Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
Launched by POLISH MOTHER MEMORIAL HOSPITAL RESEARCH INSTITUTE · Mar 16, 2025
Trial Information
Current as of April 29, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the use of a medication called intranasal midazolam to help reduce stress and pain in premature infants during a routine eye exam known as Retinopathy of Prematurity (ROP) screening. The main goal is to find out if this quick and non-invasive treatment can safely make the experience more comfortable for these vulnerable babies. Researchers will compare infants who receive midazolam with those who get standard comfort care to see if there are any differences in how they respond to the exam.
To participate in this trial, infants must be newborns who were born prematurely (before 32 weeks of pregnancy) or have a low birth weight (less than 1500 grams). Parents or guardians will need to give their permission for their child to join. However, infants who are not stable enough for the exam, have certain health issues, or are already receiving other pain medications will not be eligible. If your baby qualifies and participates, you can expect close monitoring to ensure their safety throughout the study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Newborns qualified for ophthalmologic screening examination to detect retinopathy of prematurity (ROP):
- • a. Newborns/infants born before the 32 weeks of gestation and/or with a birth weight \<1500 g.
- • Obtaining informed consent from a parent/legal guardian.
- Exclusion Criteria:
- • Newborns/infants not qualified for screening ophthalmologic examination (ROP).
- • Newborns/infants clinically unstable, with respiratory disorders/cardiovascular instability before the ophthalmologic examination.
- • Newborns/infants with congenital developmental defects.
- • Newborns/infants receiving analgesic/sedative medications for other reasons.
About Polish Mother Memorial Hospital Research Institute
The Polish Mother Memorial Hospital Research Institute is a leading clinical research organization dedicated to advancing medical knowledge and improving patient care through innovative research initiatives. As a prominent healthcare institution, it specializes in maternal and pediatric health, leveraging its extensive clinical expertise and state-of-the-art facilities to conduct rigorous clinical trials. The Institute collaborates with a network of healthcare professionals and researchers to evaluate new therapies, enhance treatment protocols, and contribute to the scientific community, ultimately aiming to optimize health outcomes for mothers and children in Poland and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lodz, , Poland
Patients applied
Trial Officials
Ewa Gulczyńska, Professor
Study Chair
Polish Mother's Health Center Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported