Neonatal Respiratory Distress Syndrome Clinical Trial
— LISA KGSOfficial title:
The Use of Sedation Drugs in the Procedure of Administering Surfactant Without Intubation (LISA/MIST): a Randomized Study Comparing Intravenous Ketamine With Sublingual 30% Glucose
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 30, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Uniwersyteckie Centrum Zdrowia Kobiety Noworodka | Warsaw | Mazowieckie |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
Allegaert K, van den Anker JN. Neonatal pain management: still in search for the Holy Grail. Int J Clin Pharmacol Ther. 2016 Jul;54(7):514-23. doi: 10.5414/CP202561. Review. — View Citation
Barrington K. Premedication for endotracheal intubation in the newborn infant. Paediatr Child Health. 2011 Mar;16(3):159-71. English, French. — View 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. — View 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. — View Citation
Fernandez C, Boix H, Camba F, Comuñas JJ, Castillo F. Less Invasive Surfactant Administration in Spain: A Survey Regarding Its Practice, the Target Population, and Premedication Use. Am J Perinatol. 2020 Feb;37(3):277-280. doi: 10.1055/s-0039-1678534. Epub 2019 Feb 4. — View Citation
Kurepa D, Perveen S, Lipener Y, Kakkilaya V. The use of less invasive surfactant administration (LISA) in the United States with review of the literature. J Perinatol. 2019 Mar;39(3):426-432. doi: 10.1038/s41372-018-0302-9. Epub 2019 Jan 11. Review. — View Citation
McPherson C, Grunau RE. Neonatal pain control and neurologic effects of anesthetics and sedatives in preterm infants. Clin Perinatol. 2014 Mar;41(1):209-27. doi: 10.1016/j.clp.2013.10.002. Epub 2013 Dec 17. Review. — View Citation
McPherson C, Inder T. Perinatal and neonatal use of sedation and analgesia. Semin Fetal Neonatal Med. 2017 Oct;22(5):314-320. doi: 10.1016/j.siny.2017.07.007. Epub 2017 Jul 19. Review. — View Citation
Milesi C, Cambonie G, Jacquot A, Barbotte E, Mesnage R, Masson F, Pidoux O, Ferragu F, Thevenot P, Mariette JB, Picaud JC. Validation of a neonatal pain scale adapted to the new practices in caring for preterm newborns. Arch Dis Child Fetal Neonatal Ed. 2010 Jul;95(4):F263-6. doi: 10.1136/adc.2008.144758. Epub 2009 Feb 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of patient sedation | Assessment of patient sedation change before and after LISA using COMFORT scale | First assessment 10 minutes before procedure, second during the procedure | |
Primary | Assessment of patient sedation | Assessment of patient sedation change before and after LISA using FANS scale | First assessment 10 minutes before procedure, second during the procedure | |
Primary | Comparing ketamine and glucose | 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. | Comparing the scores through study completion, an average of two years | |
Primary | Comparing ketamine and glucose | Comparison of the effectiveness of sedation with ketamine and glucose using the COMFORT scale scores. The Comfort scale ranges from 8 points at minimum, to 40 at maximum. The higher the score, the lower the sedation level. | Comparing the scores through study completion, an average of two years | |
Secondary | Frequency of complications | Monitoring the possible side effects of used drugs | During the procedure |
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