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

Polish Mother Memorial Hospital Research Institute

Status and phase: Not yet enrolling; Phase 1

Conditions: Drug Safety

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06889376

98/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 30 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intranasal midazolam and comfort care

Experimental group

Description:

The newborn/infant qualified for the ROP screening will receive intranasal midazolam before the procedure using a nasal atomizer. The newborn/infant will also receive comfort care

Treatment:

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

Control group

No Intervention group

Description:

Control Group (non-midazolam group) * No midazolam administered. * Routine comfort care