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

Zonguldak Bulent Ecevit University

Status: Completed

Conditions: Premature; Pacifiers; Neonatal Nursing; Tube Feeding

Treatments: Procedure: Pacifier; Procedure: Breast milk

Study type: Interventional

Funder types: Other

Identifiers

NCT05530733

BEU-YTASDELEN-001

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 29 to 34 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Pacifier only

Other group

Description:

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.

Treatment:

Procedure: Pacifier

Pacifier with breast milk

Other group

Description:

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.

Treatment:

Procedure: Breast milk

Procedure: Pacifier

standard care (no pacifier)

No Intervention group

Description:

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.