Clinical trial NCT06889376: Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
Official title: The Use of Intranasal Sedation With Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Drug Safety
Keywords: intranasal midazolam
ROP screening
Premature infants
Lead sponsor: Polish Mother Memorial Hospital Research Institute
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 40
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: The aim of this parallel, prospective, nonblinded randomised control trial is to assess the effectiveness and safety of intranasal midazolam administered before ROP screening using the DART™ intranasal atomization device in preterm newborns and infants.

Participants: Preterm newborns and infants eligible for routine ROP screening. Recruitment: Parental/legal guardian consent required before random assignment to either the study or control group.

Study Groups and Randomization:

Random Assignment: Block randomization will be used. • Sample Size: 40 newborns/infants (20 in control, 20 in study group).

Study intervention and monitoring:

• Study Group (midazolam group) Intervention: intranasal midazolam (0.2 mg/kg) administered 10 minutes before ROP screening via the DART™ intranasal atomization device.

Comfort Measures:

* 1 ml of 20% glucose solution orally with a pacifier, 5 minutes before screening.
* Swaddling and placement under the radiant warmer.

Monitoring:

* Vital signs: heart rate, respiratory rate, blood pressure, oxygen saturation recorded 10 minutes before screening until 2 hours post-examination.
* Pain assessment (PIPP scale) conducted before, during, and 10, 30 minutes 1 hour and 2 hours post-procedure.
* Modified N-PASS scale to assess the level of sedation conducted before, during, 10, 30 minutes 1 hour and 2 hours post-procedure.

Control Group (non-midazolam group)

* No midazolam administered.
* Comfort measures: 1 ml of 20% glucose solution orally with a pacifier 5 minutes before screening. Swaddling and placement under the radiant warmer.

Monitoring:

* Vital signs: heart rate, respiratory rate, blood pressure, oxygen saturation recorded 10 minutes before screening until 2 hours post-examination.
* Pain assessment (PIPP scale) conducted before, during, and 10, 30 minutes 1 hour and 2 hours post-procedure.

In both groups, observations for:

* Respiratory Distress (apnoea, desaturation, increased work of breathing)
* Cardiovascular Instability (Bradycardia, tachycardia, hypotension)
* Neurological Symptoms (Lethargy, seizures, abnormal tone)
* Gastrointestinal Issues (Feeding intolerance, NEC-like symptoms)
* Infections \& Sepsis (Confirmed or suspected based on clinical signs)

Study Outcome Assessment:

Change in pain and stress symptoms during ROP screening, measured by the Premature Infant Pain Profile (PIPP).

Clinical safety of intranasal midazolam using a nasal atomizer (DART™ intranasal atomization device) in newborns/infants.

Assessment of sedation post intranasal midazolam administration.

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.

Primary outcomes:
measure: Pain assessment pre and post intranasal midazolam administration
timeFrame: PIPP Score Assessment Time Points: 5 minutes before drug administration, during drug administration, 10, 30 minutes 1 hour and 2 hours post-procedure
Secondary outcomes:
measure: Evaluation of clinical safety of intranasal midazolam using a nasal atomizer (DART™ intranasal atomisation device) in newborns/infants.
timeFrame: Neonatal Adverse Event Severity Scale (NAESS) will be reported up to 24 hours following drug administration.
measure: Sedation assessment after intranasal midazolam administration.
timeFrame: Modified N-PASS score used to assess level of sedation time points: 5 minutes before drug administration, during drug administration, 10, 30 minutess, 1 hour and 2 hours post - drug administration.
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Polish Mother's Health Center Institute Rzgowska 281/289, 93-338 Lodz
Study officials:
affiliation: Polish Mother's Health Center Institute
name: Ewa Gulczyńska, Professor
role: STUDY_CHAIR
References:
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