Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration
Launched by NURGÜL TEKIN · Mar 10, 2024
Trial Information
Current as of July 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how using a soft, crocheted octopus can help reduce pain and increase comfort for premature infants during a medical procedure called endotracheal aspiration, which is needed for babies on breathing support. The trial will take place in a neonatal intensive care unit, where babies born between 26 and 36 weeks of gestation will be eligible to participate. To be included, babies must be between 0 and 5 days old, need help with breathing, and must not have received any pain medication in the last four hours or undergone another painful procedure in the last two hours.
During the trial, some babies will receive the octopus toy to hold 10 minutes before and during the aspiration procedure, while others will not receive any special treatment. Nurses will carefully monitor and record the babies' comfort and pain levels throughout the process. The goal of the study is to see if the octopus can make the experience less painful for these vulnerable infants, helping to improve their overall comfort during a stressful time.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Gestational age range of 26-36 weeks
- • The baby should be between postnatal day 0 and 5 (Postnatal day of baby should be between 0 and 5 days.)
- • Need for invasive mechanical ventilator support
- • Need for endotracheal aspiration
- • No analgesic, opioid and sedative medication was applied within the 4 hours before the endotracheal aspiration
- • At least 2 hours passed since the last painful procedure
- Exclusion Criteria:
- • Receiving analgesic medication
- • Major congenital anomaly
- • Having a pneumothorax tube
- • Stage III and intraparenchymal hemorrhage
- • Receiving a sedative medication
About Nurgül Tekin
Nurgül Tekin is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative study designs and rigorous methodologies. With a focus on ethical practices and compliance with regulatory standards, Nurgül Tekin collaborates with healthcare professionals and research institutions to facilitate trials across various therapeutic areas. Through a patient-centric approach, the organization aims to enhance the understanding of diseases and the efficacy of new treatments, ultimately contributing to the betterment of public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported