
Effects of the Oral Stimulation Program in Extreme Preterm Infants: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Feeding Behavior
Keywords
Infant, Premature
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
sham stimulation program consists of the same researcher placing her hands for 15 minutes.
Intervention Type
Other
Intervention Name(s)
Intervention group
Other Intervention Name(s)
Oral stimulation program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
Sham stimulation program
Intervention Description
sham stimulation program consists of the same researcher placing her hands for 15 minutes.
Primary Outcome Measure Information:
Title
Oral feeding performance
Description
The volume transfer is as considered as the percentage of the volume consumed (%).
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Oral feeding transition time
Description
number of days
Time Frame
60 days
Title
Days hospital stay
Description
number of days
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita C Silveira, Professor
Organizational Affiliation
Neonatal Section
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32903261
Citation
da Rosa Pereira K, Levy DS, Procianoy RS, Silveira RC. Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial. PLoS One. 2020 Sep 9;15(9):e0237915. doi: 10.1371/journal.pone.0237915. eCollection 2020.
Results Reference
derived
Learn more about this trial
Effects of the Oral Stimulation Program in Extreme Preterm Infants
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