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Study on the Effects of Different Premedication for LISA on Stress and Cerebral Tissue Oxygenation in Preterm Infants (SAFE LISA)

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ClinicalTrials.gov Identifier: NCT03718507
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Gianluca Lista
Information provided by (Responsible Party):
Dr. Ilia Bresesti, ASST Fatebenefratelli Sacco

Brief Summary:

Given the popularity that LISA technique has gainig in worldwide neonatal units, the lack of evidence regarding its premedication is becoming even more relevant to provide the best care to premature infants.

Objective of this clinical trial is to establish the best premedication for LISA procedure considering neonatal pain assessed with premature infants pain scale, salivary cortisol levels as an indicator of stress and crSO2 values as indicators of cerebral oxygenation. Moreover, we aim to verify if sucrose 24% given orally is an effective tool for pain management in preterm neonates also in more invasive procedure, comparable to pharmacological treatment.


Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Surfactant Deficiency Syndrome Neonatal Near Infrared Spectroscopy Drug: Fentanyl Drug: Sucrose 24% Oral Solution Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Single-centre, Randomized Pilot Study on the Effects of Different Premedication Treatments for Less Invasive Surfactant Administration (LISA) on Pain, Cerebral Tissue Oxygenation and Cortisol Levels in Preterm Infants
Estimated Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : February 20, 2020


Arm Intervention/treatment
Active Comparator: GROUP 1
patients will receive atropine (0.01-0.02 mg/kg i.v. bolus) and fentanyl (0.5-2 mcg/kg i.v. in 5 minutes) before LISA in addition to standard care (wrapping). NIRS will be monitored during the whole procedure, which will be video-recorded.
Drug: Fentanyl
atropine (0.01-0.02 mg/kg i.v. bolus) and fentanyl (0.5-2 mcg/kg i.v. in 5 minutes)
Other Name: atropine

Experimental: GROUP 2
patients will be given atropine (0.01-0.02 mg/kg i.v. bolus) and oral sucrose 24% (0.5 ml) 2 minutes before LISA in addition to standard care (wrapping). NIRS will be monitored during the whole procedure, which will be video-recorded.
Drug: Sucrose 24% Oral Solution
0.5 ml given orally 2 minutes before LISA procedure
Other Name: atropine




Primary Outcome Measures :
  1. PIPP SCALE score [ Time Frame: during the LISA procedure ]
    Verify which is the best premedication for LISA procedure to reduce neonatal pain.



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Ages Eligible for Study:   27 Weeks to 29 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm neonate 27-29+6 weeks AND
  • Need for non-invasive respiratory support (CPAP or nHFT) AND
  • Need for surfactant according to the unit guidelines AND
  • Written informed consent

Exclusion Criteria:

  • No written informed consent and/or
  • Severe malformation of the upper/lower airways, brain and/or heart and/or lung and/or prenatal cerebral injury.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718507


Locations
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Italy
NICU "V. Buzzi" Children's Hospital Not yet recruiting
Milan, Italy, 20154
Contact: ILIA BRESESTI, MD         
Principal Investigator: ILIA BRESESTI, MD         
Sponsors and Collaborators
ASST Fatebenefratelli Sacco
Gianluca Lista

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Responsible Party: Dr. Ilia Bresesti, MD, ASST Fatebenefratelli Sacco
ClinicalTrials.gov Identifier: NCT03718507     History of Changes
Other Study ID Numbers: SL2018PS
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Fentanyl
Atropine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics