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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05530733
Enrollment
90
Registered
2022-09-07
Start date
2022-06-01
Completion date
2024-02-15
Last updated
2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Nursing, Pacifiers, Premature, Tube Feeding

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.

Interventions

PROCEDUREPacifier

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.

PROCEDUREBreast 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.

Sponsors

Zonguldak Bulent Ecevit University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
29 Weeks to 34 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Heart rate change5 minutes before tube feeding, during tube feeding and 5 minutes after tube feedingHeart rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Respiratory rate change5 minutes before tube feeding, during tube feeding and 5 minutes after tube feedingRespiratory rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Saturation level change5 minutes before tube feeding, during tube feeding and 5 minutes after tube feedingSaturation level will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Feeding durationmeasured with a stopwatch for 7 months.Each baby's tube feeding duration will be measured.
Gastric residual volumeGastric 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026