UnknownPhase 1ketamine

The Use of Sedation Drugs in the Procedure of Administering Surfactant Without Intubation (LISA/MIST)

NCT ID

NCT04409665

Target Enrollment

60 participants

Start Date

2020-01-01

Est. Completion

2022-04-30

About This Study

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.

Conditions Studied

Neonatal Respiratory Distress SyndromeGestational Age Conditions

Interventions

•Ketamine
•Glucose

Eligibility

Age:1 Minute - 4 Months

Healthy Volunteers:No

View full eligibility criteria

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

Study Locations (1)

Uniwersyteckie Centrum Zdrowia Kobiety Noworodka

Warsaw, Masovian Voivodeship, Poland