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

NCT02164734 | Terminated Phase 4 Results DMC

• 1 other identifier: 3768
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

surfactant

Outcome Measures

Primary Outcomes (1)

• Number of Participants Failing to Avoid Invasive Mechanical Ventilation

  Failure of surfactant therapy in avoiding invasive mechanical ventilation or clinically equivalent outcomes (FiO2 \> 0.60 to maintain target SpO2, second dose of surfactant within 8 hours, or more than 2 total doses of surfactant)

  120 hours

Secondary Outcomes (6)

• Number of Surfactant Doses

  120 hours

• Days on Any Respiratory Support

  3 months

• Rate of Pneumothorax

  120 hours

• Rate of Bronchopulmonary Dysplasia (O2 Dependence at the Later of 28 Days of Age or 36 Weeks Postmenstrual Age)

  3 months

• Number of Participants With Complications During Insertion of LMA or Endotracheal Tube

  120 hours

Other Outcomes (1)

• Number of Participants With Early Failure of Surfactant Therapy

  1 hour

Study Arms (2)

Endotracheal intubation

ACTIVE COMPARATOR

Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication

Device: Endotracheal intubation; Drug: remifentanil

Laryngeal mask airway

EXPERIMENTAL

Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication

Device: Laryngeal mask airway

Interventions

Endotracheal intubation DEVICE

Also known as: INSURE

Endotracheal intubation

Laryngeal mask airway DEVICE

Also known as: LMA North America

Laryngeal mask airway

remifentanil DRUG

additional premedication in the endotracheal intubation/INSURE arm

Endotracheal intubation

Eligibility Criteria

• Age: 2 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Weight \< 800 g;
• Airway anomalies;
• Pulmonary air leaks;
• Craniofacial or cardiothoracic malformations

Sponsors & Collaborators

• Albany Medical College: lead
• University of Rochester: collaborator
• ONY: collaborator

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

Related Publications (1)

• Gallup JA, Ndakor SM, Pezzano C, Pinheiro JMB. Randomized Trial of Surfactant Therapy via Laryngeal Mask Airway Versus Brief Tracheal Intubation in Neonates Born Preterm. J Pediatr. 2023 Mar;254:17-24.e2. doi: 10.1016/j.jpeds.2022.10.009. Epub 2022 Oct 12.

  PMID: 36241051 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Intubation, Intratracheal; Laryngeal Masks; Remifentanil

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The trial was terminated before the target enrollment numbers were reached, due to slow recruitment, which became impossible soon after the onset of the COVID-19 pandemic.

Results Point of Contact

• Title: Joaquim Pinheiro, MD, MPH
• Organization: Albany Medical Center

pinheij@amc.edu

518-262-5421

Study Officials

• Joaquim M Pinheiro, MD, MPH

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: June 1, 2014
• Primary Completion: May 20, 2020
• Study Completion: December 31, 2020
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-08

Locations

US (1)