Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding

Conditions
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Premature, Pacifiers, Tube Feeding, Neonatal Nursing

Intervention / Treatment
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* Procedure: Pacifier
* Procedure: Breast milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Feeding with the orogastric tube 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: Receiving mechanical ventilator support Development of sepsis Presence of neurological disease Presence of chromosomal or congenital anomalies Presence of intraventricular bleeding Unstable physiological parameters No breast milk

Ages Eligible for Study
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Minimum Age: 29 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pacifier only<br>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<br>* 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.<br>|
| Other: Pacifier with breast milk<br>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<br>* 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.<br>Procedure: Breast milk<br>* For babies assigned to the pacifier with breast milk group, their own breast milk will be applied by dripping 1 ml into the pacifier.<br>|
| No Intervention: standard care (no pacifier)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | measured with a stopwatch for 7 months. | 
| Gastric residual volume | Gastric residue will be measured 2 hours after the end of infant feeding. | Gastric residue will be measured 2 hours after the end of infant feeding. |