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Dexmedetomidine for LISA Procedure in Preterm Infants (DEXLISA)

Primary Purpose

RDS

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RDS focused on measuring RDS, LISA, preterm, sedation, dexmedetomidine

Eligibility Criteria

26 Weeks - 36 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Need for emergency intubation in the delivery room
  2. Major congenital malformations (such as cardiopathies)
  3. Chromosomic abnormalities
  4. Fetal Hydrops
  5. Hypercapnia: CO2 > 65 mmHg
  6. Pneumothorax
  7. Hemodynamic compromise

Sites / Locations

  • Paola Lago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Every preterm newborns 26+0 -36+6 wGA with RDS needing surfactant therapy

Arm Description

Every 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.

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

number of laryngoscopies needed to perform LISA
calculate the number of laryngoscopies needed to perform LISA
time needed to perform LISA
calculate the time needed to perform LISA
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)
the evolution of cardiorespiratory parameters
heart rate (beats per minute)
the evolution of cardiorespiratory parameters
respiratory rate (breaths per minute)
the evolution of cardiorespiratory parameters
pulse oximetry (%)
the evolution of cardiorespiratory parameters
blood pressure (mmHg)
the evolution of cardiorespiratory parameters
FiO2 maxima during the procedure maintained for at least 30 seconds (%)
changes in ventilation mode
inspiratory and end-expiratory ventilation pressures changes (cmH2O)
The incidence of drug adverse effects
respiratory events (i.e. bronchospasm) or cardiovascular events (bradycardia, hypotension)
The incidence of pneumothorax or selective administration of surfactant
RX evaluation
Long term outcomes
mortality (%)
Long term outcomes
bronchopulmonary dysplasia (%), defined as oxygen administration and/or respiratory support at 36 wGA
Long term outcomes
intraventricular hemorrhage (%) and periventricular leukomalacia (%)
Long term outcomes
necrotizing enterocolitis (%)
Long term outcomes
retinopathy of prematurity (%)

