Overview

Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome

Status:
Unknown status

Trial end date:
2020-03-01

Target enrollment:
0

Participant gender:
All

Summary

In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway (inserted after pre-medication for pain with a short-acting narcotic), or to surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and return babies to non-invasive CPAP support, after surfactant is given. The primary outcome measure is the rate of failure of initial surfactant therapy. Standardized failure criteria are reached: a) early, if the baby is unable to be placed back on non-invasive CPAP (i.e., needs tracheal intubation and mechanical ventilation) or, b) late, if the baby requires ventilation, retreatment with surfactant within 8 hours or more than 2 doses of surfactant. The objective of this protocol is to reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by instilling surfactant though an LMA, while achieving comparable efficacy of surfactant treatment. The hypothesis is that surfactant treatment through an LMA will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation, when compared to standard surfactant treatment following endotracheal intubation with sedation.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Albany Medical College

Collaborators:

ONY
University of Rochester

Treatments:

Remifentanil

Criteria

Inclusion Criteria:

- Mild-to-moderate RDS;

- Postnatal age 2 to 48 hours;

- Gestational age 27 0/7 to 36 6/7 weeks;

- Treated with nasal CPAP modalities ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at
least 2 hours to maintain SpO2 90-95%;

- Informed consent

Exclusion Criteria:

- Weight < 800 g;

- Airway anomalies;

- Pulmonary air leaks;

- Craniofacial or cardiothoracic malformations