Drug SafetyPhase 1NCT06889376
Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
A Phase 1 study testing Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care. in people with Drug Safety, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 30 weeks
- Conditions the study is for
- Drug Safety
- What is being tested?
- Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 24 Mar 2025to 6 Jul 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns qualified for ophthalmologic screening examination to detect retinopathy of prematurity (ROP):
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Polish Mother's Health Center Institute Rzgowska 281/289, 93-338 Lodz
Lodz, 93-338
Agnieszka Nowacka, Lek. med., +48607603226, agnieszka.nowacka@iczmp.edu.pl
Agnieszka Nowacka, Lek. med
About this study
Official title: The Use of Intranasal Sedation With Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening
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.
Read the detailed 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.
- Conditions
- Drug Safety
- Being tested
- Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.
- Keywords
- intranasal midazolam, ROP screening, Premature infants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.Drug
Also called nasal midazolam
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)
| Study group | Role | What they receive |
|---|---|---|
| Intranasal midazolam and comfort care | Experimental | 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 Receives: Drug: Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care. |
| Control group | No intervention | Control Group (non-midazolam group) * No midazolam administered. * Routine comfort care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: PIPP Score Assessment Time Points: 5 minutes before drug administration, during drug administration, 10, 30 minutes 1 hour and 2 hours post-procedure
Secondary outcomes (2)
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.
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start24 Mar 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion6 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polish Mother Memorial Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Nowacka, Polish Mother Memorial Hospital Research Institute
- Investigators
- Ewa Gulczyńska, Professor, Study chair, Polish Mother's Health Center Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889376
- Sponsor's protocol ID
- 98/2024
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37745081Salaets 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.
PubMed 31537552Morgan 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.
PubMed 33009491Vinall 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.
PubMed 22704600COMMITTEE 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.
PubMed 26810788Snyers 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.
PubMed 35231912Pasero 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.
PubMed 12394025Francis 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.
PubMed 27195471Ballantyne 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.
PubMed 10617258Brummelte 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.
PubMed 22374882Mitchell 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.
PubMed 22123352Moral-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.
PubMed 22928523Thirunavukarasu 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.
PubMed 35703418Slevin 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.
PubMed 9422929
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intranasal Sedation With Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening
- ClinicalTrials.gov ID
- NCT06889376
- Acronym / sponsor ID
- 98/2024
- Conditions
- Drug Safety
- Keywords
- intranasal midazolam, ROP screening, Premature infants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
- Study start
- 24 Mar 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 6 Jul 2025 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal midazolam and comfort care | Experimental | Drug: Intranasal midazolam administration via the DART™ intranasal atomization device along with routine 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 |
| Control group | No intervention | –Control Group (non-midazolam group) * No midazolam administered. * Routine comfort care |
Who may qualify
- Ages
- Up to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns qualified for ophthalmologic screening examination to detect retinopathy of prematurity (ROP):
- Obtaining informed consent from a parent/legal guardian.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.Also: nasal midazolamIntervention: 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) | Drug | Intranasal midazolam and comfort care |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 37745081Salaets 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.
- Background: PubMed 31537552Salaets 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.
- Background: PubMed 33009491Morgan 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.
- Background: PubMed 22704600Vinall 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.
- Background: PubMed 26810788COMMITTEE 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.
- Background: PubMed 35231912Snyers 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.
- Background: PubMed 12394025Pasero 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.
- Background: PubMed 27195471Francis 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.
- Background: PubMed 10617258Ballantyne 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.
- Background: PubMed 22374882Brummelte 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.
- Background: PubMed 22123352Mitchell 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.
- Background: PubMed 22928523Moral-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ewa Gulczyńska, Professor study chair
Polish Mother's Health Center Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care. in people with Drug Safety, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka Nowacka, MSc (+48 607603226, agn.nowacka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06889376, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.