Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding: Randomized Controlled Trial
NCT ID: NCT05530733
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2022-06-01
2024-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Pacifier only
Participants in the pacifier-only group will get a pacifier five minutes prior to tube feeding. During feedings, a pacifier will be employed. Five minutes following the end of tube feeding, the pacifier application will be discontinued. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the volume of gastric residue will be controlled.
Pacifier
Pacifiers produced for premature babies will be used in the study. Pacifiers will be made of silicone material suitable for premature baby health and will not contain any harmful substances. A separate pacifier will be used for each baby, and pacifiers will be sterilized before use.
Pacifier with breast milk
Five minutes prior to tube feeding, participants in the pacifier with breast milk group will get their own breast milk dripping pacifier. During feedings, a pacifier will be employed. Five minutes following the end of tube feeding, the pacifier application will be discontinued. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the amount of gastric residue will be controlled.
Pacifier
Pacifiers produced for premature babies will be used in the study. Pacifiers will be made of silicone material suitable for premature baby health and will not contain any harmful substances. A separate pacifier will be used for each baby, and pacifiers will be sterilized before use.
Breast milk
For babies assigned to the pacifier with breast milk group, their own breast milk will be applied by dripping 1 ml into the pacifier.
standard care (no pacifier)
The premature babies in the standard care (no pacifier) will get standard care while being fed through an orogastric tube. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the amount of gastric residue will be controlled.
No interventions assigned to this group
Interventions
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Pacifier
Pacifiers produced for premature babies will be used in the study. Pacifiers will be made of silicone material suitable for premature baby health and will not contain any harmful substances. A separate pacifier will be used for each baby, and pacifiers will be sterilized before use.
Breast milk
For babies assigned to the pacifier with breast milk group, their own breast milk will be applied by dripping 1 ml into the pacifier.
Eligibility Criteria
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Inclusion Criteria
* Breastmilk along with formula (babies who receive more than 50% of their total feed in 24 hours from formula)
* Gestation week between 29+0 weeks and 34+0 weeks
* Weight of 1000 g or more
Exclusion Criteria
* Development of sepsis
* Presence of neurological disease
* Presence of chromosomal or congenital anomalies
* Presence of intraventricular bleeding
* Unstable physiological parameters
* No breast milk
29 Weeks
34 Weeks
ALL
No
Sponsors
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Zonguldak Bulent Ecevit University
OTHER
Responsible Party
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Yeliz Taşdelen
Principal investigator, Nurse, Research assistant
Locations
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Yeliz Taşdelen
Zonguldak, Kozlu, Turkey (Türkiye)
Countries
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Other Identifiers
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BEU-YTASDELEN-001
Identifier Type: -
Identifier Source: org_study_id
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