An interventional study of Pacifier and Breast milk in Premature, Pacifiers and Tube Feeding, sponsored by Zonguldak Bulent Ecevit University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 29 Weeks to 34 Weeks. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Zonguldak Bulent Ecevit University · Not applicable, Interventional, and Supportive care
The purpose of the study was to assess how preterm babies' vital signs, feeding time, and gastric residual volume were affected by using a pacifier only or a pacifier with breast milk during orogastric tube feeding.
2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 90 is close to the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Zonguldak Bulent Ecevit University is the lead sponsor of 99 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Pacifier
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.
Procedure: Pacifier · Procedure: Breast milk
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.
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.
For babies assigned to the pacifier with breast milk group, their own breast milk will be applied by dripping 1 ml into the pacifier.
Heart rate change
Heart rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Time frame: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
Respiratory rate change
Respiratory rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Time frame: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
Saturation level change
Saturation level will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Time frame: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
Feeding duration
Each baby's tube feeding duration will be measured.
Time frame: measured with a stopwatch for 7 months.
Gastric residual volume
Gastric residue will be measured 2 hours after the end of infant feeding.
Time frame: Gastric residue will be measured 2 hours after the end of infant feeding.
Plan to share: No
Ran from Jun 2022 to primary completion in Feb 2024, 20 months.
Of 753 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 20 months is below that.
Counting every sponsor, half of 775 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Zonguldak Bulent Ecevit University