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

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.