A Phase 1 interventional study of Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care. in Drug Safety, sponsored by Polish Mother Memorial Hospital Research Institute. Not yet recruiting at 1 site in Poland. Open to participants aged Up to 30 Weeks. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Polish Mother Memorial Hospital Research Institute · Phase 1, Interventional, and Other
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:
Researchers will compare the intervention group with a comparison group of the patients who will receive routine comfort care.
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:
Comfort Measures:
Monitoring:
Control Group (non-midazolam group)
Monitoring:
In both groups, observations for:
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 40 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Polish Mother Memorial Hospital Research Institute is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
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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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.
Control Group (non-midazolam group) * No midazolam administered. * Routine comfort care
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)
Also known as: nasal midazolam
Pain assessment pre and post intranasal midazolam administration
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.
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
Evaluation of clinical safety of intranasal midazolam using a nasal atomizer (DART™ intranasal atomisation device) in newborns/infants.
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.
Time frame: Neonatal Adverse Event Severity Scale (NAESS) will be reported up to 24 hours following drug administration.
Sedation assessment after intranasal midazolam 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
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.
Plan to share: No
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Polish Mother Memorial Hospital Research Institute