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Completed

NCT Number: NCT05530733

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

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.

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Key information

Conditions

Premature Female Urogenital Diseases and Pregnancy Complications Neonatal Nursing Obstetric Labor Complications Obstetric Labor, Premature Pacifiers Pregnancy Complications Premature Birth Tube Feeding Urogenital Diseases

Age range

29 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeliz Taşdelen

Zonguldak, Kozlu, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Heart rate change

    Time frame: 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.

  2. Respiratory rate change

    Time frame: 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.

  3. Saturation level change

    Time frame: 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.

  4. Feeding duration

    Time frame: measured with a stopwatch for 7 months.

    Each baby's tube feeding duration will be measured.

  5. Gastric residual volume

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2022
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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