Effects of the Oral Stimulation Program in Extreme Preterm Infants
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 2, 2017
CompletedFirst Posted
Study publicly available on registry
January 20, 2017
CompletedAugust 21, 2017
August 1, 2017
1.7 years
January 2, 2017
August 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oral feeding performance
The volume transfer is as considered as the percentage of the volume consumed (%).
20 minutes
Secondary Outcomes (2)
Oral feeding transition time
60 days
Days hospital stay
6 months
Study Arms (2)
Intervention group
EXPERIMENTALOral 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.
Control group
SHAM COMPARATORsham stimulation program consists of the same researcher placing her hands for 15 minutes.
Interventions
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.
Eligibility Criteria
You may qualify if:
- infants with between 26 and 32 weeks gestational age as determined by date of last menstruation and first trimester ultrasound or by clinical examination.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (1)
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.
PMID: 32903261DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rita C Silveira, Professor
Neonatal Section
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2017
First Posted
January 20, 2017
Study Start
May 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
August 21, 2017
Record last verified: 2017-08