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.
Obtaining informed consent from a parent/legal guardian.
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.
Parallel
Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.
DrugIntervention: 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)
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.
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.
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
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