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RDSDEXLISANCT04820101

Dexmedetomidine for LISA Procedure in Preterm Infants

A study testing Dexmedetomidine in people with RDS, run by University of Padova at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators aim to evaluate: the effectiveness of dexmedetomidine for analgesia and sedation during LISA procedure, without compromising the respiratory drive; the safety of this drug on the preterm infant in a pilot study. Read more about this study

Who is it for?
Ages 26 to 36 weeksHealthy volunteers can take part
Conditions the study is for
RDS
What is being tested?
Dexmedetomidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
15 May 2021to 1 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

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 26 to 36 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Preterm newborns between 26+0 and 36+6 weeks of gestation stratified in two groups: VLBWI 26-31+6and LBWI 32-36+6.
  • Respiratory distress syndrome requiring surfactant therapy

Who cannot join

  • Need for emergency intubation in the delivery room
  • Major congenital malformations (such as cardiopathies)
  • Chromosomic abnormalities
  • Fetal Hydrops
  • Hypercapnia: CO2 > 65 mmHg
  • Pneumothorax
  • Hemodynamic compromise

Trial locations and contacts

1 site in 1 country.

Paola Lago, MD contact

00390422322608

paola.lago@aulss2.veneto.it

Beatrice Galeazzo, MD contact

00390422322608

beatrice.galeazzo@aulss2.veneto.it

Italy1 site

  • Paola Lago

    Treviso, 31100

    Beatrice c Galeazzo, MD, 00390422322608, beatrice.galeazzo@aulss2.veneto.it

    Paola Lago, MD

Other trials in Italy

About this study

Official title: Dexmedetomidine for LISA Procedure in Preterm Infants: a Pilot Study

The investigators aim to evaluate: the effectiveness of dexmedetomidine for analgesia and sedation during LISA procedure, without compromising the respiratory drive; the safety of this drug on the preterm infant in a pilot study.

Read the detailed description

Information will be given to parents of preterm babies <36 wGA upon their admission to the NICU (neonatal intensive care unit), and informed consent will be obtained as soon as possible. Eligible babies for LISA procedure (dyspneic and FiO2 > 0.30 on CPAP pressure of at least 6 cmH2O) undergo sedation with dexmedetomidine 1 mcg/kg, administered slowly iv in 10 minutes, together with non pharmacological techniques. After the step of sedation LISA is performed. Before/during and after the procedure pain will be assessed by the NIPS scale and the quality of intubation will be evaluated; then other events related to the procedure will be strictly collected for the first 24 hours. Babies will then be managed in usual NICU way and clinical data will be unregistered on respiratory, neurological and hemodynamic outcomes during the hospital stay, and especially at discharge.

Conditions
RDS
Being tested
Dexmedetomidine
Keywords
RDS, LISA, preterm, sedation, dexmedetomidine
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called LISA procedure

    administrating dexmedetomidine in order to evaluate the efficacy in achieving sedation for LISA procedure

Study groups in NCT04820101
Study groupRoleWhat they receive
Every preterm newborns 26+0 -36+6 wGA with RDS needing surfactant therapyExperimentalEvery preterm newborns 26+0-36+6 wGA who undergoes LISA procedure will receive sedation with dexmedetomidine in order to evaluate its efficacy in achieving pain control and comfort.
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. effectiveness of dexmedetomidine in achieving sedation for LISA procedure

    evaluation of changes in Neonatal Infant Pain Scale (NIPS) score (0-2 points= no pain, 3-4 points = moderate pain; > 4 = severe pain)

    Measured: basal (before procedure), during and immediately after the procedure

  2. Safety of dexmedetomidine in sedating preterm infants

    evaluation of number of apneas ( > 20 seconds or < 20 seconds with bradycardia < 100 bpm or desaturation ( SpO2 < 85%)); number of severe apnea and bradycardia (defined by the American Academy of Pediatrics Guidelines as apnea > 30 seconds and/or heart rate < 60 beats/minute for more than 10 seconds); need for intubation.

