Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
NCT ID: NCT06889376
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2025-03-24
2025-07-06
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intranasal midazolam and comfort care
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
Intranasal midazolam administration via the DART™ intranasal atomization device along with 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)
Control group
Control Group (non-midazolam group)
* No midazolam administered.
* Routine comfort care
No interventions assigned to this group
Interventions
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Intranasal midazolam administration via the DART™ intranasal atomization device along with 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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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.
30 Weeks
ALL
No
Sponsors
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Polish Mother Memorial Hospital Research Institute
OTHER
Responsible Party
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Agnieszka Nowacka
Principal Investigator, Senior Assistant at Neonatology Department
Principal Investigators
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Ewa Gulczyńska, Professor
Role: STUDY_CHAIR
Polish Mother's Health Center Institute
Locations
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Polish Mother's Health Center Institute Rzgowska 281/289, 93-338 Lodz
Lodz, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Salaets T, Lacaze-Masmonteil T, Hokuto I, Gauldin C, Taha A, Smits A, Thewissen L, Van Horebeek I, Shoraisham A, Mohammad K, Suzuki M, Komachi S, Michels K, Turner MA, Allegaert K, Lewis T. Prospective assessment of inter-rater reliability of a neonatal adverse event severity scale. Front Pharmacol. 2023 Sep 7;14:1237982. doi: 10.3389/fphar.2023.1237982. eCollection 2023.
Salaets T, Turner MA, Short M, Ward RM, Hokuto I, Ariagno RL, Klein A, Beauman S, Wade K, Thomson M, Roberts E, Harrison J, Quinn T, Baer G, Davis J, Allegaert K; International Neonatal Consortium. Development of a neonatal adverse event severity scale through a Delphi consensus approach. Arch Dis Child. 2019 Dec;104(12):1167-1173. doi: 10.1136/archdischild-2019-317399. Epub 2019 Sep 19.
Morgan ME, Kukora S, Nemshak M, Shuman CJ. Neonatal Pain, Agitation, and Sedation Scale's use, reliability, and validity: a systematic review. J Perinatol. 2020 Dec;40(12):1753-1763. doi: 10.1038/s41372-020-00840-7. Epub 2020 Oct 2.
Vinall J, Miller SP, Chau V, Brummelte S, Synnes AR, Grunau RE. Neonatal pain in relation to postnatal growth in infants born very preterm. Pain. 2012 Jul;153(7):1374-1381. doi: 10.1016/j.pain.2012.02.007.
COMMITTEE ON FETUS AND NEWBORN and SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE. Prevention and Management of Procedural Pain in the Neonate: An Update. Pediatrics. 2016 Feb;137(2):e20154271. doi: 10.1542/peds.2015-4271. Epub 2016 Jan 25.
Snyers D, Tribolet S, Rigo V. Intranasal Analgosedation for Infants in the Neonatal Intensive Care Unit: A Systematic Review. Neonatology. 2022;119(3):273-284. doi: 10.1159/000521949. Epub 2022 Mar 1.
Pasero C. Pain assessment in infants and young children: Premature Infant Pain Profile. Am J Nurs. 2002 Sep;102(9):105-6. doi: 10.1097/00000446-200209000-00065. No abstract available.
Francis K. What Is Best Practice for Providing Pain Relief During Retinopathy of Prematurity Eye Examinations? Adv Neonatal Care. 2016 Jun;16(3):220-8. doi: 10.1097/ANC.0000000000000267.
Ballantyne M, Stevens B, McAllister M, Dionne K, Jack A. Validation of the premature infant pain profile in the clinical setting. Clin J Pain. 1999 Dec;15(4):297-303. doi: 10.1097/00002508-199912000-00006.
Brummelte S, Grunau RE, Chau V, Poskitt KJ, Brant R, Vinall J, Gover A, Synnes AR, Miller SP. Procedural pain and brain development in premature newborns. Ann Neurol. 2012 Mar;71(3):385-96. doi: 10.1002/ana.22267. Epub 2012 Feb 28.
Mitchell AJ, Green A, Jeffs DA, Roberson PK. Physiologic effects of retinopathy of prematurity screening examinations. Adv Neonatal Care. 2011 Aug;11(4):291-7. doi: 10.1097/ANC.0b013e318225a332.
Moral-Pumarega MT, Caserio-Carbonero S, De-La-Cruz-Bertolo J, Tejada-Palacios P, Lora-Pablos D, Pallas-Alonso CR. Pain and stress assessment after retinopathy of prematurity screening examination: indirect ophthalmoscopy versus digital retinal imaging. BMC Pediatr. 2012 Aug 28;12:132. doi: 10.1186/1471-2431-12-132.
Thirunavukarasu AJ, Hassan R, Savant SV, Hamilton DL. Analgesia for retinopathy of prematurity screening: A systematic review. Pain Pract. 2022 Sep;22(7):642-651. doi: 10.1111/papr.13138. Epub 2022 Jun 27.
Slevin M, Murphy JF, Daly L, O'Keefe M. Retinopathy of prematurity screening, stress related responses, the role of nesting. Br J Ophthalmol. 1997 Sep;81(9):762-4. doi: 10.1136/bjo.81.9.762.
Other Identifiers
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98/2024
Identifier Type: -
Identifier Source: org_study_id
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