Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation

NCT01042600 | Completed Phase 4 Results DMC

• 1 other identifier: 2599
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway(inserted after pre-medication for pain), or to surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and return babies to nasal CPAP, 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 CPAP (needs mechanical ventilation) or, b) late, if the baby requires 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 with standard surfactant treatment following sedation and endotracheal intubation.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Respiratory distress syndrome; Surfactant; Tracheal intubation; Laryngeal mask airway; Newborn

Outcome Measures

Primary Outcomes (1)

• Rate of Failure of Surfactant Therapy, Either Early (Need for Mechanical Ventilation Within 1 Hour), or Late (FiO2 > 0.60 to Maintain Target SpO2, or Second Dose of Surfactant Within 8 Hours, or Needing More Than 2 Doses of Surfactant).

  96 hours

Secondary Outcomes (7)

• Number of Surfactant Doses

  96 hr

• Days on Assisted Ventilation

  2 months

• Days on Supplemental Oxygen

  2 months

• Rate of Pneumothorax

  96 hrs

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

  2 months

Study Arms (2)

Endotracheal intubation

ACTIVE COMPARATOR

Endotracheal tube insertion for surfactant administration, following morphine and atropine pre-medication

Device: Endotracheal tube insertion

Laryngeal mask airway

EXPERIMENTAL

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

Device: Laryngeal mask airway insertion

Interventions

Endotracheal tube insertion DEVICE

Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)

Endotracheal intubation

Laryngeal mask airway insertion DEVICE

Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)

Also known as: LMA North America

Laryngeal mask airway

Eligibility Criteria

• Age: 4 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Mild-to-moderate RDS
• Postnatal age 4 to 48 hours
• Gestational age 29 0/7 to 36 6/7 weeks
• Treated with nasal CPAP ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at least 2 hours to maintain SpO2 88-95%
• Informed consent

You may not qualify if:

• Weight \< 1000 g
• Airway anomalies
• Pulmonary air leaks
• Craniofacial or cardiothoracic malformations

Sponsors & Collaborators

• Albany Medical College: lead
• ONY: collaborator
• LMA North America, Inc.: collaborator

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

pinheij@mail.amc.edu

518-262-5421

Study Officials

• Joaquim M Pinheiro, MD, MPH

  Albany Medical College

  PRINCIPAL INVESTIGATOR

• Querube Santana, MD

  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: January 4, 2010
• First Posted: January 5, 2010
• Study Start: December 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 26, 2019
• Results First Posted: July 16, 2014

Record last verified: 2019-07

Locations

US (1)