    Measured: 24 hours

Secondary outcomes (16)

  1. number of laryngoscopies needed to perform LISA

    calculate the number of laryngoscopies needed to perform LISA

    Measured: during the procedure

  2. time needed to perform LISA

    calculate the time needed to perform LISA

    Measured: during the procedure

  3. Intubation conditions

    evaluated by the operator using the Goldberg scale (3 = excellent intubation conditions; 4-6= good intubation conditions; 7-9 = poor intubation conditions; 10-12 = inadequate intubation conditions)

    Measured: during the procedure

  4. the evolution of cardiorespiratory parameters

    heart rate (beats per minute)

    Measured: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection

  5. the evolution of cardiorespiratory parameters

    respiratory rate (breaths per minute)

    Measured: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection

  6. the evolution of cardiorespiratory parameters

    pulse oximetry (%)

    Measured: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection

  7. the evolution of cardiorespiratory parameters

    blood pressure (mmHg)

    Measured: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection

  8. the evolution of cardiorespiratory parameters

    FiO2 maxima during the procedure maintained for at least 30 seconds (%)

    Measured: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection

  9. changes in ventilation mode

    inspiratory and end-expiratory ventilation pressures changes (cmH2O)

    Measured: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection

  10. The incidence of drug adverse effects

    respiratory events (i.e. bronchospasm) or cardiovascular events (bradycardia, hypotension)

    Measured: 24 hours after drug injection

  11. The incidence of pneumothorax or selective administration of surfactant

    RX evaluation

    Measured: 24 hours after drug injection

  12. Long term outcomes

    mortality (%)

    Measured: at 40 weeks PMA

  13. Long term outcomes

    bronchopulmonary dysplasia (%), defined as oxygen administration and/or respiratory support at 36 wGA

    Measured: at 40 weeks PMA

  14. Long term outcomes

    intraventricular hemorrhage (%) and periventricular leukomalacia (%)

    Measured: at 40 weeks PMA

  15. Long term outcomes

    necrotizing enterocolitis (%)

    Measured: at 40 weeks PMA

  16. Long term outcomes

    retinopathy of prematurity (%)

    Measured: at 40 weeks PMA

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start15 May 2021 (estimated)
  3. Primary completion1 Apr 2023 (estimated)
  4. Study completion1 Apr 2023 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04820101
Sponsor's protocol ID
DEXLISA 920/CE Marca
Acronym
DEXLISA
Status last verified
Apr 2021
First submitted
19 Mar 2021
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all collected IPD, all IPD that underlie results in a publication

Publications

  • SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Donovan EF, Newman NS, Ambalavanan N, Frantz ID 3rd, Buchter S, Sanchez PJ, Kennedy KA, Laroia N, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Bhandari V, Watterberg KL, Higgins RD. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1970-9. doi: 10.1056/NEJMoa0911783. Epub 2010 May 16.

    PubMed 20472939

  • Lemyre B, Laughon M, Bose C, Davis PG. Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants. Cochrane Database Syst Rev. 2016 Dec 15;12(12):CD005384. doi: 10.1002/14651858.CD005384.pub2.

    PubMed 27976361

  • Fischer HS, Buhrer C. Avoiding endotracheal ventilation to prevent bronchopulmonary dysplasia: a meta-analysis. Pediatrics. 2013 Nov;132(5):e1351-60. doi: 10.1542/peds.2013-1880. Epub 2013 Oct 21.

    PubMed 24144716

  • Jensen EA, DeMauro SB, Kornhauser M, Aghai ZH, Greenspan JS, Dysart KC. Effects of Multiple Ventilation Courses and Duration of Mechanical Ventilation on Respiratory Outcomes in Extremely Low-Birth-Weight Infants. JAMA Pediatr. 2015 Nov;169(11):1011-7. doi: 10.1001/jamapediatrics.2015.2401.

    PubMed 26414549

  • Verder H, Agertoft L, Albertsen P, Christensen NC, Curstedt T, Ebbesen F, Greisen G, Hobolth N, Holm V, Jacobsen T, et al. [Surfactant treatment of newborn infants with respiratory distress syndrome primarily treated with nasal continuous positive air pressure. A pilot study]. Ugeskr Laeger. 1992 Jul 27;154(31):2136-9. Danish.

