Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

NCT01116921 | Completed Results DMC

• 1 other identifier: 1004M81177
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 7

Brief Summary

The primary objective of this research is to compare the need for intubation and mechanical ventilation in the first seven days of life for infants with respiratory distress syndrome (RDS) on nasal continuous positive airway pressure (nCPAP) who receive surfactant via a Laryngeal Mask Airway (LMA) with those who are maintained on nCPAP and do not receive surfactant.

Conditions

Respiratory Distress Syndrome

Keywords

laryngeal mask airway; surfactant; respiratory distress syndrome; neonate

Outcome Measures

Primary Outcomes (1)

• Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.

  "Treatment Failure" criteria were the same for both groups. "Treatment Failure" required two of the following: 1) FiO2 \>40% for longer than 30 minutes (to maintain SaO2 88-92%), 2) PCO2 \>65mmHg on ABG/CBG or \>70 on VBG, or 3) pH\<7.22 on ABG/CBG/VBG or one of the following: 1) recurrent or severe apnea, 2) hemodynamic instability requiring pressors, 3) repeat surfactant dose at appropriate time with FiO2 \>40%, or 4) deemed necessary by medical provider.

  Seven days

Secondary Outcomes (5)

• Duration of CPAP Therapy

  During first seven days of life

• Duration of Oxygen Therapy

  During first seven days of life

• Incidence of Pulmonary Airleaks

  First 7 days of life

• Incidence of Severe IVH or PVL

  During hospitalization

• Incidence of Chronic Lung Disease

  Measured at hospital discharge

Study Arms (2)

nCPAP Control Group

ACTIVE COMPARATOR

Infants in the Control Group were maintained continuously on nasal CPAP 6 cm H2O with no surfactant administered.

Device: Nasal continuous positive airway pressure (nCPAP)

LMA Group

EXPERIMENTAL

Once proper placement of the LMA was achieved, surfactant (Curosurf®, 2.5 ml/kg, Chiesi USA, Inc., Cary, NC) was administered. The LMA cuff was then deflated, LMA removed and the infant placed back on nasal CPAP 6 cm H2O.

Device: Nasal continuous positive airway pressure (nCPAP); Device: Laryngeal Mask Airway (LMA) to deliver surfactant; Drug: Surfactants, Pulmonary

Interventions

Nasal continuous positive airway pressure (nCPAP) DEVICE

nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.

LMA Group; nCPAP Control Group

Laryngeal Mask Airway (LMA) to deliver surfactant DEVICE

Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)

LMA Group

Surfactants, Pulmonary DRUG

Curosurf®, Chiesi USA, Inc., Cary, NC

LMA Group

Eligibility Criteria

• Age: Up to 36 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age at time of enrollment 28 0/7 to 35 6/7 weeks postmenstrual age
• Age less than or equal to 36 hours old
• On nCPAP 6 with supplemental oxygen requirement (Fi02 greater than or equal to 30%) for greater than or equal to 30 minutes (to maintain Sa02 between 88-92%)
• Chest radiograph and clinical presentation consistent with respiratory distress syndrome (tachypnea, retractions, nasal flaring, and/or grunting

You may not qualify if:

• Prior mechanical ventilation or surfactant administration
• Major congenital anomaly
• Abnormality of the airway
• Respiratory distress secondary to an etiology other than respiratory distress syndrome (pneumothorax, meconium aspiration syndrome, pneumonia, hypoxic-ischemic encephalopathy)
• Apgar score \< 5 at 5 minutes of age

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (7)

Loma Linda University Medical Center

Loma Linda, California, 92350, United States

Location

University of California- San Diego Medical Center

San Diego, California, 92103, United States

Location

Maple Grove Hospital

Maple Grove, Minnesota, 55369, United States

Location

University of Minnesota Children's Hospital

Minneapolis, Minnesota, 55455, United States

Location

North Memorial Hospital

Robbinsdale, Minnesota, 55422, United States

Location

St Paul Children's Hospital

Saint Paul, Minnesota, 55102, United States

Location

University of Wisconsin- Madison

Madison, Wisconsin, 53715, United States

Location

Related Publications (3)

• Wanous AA, Brown R, Rudser KD, Roberts KD. Comparison of laryngeal mask airway and endotracheal tube placement in neonates. J Perinatol. 2024 Feb;44(2):239-243. doi: 10.1038/s41372-023-01818-x. Epub 2023 Nov 2.

  PMID: 37919512 DERIVED

• Roberts K, Wanous A, Brown R, Rudser K. Comparison of Laryngeal Mask Airway and Endotracheal Tube Placement in Neonates. Res Sq [Preprint]. 2023 Jul 13:rs.3.rs-3136331. doi: 10.21203/rs.3.rs-3136331/v1.

  PMID: 37503152 DERIVED

• Roberts KD, Brown R, Lampland AL, Leone TA, Rudser KD, Finer NN, Rich WD, Merritt TA, Czynski AJ, Kessel JM, Tipnis SM, Stepka EC, Mammel MC. Laryngeal Mask Airway for Surfactant Administration in Neonates: A Randomized, Controlled Trial. J Pediatr. 2018 Feb;193:40-46.e1. doi: 10.1016/j.jpeds.2017.09.068. Epub 2017 Nov 22.

  PMID: 29174079 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Continuous Positive Airway Pressure; Laryngeal Masks; Pulmonary Surfactants

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Intubation, Intratracheal; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Respiratory System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Kari D. Roberts, MD
• Organization: Unviersity of Minnesota

rober694@umn.edu

612-625--9577

Study Officials

• Kari D Roberts, M.D.

  University of Minnesota Masonic Children's Hospital

  STUDY CHAIR

• Sijani Tipnis, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Andrea L Lampland, M.D.

  St Paul Children's Hospital

  PRINCIPAL INVESTIGATOR

• Allen Merritt, M.D.

  Loma Linda University

  PRINCIPAL INVESTIGATOR

• Erin Stepka, M.D.

  Maple Grove Hospital and North Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Julie Kessel, M.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: February 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 27, 2017
• Results First Posted: February 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)