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

NCT05530733 | Completed

• 1 other identifier: BEU-YTASDELEN-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature; Pacifiers; Tube Feeding; Neonatal Nursing

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (3)

Pacifier only

OTHER

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

Pacifier with breast milk

OTHER

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

standard care (no pacifier)

NO INTERVENTION

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.

Interventions

Pacifier PROCEDURE

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.

Pacifier only; Pacifier with breast milk

Breast milk PROCEDURE

For babies assigned to the pacifier with breast milk group, their own breast milk will be applied by dripping 1 ml into the pacifier.

Pacifier with breast milk

Eligibility Criteria

• Age: 29 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Yeliz Taşdelen

Zonguldak, Kozlu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Pacifiers; Milk, Human

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Infant Equipment; Equipment and Supplies; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Nurse, Research assistant

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 7, 2022
• Study Start: June 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 15, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)