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
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
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.
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
- PIPP SCALE score [ Time Frame: during the LISA procedure ]Verify which is the best premedication for LISA procedure to reduce neonatal pain.
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
|NICU "V. Buzzi" Children's Hospital||Not yet recruiting|
|Milan, Italy, 20154|
|Contact: ILIA BRESESTI, MD|
|Principal Investigator: ILIA BRESESTI, MD|