Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates

NCT ID: NCT01116921

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2015-04-30

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.

Detailed Description

Secondary outcomes were total number of hours on mechanical ventilation, CPAP and supplemental oxygen during the first 7 days of life and for the entire hospitalization. Other secondary outcomes were number of surfactant doses, incidence of pulmonary air leak, survival until discharge, chronic lung disease (defined as need for oxygen at 36 weeks PMA), oxygen requirement at discharge, severe intraventricular hemorrhage (Grade 3/4), and periventricular leukomalacia.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nCPAP Control Group

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

Group Type: ACTIVE_COMPARATOR

Nasal continuous positive airway pressure (nCPAP)

Intervention Type: DEVICE

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

LMA Group

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.

Group Type: EXPERIMENTAL

Nasal continuous positive airway pressure (nCPAP)

Intervention Type: DEVICE

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

Laryngeal Mask Airway (LMA) to deliver surfactant

Intervention Type: DEVICE

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

Surfactants, Pulmonary

Intervention Type: DRUG

Curosurf®, Chiesi USA, Inc., Cary, NC

Interventions

Nasal continuous positive airway pressure (nCPAP)

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

Intervention Type: DEVICE

Laryngeal Mask Airway (LMA) to deliver surfactant

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

Intervention Type: DEVICE

Surfactants, Pulmonary

Curosurf®, Chiesi USA, Inc., Cary, NC

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Maximum Eligible Age: 36 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kari D Roberts, M.D.

Role: STUDY_CHAIR

University of Minnesota Masonic Children's Hospital

Sijani Tipnis, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Andrea L Lampland, M.D.

Role: PRINCIPAL_INVESTIGATOR

St Paul Children's Hospital

Allen Merritt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Erin Stepka, M.D.

Role: PRINCIPAL_INVESTIGATOR

Maple Grove Hospital and North Memorial Hospital

Julie Kessel, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Loma Linda University Medical Center

Loma Linda, California, United States

University of California- San Diego Medical Center

San Diego, California, United States

Maple Grove Hospital

Maple Grove, Minnesota, United States

University of Minnesota Children's Hospital

Minneapolis, Minnesota, United States

North Memorial Hospital

Robbinsdale, Minnesota, United States

St Paul Children's Hospital

Saint Paul, Minnesota, United States

University of Wisconsin- Madison

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37919512 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37503152 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29174079 (View on PubMed)

Other Identifiers

1004M81177

Identifier Type: -

Identifier Source: org_study_id