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

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ClinicalTrials.gov Identifier: NCT02164734
Recruitment Status : Recruiting
First Posted : June 17, 2014
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
University of Rochester
ONY
Information provided by (Responsible Party):
Joaquim M.B. Pinheiro, Albany Medical College

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.


Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Device: Endotracheal intubation Device: Laryngeal mask airway Drug: remifentanil Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Rescue Surfactant Delivery Via Endotracheal Intubation (INSURE Technique) Versus Laryngeal Mask Airway (LMA) for Respiratory Distress Syndrome (RDS) in Preterm Neonates
Study Start Date : June 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Active Comparator: Endotracheal intubation
Endotracheal intubation for surfactant administration, following remifentanil and atropine pre-medication
Device: Endotracheal intubation
Other Name: INSURE

Drug: remifentanil
additional premedication in the endotracheal intubation/INSURE arm

Experimental: Laryngeal mask airway
Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication
Device: Laryngeal mask airway
Other Name: LMA North America




Primary Outcome Measures :
  1. Avoidance of invasive mechanical ventilation [ Time Frame: 120 hours ]
    Rate of success of success 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)


Secondary Outcome Measures :
  1. Number of surfactant doses [ Time Frame: 120 hours ]
  2. Days on any respiratory support [ Time Frame: 3 months ]
  3. Rate of Pneumothorax [ Time Frame: 120 hours ]
  4. Rate of bronchopulmonary dysplasia (O2 dependence at the later of 28 days of age or 36 weeks postmenstrual age) [ Time Frame: 3 months ]
  5. Complications during insertion of LMA or endotracheal tube [ Time Frame: 120 hours ]
  6. Mortality rate [ Time Frame: 3 months ]
    Mortality prior to hospital discharge


Other Outcome Measures:
  1. Early failure of surfactant therapy [ Time Frame: 1 hour ]
    need of mechanical ventilation within 1 hour of surfactant therapy



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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164734


Contacts
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Contact: Joaquim M Pinheiro, MD, MPH 518-262-5421 pinheij@mail.amc.edu
Contact: Sussan Mbi Ndakor, MD 518-262-5421 mbindas@mail.amc.edu

Locations
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United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Joaquim M Pinheiro, MD, MPH    518-262-5421    pinheij@mail.amc.edu   
Contact: Sussan Mbi Ndakor, MD    518-262-5421    mbindas@mail.amc.edu   
Sponsors and Collaborators
Albany Medical College
University of Rochester
ONY
Investigators
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Principal Investigator: Joaquim M Pinheiro, MD, MPH Albany Medical College

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Responsible Party: Joaquim M.B. Pinheiro, Professor of Pediatrics, Albany Medical College
ClinicalTrials.gov Identifier: NCT02164734     History of Changes
Other Study ID Numbers: 3768
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Keywords provided by Joaquim M.B. Pinheiro, Albany Medical College:
surfactant
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Remifentanil
Pulmonary Surfactants
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Respiratory System Agents