Clinical trial Recruiting at 1 site Interventional Ages 28 Weeks to 34 Weeks

Using surgical drapes to secure endotracheal tubes in preterm infants

Official title: The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation in Neonatal Preterm Infants: A Randomized Controlled Trial

Run by Hasan Kalyoncu University · NCT06832553 · Data updated 2026-11-12

This study is testing if using surgical drapes to hold endotracheal tubes in place can help preterm infants avoid accidental tube removal and skin damage compared to regular methods.

Quick facts

Study typeInterventional
Ages28 Weeks to 34 Weeks
SexAll
Enrollment110 (estimated)
SponsorHasan Kalyoncu University
Academic / other
Locations1 site (Batman)
StatusRecruiting
StartedOctober 15, 2024
Main results expectedMay 15, 2025
Study endsJuly 15, 2025
Registry record updatedMarch 14, 2025
Trial IDNCT06832553 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are preterm infants between 28-34 weeks of gestation who are hospitalized and intubated in a neonatal intensive care unit.

Probably not a fit

Patients with congenital skin conditions, circulatory problems, or those intubated for less than 24 hours may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of surgical incision drapes for securing endotracheal tubes in preterm neonates. Conducted as a randomized controlled trial, participants will be divided into two groups: one using the surgical drape and the other using standard fixation methods. The study will focus on minimizing unplanned extubation and skin damage by measuring skin moisture, pH, and assessing skin condition in both groups. Data will be collected every 24 hours during the intubation period to evaluate the outcomes.

Why it matters

Potential benefit: If successful, this approach could significantly reduce complications related to endotracheal tube fixation in preterm infants.

How similar studies have gone: While similar approaches have been explored, this specific use of surgical drapes in this context is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Preterm infants between 28-34 weeks of gestation hospitalized in neonatal intensive care unit,
* Intubated infants on invasive mechanical ventilators,
* Babies who were orally intubated were included in the study.

Exclusion Criteria:

* Congenital skin condition,
* With circulatory problems,
* Congenital anomalies and metabolic disorders,
* Small for gestational age (SGA) and large for gestational age (LGA),
* Unplanned extubation taking place,
* Babies intubated for less than 24 hours will be excluded from the study.

Where it's running

  • Barış Çelik
    Batman, Turkey (Türkiye)
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.