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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nCPAP Control Group | Active Comparator | Infants in the Control Group were maintained continuously on nasal CPAP 6 cm H2O with no surfactant administered. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal continuous positive airway pressure (nCPAP) | Device | nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of CPAP Therapy | During first seven days of life | |
| Duration of Oxygen Therapy | During first seven days of life | |
| Incidence of Pulmonary Airleaks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92350 | United States | ||
| University of California- San Diego Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37919512 | Derived | 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. | |
| 37503152 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | nCPAP Control Group | Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. |
| FG001 | LMA Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Laryngeal Mask Airway (LMA) to deliver surfactant | Device | Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA) |
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| Surfactants, Pulmonary | Drug | Curosurf®, Chiesi USA, Inc., Cary, NC |
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| First 7 days of life |
| Incidence of Severe IVH or PVL | During hospitalization |
| Incidence of Chronic Lung Disease | Measured at hospital discharge |
| San Diego |
| California |
| 92103 |
| United States |
| Maple Grove Hospital | Maple Grove | Minnesota | 55369 | United States |
| University of Minnesota Children's Hospital | Minneapolis | Minnesota | 55455 | United States |
| North Memorial Hospital | Robbinsdale | Minnesota | 55422 | United States |
| St Paul Children's Hospital | Saint Paul | Minnesota | 55102 | United States |
| University of Wisconsin- Madison | Madison | Wisconsin | 53715 | United States |
| 29174079 | 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. |
Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | nCPAP Control Group | Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. |
| BG001 | LMA Group | Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Gestational age | Mean | Standard Deviation | weeks |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Seven days |
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| Secondary | Duration of CPAP Therapy | Posted | Mean | Standard Deviation | hours | During first seven days of life |
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| Secondary | Duration of Oxygen Therapy | Posted | Mean | Standard Deviation | hours | During first seven days of life |
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| Secondary | Incidence of Pulmonary Airleaks | Posted | Count of Participants | Participants | First 7 days of life |
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| Secondary | Incidence of Severe IVH or PVL | Posted | Count of Participants | Participants | During hospitalization |
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| Secondary | Incidence of Chronic Lung Disease | Posted | Count of Participants | Participants | Measured at hospital discharge |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | nCPAP Control Group | Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. | 0 | 53 | 5 | 53 | ||
| EG001 | LMA Group | Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA) | 0 | 50 | 4 | 50 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kari D. Roberts, MD | Unviersity of Minnesota | 612-625--9577 | rober694@umn.edu |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| D017214 | Laryngeal Masks |
| D011663 | Pulmonary Surfactants |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
| D007442 | Intubation, Intratracheal |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D019141 | Respiratory System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| >=65 years |
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| Male |
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