Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature; Tube Feeding; Pacifiers; Neonatal Nursing
• Intervention / Treatment: Procedure: Pacifier; Procedure: Breast milk

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kozlu
    • Zonguldak, Kozlu, Turkey
      • Yeliz Taşdelen
      • Contact: Aysel Topan, PhD, RN; Phone Number: +90 3722613394; Email: aysel.topan@beun.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 9 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
Other: 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.	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.; Procedure: 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.
No Intervention: 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Zonguldak Bulent Ecevit University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BEU-YTASDELEN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No