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NCT Number: NCT06889376

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

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.

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Key information

Conditions

Drug Safety Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 30 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Polish Mother's Health Center Institute Rzgowska 281/289, 93-338 Lodz

Lodz, 93-338, Poland

Location contact

Agnieszka Nowacka, Lek. med

PRINCIPAL_INVESTIGATOR

Agnieszka Nowacka, Lek. med.

CONTACT

[email protected]

+48607603226

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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 min before screening.
  • Swaddling and placement under the radiant warmer.

Monitoring:

  • Vital Signs (heart rate, respiratory rate, blood pressure, oxygen saturation monitoring before drug administration until 2 hours after).
  • Pain assessment (PIPP scale) conducted before, during, and 10 and 30 min post-procedure.
  • Modified N-PASS to assess the level of sedation conducted before, during, 10, 30 minutes 1 hour and 2 hours post-procedure

Observations for signs of:

  • 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)

Other names: nasal midazolam

Primary outcomes

  1. Pain assessment pre and post intranasal midazolam administration

    Time frame: PIPP Score Assessment Time Points: 5 minutes before drug administration, during drug administration, 10, 30 minutes 1 hour and 2 hours post-procedure

    Primary Endpoint:

    • Change in the occurrence of pain symptoms and stress associated with screening ophthalmologic examination (ROP).

    Use of Premature Infant Pain Profile (PIPP) score

    • Purpose: To evaluate pain and stress responses before, during, and after the procedure.
    • Scoring Components:
    • Heart rate changes.
    • Oxygen saturation levels.
    • Facial expressions (brow bulge, eye squeeze, nasolabial furrow).
    • Behavioural state (awake, fussy, crying).
    • Gestational age adjustment.

Secondary outcomes

  1. Evaluation of clinical safety of intranasal midazolam using a nasal atomizer (DART™ intranasal atomisation device) in newborns/infants.

    Time frame: Neonatal Adverse Event Severity Scale (NAESS) will be reported up to 24 hours following drug administration.

    To accurately report the adverse events during intranasal midazolam administration using a nasal atomizer (DART™ intranasal atomisation device) in newborns/infants, the Neonatal Adverse Event Severity Scale (NAESS) will be used.

    This scale contains generic severity criteria that can occur in neonates, followed by a list of 35 specific medical conditions: neurological, cardiovascular, respiratory, gastrointestinal, infectious, general and any other symptoms

    Each of the criteria is divided into grading system:

    Grade 1 - Mild Grade 2 - Moderate Grade 3 - Severe Grade 4 - Life- threatening Grade 5 - Death Assessment of the severity of the adverse event is based on the observation of the changes in the following components: age appropriate behavioural changes, changes from the baseline in the vital signs, changes in the required care and monitoring. Only changes from the baseline condition will be considered as a reported adverse-events.

  2. Sedation assessment after intranasal midazolam administration.

    Time frame: 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.

    To assess the sedation status after intranasal midazolam administration, Modified N-PASS: Neonatal Sedation Assessment Scale will be used.

    The assessment criteria of the scale include:

    • Crying/ Irritability
    • Behaviour State
    • Facial Expression
    • Extremities Tone
    • Vital Signs: HR, RR, BP, SaO2 Each of the criteria scores from 0 to -2, the sum provides a total score and note as a negative score (0 to -10).

    Deep sedation: -10 to -6 Light sedation: -5 to - 2 Normal: -1 to +3

Study contacts

Contact information is provided by the study sponsor or research team.

Agnieszka Nowacka, MSc

CONTACT

[email protected]

+48 607603226

Sponsors and collaborators

Lead sponsor

Polish Mother Memorial Hospital Research Institute

Other

Registry information

Official study title

The Use of Intranasal Sedation With Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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