Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.

ConditionDrug Safety
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorPolish Mother Memorial Hospital Research Institute

About this trial

The goal of this study is to learn about the safety and effectiveness of intranasal midazolam in newborns and infants born prematurely, undergoing Retinopathy of Prematurity (ROP) screening.

The main question it aims to answer is:

• Does use of intranasal midazolam is a safe, quick, non-invasive medication, that reduces the pain, stress, discomfort, and other complications in patients undergoing ROP screening?

Researchers will compare the intervention group with a comparison group of the patients who will receive routine comfort care.

Eligibility criteria

Qualifiers

Obtaining informed consent from a parent/legal guardian.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.

Treatment groups

40 Participants
are divided into 2 treatment groups