Gestational Age Conditions, Neonatal Respiratory Distress Syndrome
Conditions
Keywords
LISA, LISA sedation, MIST, MIST sedation, Ketamine, Glucose, RDS, Newborn
Brief summary
The purpose of this study is to evaluate the efficacy and impact of intravenous ketamine or sublingual 30% glucose as sedation drugs used in preterm premature babies during the LISA procedure. The second goal is to compare the frequency of complications during LISA with both premedication regimens.
Detailed description
All infants fulfilling the inclusion criteria during the 12 months recruitment window will potentially be enrolled in this randomized controlled trial of LISA premedication. Written informed consent will be acquired from parents or legal guardians. After the consent, infants needing the LISA will receive premedication as follows: caffeine citrate according to the clinical routine at study site, and randomly, either ketamine or sublingual glucose 30%. This study is a pilot study and 60 patients that will be randomized 1:1. Ketamine will be given in slow intravenous injection over 60 seconds. Glucose 30% will be given sublingually in the volume of 1 mL. After two minutes (from the end of administration of the study drug or reference drug), laryngoscopy will be started. To assess the effectiveness of both types of sedation, patients will be assessed using two pain assessment scales - the COMFORT scale and the FANS scale. 10 minutes before the procedure, the first assessment in the COMFORT and FANS scales will take place. The next assessment on both scales will take place during the procedure.
Interventions
DRUGKetamine
Patient will be sedated using Ketamine 2 minutes before the LISA procedure. 10 minutes prior the procedure and during the procedure the patient's pain and/or discomfort will be evaluated using COMFORT and FANS scales
DRUGGlucose
Patient will be sedated using Glucose 2 minutes before the LISA procedure. 10 minutes prior the procedure and during the procedure the patient's pain and/or discomfort will be evaluated using COMFORT and FANS scales
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
60 infants randomized 1:1 to receive ketamine or glucose
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 4 Months
Healthy volunteers
No
Inclusion criteria
* Infant with established Respiratory Distress Syndrome (RDS) or at risk for RDS * Gestational age 28 0/7 - 32 6/7 weeks * Non-invasive respiratory support with nasal CPAP (incl. BiPAP) or NIPPV * Need for administration of exogenous surfactant
Exclusion criteria
* Need for intubation and mechanical ventilation at the Delivery Room * Infant with clinically significant maxillo-facial, tracheal or pulmonary malformations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of patient sedation | First assessment 10 minutes before procedure, second during the procedure | Assessment of patient sedation change before and after LISA using COMFORT scale |
| Comparing ketamine and glucose | Comparing the scores through study completion, an average of two years | Comparison of the effectiveness of sedation with ketamine and glucose using the FANS scale scores. The FANS scale ranges from 0 points at minimum to 10 points at maximum. The higher the score, the lower the sedation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of complications | During the procedure | Monitoring the possible side effects of used drugs |
Countries
Poland
Contacts
Primary ContactTomasz Piotr Pomianek, MD
Backup ContactPaweł Krajewski, MD, PhD
Outcome results
None listed