Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding: Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Tube Feeding; Pacifiers; Neonatal Nursing; Premature

• Registration Number: NCT05530733
• Lead Sponsor: Zonguldak Bulent Ecevit University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-07
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-10-13
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory rate change	5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding	Respiratory rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Saturation level change	5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding	Saturation level will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Feeding duration	measured with a stopwatch for 7 months.	Each baby's tube feeding duration will be measured.
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.
Heart rate change	5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding	Heart rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.

Trial Locations

Locations (1)

Yeliz Taşdelen; 🇹🇷 Zonguldak, Kozlu, Turkey