Full Information

First Posted
March 19, 2021
Last Updated
April 27, 2021
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT04820101
Brief Title
Dexmedetomidine for LISA Procedure in Preterm Infants
Acronym
DEXLISA
Official Title
Dexmedetomidine for LISA Procedure in Preterm Infants: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2021 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RDS
Keywords
RDS, LISA, preterm, sedation, dexmedetomidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Every preterm newborns 26+0 -36+6 wGA with RDS needing surfactant therapy
Arm Type
Experimental
Arm Description
Every 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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
LISA procedure
Intervention Description
administrating dexmedetomidine in order to evaluate the efficacy in achieving sedation for LISA procedure
Primary Outcome Measure Information:
Title
effectiveness of dexmedetomidine in achieving sedation for LISA procedure
Description
evaluation of changes in Neonatal Infant Pain Scale (NIPS) score (0-2 points= no pain, 3-4 points = moderate pain; > 4 = severe pain)
Time Frame
basal (before procedure), during and immediately after the procedure
Title
Safety of dexmedetomidine in sedating preterm infants
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
number of laryngoscopies needed to perform LISA
Description
calculate the number of laryngoscopies needed to perform LISA
Time Frame
during the procedure
Title
time needed to perform LISA
Description
calculate the time needed to perform LISA
Time Frame
during the procedure
Title
Intubation conditions
Description
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)
Time Frame
during the procedure
Title
the evolution of cardiorespiratory parameters
Description
heart rate (beats per minute)
Time Frame
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
Title
the evolution of cardiorespiratory parameters
Description
respiratory rate (breaths per minute)
Time Frame
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
Title
the evolution of cardiorespiratory parameters
Description
pulse oximetry (%)
Time Frame
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
Title
the evolution of cardiorespiratory parameters
Description
blood pressure (mmHg)
Time Frame
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
Title
the evolution of cardiorespiratory parameters
Description
FiO2 maxima during the procedure maintained for at least 30 seconds (%)
Time Frame
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
Title
changes in ventilation mode
Description
inspiratory and end-expiratory ventilation pressures changes (cmH2O)
Time Frame
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
Title
The incidence of drug adverse effects
Description
respiratory events (i.e. bronchospasm) or cardiovascular events (bradycardia, hypotension)
Time Frame
24 hours after drug injection
Title
The incidence of pneumothorax or selective administration of surfactant
Description
RX evaluation
Time Frame
24 hours after drug injection
Title
Long term outcomes
Description
mortality (%)
Time Frame
at 40 weeks PMA
Title
Long term outcomes
Description
bronchopulmonary dysplasia (%), defined as oxygen administration and/or respiratory support at 36 wGA
Time Frame
at 40 weeks PMA
Title
Long term outcomes
Description
intraventricular hemorrhage (%) and periventricular leukomalacia (%)
Time Frame
at 40 weeks PMA
Title
Long term outcomes
Description
necrotizing enterocolitis (%)
Time Frame
at 40 weeks PMA
Title
Long term outcomes
Description
retinopathy of prematurity (%)
Time Frame
at 40 weeks PMA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Lago, MD
Phone
00390422322608
Email
paola.lago@aulss2.veneto.it
First Name & Middle Initial & Last Name or Official Title & Degree
Beatrice Galeazzo, MD
Phone
00390422322608
Email
beatrice.galeazzo@aulss2.veneto.it
Facility Information:
Facility Name
Paola Lago
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatrice c Galeazzo, MD
Phone
00390422322608
Email
beatrice.galeazzo@aulss2.veneto.it
First Name & Middle Initial & Last Name & Degree
Paola Lago, MD
First Name & Middle Initial & Last Name & Degree
Beatrice Galeazzo, MD
First Name & Middle Initial & Last Name & Degree
Nadia Battajon, MD
First Name & Middle Initial & Last Name & Degree
Valentina Favero, MD
First Name & Middle Initial & Last Name & Degree
Silvia Vendramin, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
at the end of the study (April 2023)
IPD Sharing Access Criteria
The investigators will access the data and the statistician
Citations:
PubMed Identifier
20472939
Citation
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. Erratum In: N Engl J Med. 2010 Jun 10;362(23):2235.
Results Reference
background
PubMed Identifier
27976361
Citation
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.
Results Reference
background
PubMed Identifier
24144716
Citation
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.
Results Reference
background
PubMed Identifier
26414549
Citation
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.
Results Reference
background
PubMed Identifier
1509593
Citation
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.
Results Reference
background
PubMed Identifier
27837757
Citation
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.
Results Reference
background
PubMed Identifier
26053341
Citation
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.
Results Reference
background
PubMed Identifier
27532916
Citation
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. Erratum In: JAMA. 2016 Sep 13;316(10):1116.
Results Reference
background
PubMed Identifier
27852668
Citation
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.
Results Reference
background
PubMed Identifier
20176672
Citation
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.
Results Reference
background
PubMed Identifier
26810788
Citation
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.
Results Reference
background
PubMed Identifier
30538147
Citation
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.
Results Reference
background
PubMed Identifier
28483817
Citation
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.
Results Reference
background
PubMed Identifier
26907795
Citation
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.
Results Reference
background
PubMed Identifier
29532502
Citation
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.
Results Reference
background
PubMed Identifier
30068669
Citation
Dekker J, Lopriore E, van Zanten HA, Tan RNGB, Hooper SB, Te Pas AB. Sedation during minimal invasive surfactant therapy: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F378-F383. doi: 10.1136/archdischild-2018-315015. Epub 2018 Aug 1.
Results Reference
background
PubMed Identifier
32384914
Citation
Chevallier M, Durrmeyer X, Ego A, Debillon T; PROLISA Study Group. Propofol versus placebo (with rescue with ketamine) before less invasive surfactant administration: study protocol for a multicenter, double-blind, placebo controlled trial (PROLISA). BMC Pediatr. 2020 May 8;20(1):199. doi: 10.1186/s12887-020-02112-x.
Results Reference
background
PubMed Identifier
28598946
Citation
Venkatraman R, Hungerford JL, Hall MW, Moore-Clingenpeel M, Tobias JD. Dexmedetomidine for Sedation During Noninvasive Ventilation in Pediatric Patients. Pediatr Crit Care Med. 2017 Sep;18(9):831-837. doi: 10.1097/PCC.0000000000001226.
Results Reference
background
PubMed Identifier
28105598
Citation
Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine. Clin Pharmacokinet. 2017 Aug;56(8):893-913. doi: 10.1007/s40262-017-0507-7.
Results Reference
background
PubMed Identifier
8413140
Citation
Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
Results Reference
background
PubMed Identifier
26473001
Citation
Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
Results Reference
background
PubMed Identifier
28654173
Citation
Tran DTT, Newton EK, Mount VAH, Lee JS, Mansour C, Wells GA, Perry JJ. Rocuronium vs. succinylcholine for rapid sequence intubation: a Cochrane systematic review. Anaesthesia. 2017 Jun;72(6):765-777. doi: 10.1111/anae.13903.
Results Reference
background
PubMed Identifier
26628729
Citation
Eichenwald EC; Committee on Fetus and Newborn, American Academy of Pediatrics. Apnea of Prematurity. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-3757. Epub 2015 Dec 1.
Results Reference
background
PubMed Identifier
30974433
Citation
Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
Results Reference
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Dexmedetomidine for LISA Procedure in Preterm Infants

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