Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding

Premature Clinical Trial

Official title:

Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05530733
• Other study ID #: BEU-YTASDELEN-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2022
• Source: Zonguldak Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Weeks to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature
• Tube Feeding

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Yeliz Tasdelen	Zonguldak	Kozlu

Sponsors (1)

Lead Sponsor	Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Feeding duration	Each baby's tube feeding duration will be measured.	measured with a stopwatch for 7 months.
Primary	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.