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 type | Interventional |
|---|---|
| Ages | 28 Weeks to 34 Weeks |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Hasan Kalyoncu University Academic / other |
| Locations | 1 site (Batman) |
| Status | Recruiting |
| Started | October 15, 2024 |
| Main results expected | May 15, 2025 |
| Study ends | July 15, 2025 |
| Registry record updated | March 14, 2025 |
| Trial ID | NCT06832553 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
- Principal investigator: Barış Çelik — Hasan Kalyoncu University
- Study coordinator: Barış Çelik
- Email: c.celikbaris@gmail.com
- Phone: 5424283452
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Premature infants: trying PIOMI with mom to support feeding
Aims to see if PIOMI done with a mother’s presence and voice helps preterm babies feed better and feel more connected to mom.
-
SAFE early intervention for high-risk infants to support arm function
This randomized trial tests whether the SAFE early intervention helps improve upper limb function and early development in high-risk infants aged 3–12 months compared with standard Neurodevelopmental Treatment (NDT).
-
PIMUN to reduce low-oxygen episodes in preterm infants
We will test whether PIMUN, a soft garment that gives gentle pulsatile dorsal stimulation, can reduce low-oxygen (SpO2 <90%) episodes in preterm infants born at 24–34 weeks who have apnea of prematurity.
-
Cerclage plus progesterone versus progesterone alone for twins with a short cervix
This will test whether adding a cervical stitch (cerclage) to progesterone helps prevent early birth in people carrying twins who have a short cervix (≤30 mm).
-
Helping preterm babies learn to feed using scheduled pacifier use
This study tests whether giving preterm babies a 5-minute pacifier before each feeding versus a 30-minute pacifier at random times helps them develop feeding skills faster and leave the hospital sooner.
-
Early physiotherapy to improve motor optimality in at-risk infants
This trial will test whether starting a targeted physiotherapy program early improves motor movement scores in infants born preterm or who had serious neonatal complications.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.