    PubMed 1509593

  • Kribs A. Minimally Invasive Surfactant Therapy and Noninvasive Respiratory Support. Clin Perinatol. 2016 Dec;43(4):755-771. doi: 10.1016/j.clp.2016.07.010. Epub 2016 Oct 14.

    PubMed 27837757

  • Kribs A, Roll C, Gopel W, Wieg C, Groneck P, Laux R, Teig N, Hoehn T, Bohm W, Welzing L, Vochem M, Hoppenz M, Buhrer C, Mehler K, Stutzer H, Franklin J, Stohr A, Herting E, Roth B; NINSAPP Trial Investigators. Nonintubated Surfactant Application vs Conventional Therapy in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2015 Aug;169(8):723-30. doi: 10.1001/jamapediatrics.2015.0504.

    PubMed 26053341

  • Isayama T, Iwami H, McDonald S, Beyene J. Association of Noninvasive Ventilation Strategies With Mortality and Bronchopulmonary Dysplasia Among Preterm Infants: A Systematic Review and Meta-analysis. JAMA. 2016 Aug 9;316(6):611-24. doi: 10.1001/jama.2016.10708.

    PubMed 27532916

  • Aldana-Aguirre JC, Pinto M, Featherstone RM, Kumar M. Less invasive surfactant administration versus intubation for surfactant delivery in preterm infants with respiratory distress syndrome: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102(1):F17-F23. doi: 10.1136/archdischild-2015-310299. Epub 2016 Nov 15.

    PubMed 27852668

  • Kumar P, Denson SE, Mancuso TJ; Committee on Fetus and Newborn, Section on Anesthesiology and Pain Medicine. Premedication for nonemergency endotracheal intubation in the neonate. Pediatrics. 2010 Mar;125(3):608-15. doi: 10.1542/peds.2009-2863. Epub 2010 Feb 22.

    PubMed 20176672

  • 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.

    PubMed 26810788

  • Foglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, Quek BH, Johnston LC, Barry J, Zenge J, Moussa A, Kim JH, DeMeo SD, Napolitano N, Nadkarni V, Nishisaki A; NEAR4NEOS Investigators. Neonatal Intubation Practice and Outcomes: An International Registry Study. Pediatrics. 2019 Jan;143(1):e20180902. doi: 10.1542/peds.2018-0902. Epub 2018 Dec 11.

    PubMed 30538147

  • Descamps CS, Chevallier M, Ego A, Pin I, Epiard C, Debillon T. Propofol for sedation during less invasive surfactant administration in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2017 Sep;102(5):F465. doi: 10.1136/archdischild-2017-312791. Epub 2017 May 8. No abstract available.

    PubMed 28483817

  • Dekker J, Lopriore E, Rijken M, Rijntjes-Jacobs E, Smits-Wintjens V, Te Pas A. Sedation during Minimal Invasive Surfactant Therapy in Preterm Infants. Neonatology. 2016;109(4):308-13. doi: 10.1159/000443823. Epub 2016 Feb 24.

    PubMed 26907795

  • Bourgoin L, Caeymaex L, Decobert F, Jung C, Danan C, Durrmeyer X. Administering atropine and ketamine before less invasive surfactant administration resulted in low pain scores in a prospective study of premature neonates. Acta Paediatr. 2018 Jul;107(7):1184-1190. doi: 10.1111/apa.14317. Epub 2018 Apr 16.

    PubMed 29532502

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine in people with RDS, run by University of Padova at 1 site in Italy.

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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Apr 2021. 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 Italy. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paola Lago, MD (00390422322608, paola.lago@aulss2.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effectiveness of dexmedetomidine in achieving sedation for LISA procedure (time frame: basal (before procedure), during and immediately after the procedure). The study lists 2 primary outcomes in all. 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 NCT04820101, which also lists 25 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 29 Apr 2021.

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