Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-72
SponsorUniversity of Texas Southwestern Medical Center

About this trial

What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube ("Less Invasive Surfactant Administration", called the LISA method) or through a small airway device placed in the baby's throat ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for infants who are born at or after 29 weeks of pregnancy and have trouble breathing.

What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer breathing-related problems and fewer short-term complications than those who receive it using the LISA method.

What are the aims? Aim 1: Are babies in the SALSA group less likely to have low heart rate or low oxygen levels during the procedure compared to babies in the LISA group? Aim 2: Do fewer babies in the SALSA group need to be put on a breathing machine within the first 72 hours of life? Aim 3: Does the SALSA method help reduce the overall time babies need breathing support and lower the cost of their care in the NICU?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All preterm infants born at or greater than 29 weeks' gestational age

Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support and qualify for LISA procedure

Disqualifiers

Infants who require intubation prior to surfactant therapy

Infants with known severe congenital anomalies (complex congenital heart disease, airway and central nervous system anomalies)

Infants whose birth weight is less than 750 grams or oropharynx unable to accommodate laryngeal mask airways

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surfactant Administration through Laryngeal or Supraglottic Airway

    Procedure/Surgery

    Surfactant Administration through Supraglottic Airway Devices * Air-Q3 size 0 for neonates: \< 2 kilograms * i-gel supraglottic airway size 1 for neonates: ≥ 2 kilograms

  • Surfactant Administration through Thin Catheter

    Procedure/Surgery

    Thin Catheter

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Surfactant Administration through Laryngeal or Supraglottic AirwayExperimental treatment 1 intervention
Group B: Surfactant Administration through Thin CatheterActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of events of bradycardia and hypoxemia during surfactant administration

* Bradycardia: defined as heart rate \< 100 beats per minute for \> 10 seconds. Heart rate will be obtained from participant's heart rate monitor. * Hypoxemia: oxygen saturation (SpO2) =\< 80% for \> 30 seconds. Oxygen saturation will be obtained from participant's pulse oximeter monitor * Events will be recorded by bedside respiratory therapy and/or bedside nurse during the procedure

Time frame
Time of surfactant administration to completion of procedure

Secondary outcomes

1

Procedural success rate on first attempt

* Procedure attempt is defined at the introduction of laryngoscope blade into mouth. * Procedural success is defined by the ability to insert catheter or laryngeal mask airway and administer surfactant without surfactant aspirated from the stomach post administration * Rate will be calculated as a percentage of participants in each arm

Time frame
At time of surfactant administration procedure
2

Intubation rate

* Rate will be calculated as a percentage of participants in each arm Invasive mechanical ventilation within first 72 hours of life after surfactant * Participants' need for and timing of intubation will be obtained from electronic medical record

Time frame
From time of procedure to 72 hours of life
3

Mean number of attempts required

Procedure attempt will be defined as introduction of laryngoscope blade into mouth.

Time frame
At time of surfactant administration
4

Total duration of CPAP and mechanical ventilation days

Total numbers of days on continuous end positive expiratory pressure (CPAP) and invasive mechanical ventilation

Time frame
Up to 52 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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