Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates With Respiratory Distress Syndrome

Karolinska Institute

Status: Completed

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Device: Surfactant Administration Through Laryngeal or Supraglottic Airways

Study type: Interventional

Funder types: Other

Identifiers

NCT06606444

2018-02770 (Other Identifier)

2090 CN/PS

Details and patient eligibility

About

Surfactant administration via a supraglottic airway device or laryngeal mask airway (SALSA) is a minimally invasive method of instilling surfactant in the trachea during spontaneous breathing and after applying nasal continuous positive airway pressure (nCPAP). However, the procedure has been limited from use in very low birth weight neonates, due to lack of preterm size LMAs, which are now emerging on the market.

The goal of this study is to see if investigators can successfully use a new, smaller laryngeal mask airway (LMA) to place and give surfactant to premature babies with respiratory distress syndrome (RDS) who weigh between 750g and 1500g at birth.

The main objectives of the study are to:

• Check the placement of the new, smaller LMA: This includes evaluating the airway, how long it takes to place the LMA, how many attempts are needed, and the baby's stability during the process.
• Evaluate the administration of surfactant using the new LMA: Investigators will look at how the baby responds clinically, any changes in oxygen needs, how many doses of surfactant are required, the level of respiratory support needed, and whether intubation or mechanical ventilation is necessary.
• Ensure the safety of using the new LMA and administering surfactant: Investigators will monitor the baby's stability during the procedure and watch for any adverse events.
• Assess pain during the procedure: Investigators will evaluate pain levels using a pain scale based on video reviews.

Above objectives of feasibility are to be assessed before proceeding to a large randomize clinical trial assessing effectiveness and safety.

Full description

Methodology Feasibility will be measure by a combination of real-life observations of the procedure and video-review with synced physiological data (oxygen saturation and heart rate).

Study Site The Phu San Hanoi Hospital, the largest obstetric hospital in northern Vietnam, receives about 40.000 births annually and has a level-III neonatal intensive care unit with capacity of approximately 40 neonates. Approximately 10-15 neonates weighing less than 1500g per month are admitted who receives standard surfactant treatment with IN-tubation-SURfactant-Extubation (INSURE).

Enrollment: 45 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parental informed consent, AND
• Inborn neonate (=born in the hospital), AND
• Gestational age less than 34 + 0 weeks, AND
• Age less than 48 hours, AND
• Birth weight from 750g to 1500g, AND
• Clinical diagnosis of RDS requiring non-invasive respiratory support (CPAP/NIPPV) and fraction of inspired oxygen (FiO2) 0.30-0.60 to maintain oxygen saturation (SpO2) between 90% and 95%.

Exclusion criteria

• Severe respiratory insufficiency in need of emergency intubation
• Previous surfactant administration
• Previous mechanical ventilation
• Known pneumothorax
• Major malformations
• Investigators not available

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Surfactant administered via laryngeal mask airway

Experimental group

Description:

Enrolled infants will receive surfactant delivered via a neonatal size laryngeal mask airway.

Treatment:

Device: Surfactant Administration Through Laryngeal or Supraglottic Airways