Respiratory Distress Syndrome
Conditions
Keywords
laryngeal mask airway, surfactant, respiratory distress syndrome, neonate
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.
Interventions
nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
DEVICELaryngeal Mask Airway (LMA) to deliver surfactant
Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
DRUGSurfactants, Pulmonary
Curosurf®, Chiesi USA, Inc., Cary, NC
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 36 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for Intubation and Mechanical Ventilation in the First Seven Days of Life. | Seven days | 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. |
Secondary
| Measure | 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 | First 7 days of life |
| Incidence of Severe IVH or PVL | During hospitalization |
| Incidence of Chronic Lung Disease | Measured at hospital discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| 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) | 50 |
| Total | 103 |
Baseline characteristics
| Characteristic | LMA Group | nCPAP Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 53 Participants | 103 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 32.71 weeks STANDARD_DEVIATION 1.86 | 32.86 weeks STANDARD_DEVIATION 1.86 | 32.71 weeks STANDARD_DEVIATION 1.86 |
| Gender Female | 20 Participants | 18 Participants | 38 Participants |
| Gender Male | 30 Participants | 35 Participants | 65 Participants |
| Region of Enrollment United States | 50 participants | 53 participants | 103 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 53 | 4 / 50 |
| serious Total, serious adverse events | 0 / 53 | 0 / 50 |
Outcome results
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.
Time frame: Seven days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| nCPAP Control Group | Need for Intubation and Mechanical Ventilation in the First Seven Days of Life. | 34 Participants |
| LMA Group | Need for Intubation and Mechanical Ventilation in the First Seven Days of Life. | 19 Participants |
p-value: 0.00695% CI: [0.13, 0.7]Regression, Logistic
Secondary
Duration of CPAP Therapy
Time frame: During first seven days of life
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| nCPAP Control Group | Duration of CPAP Therapy | 50 hours | Standard Deviation 41 |
| LMA Group | Duration of CPAP Therapy | 56 hours | Standard Deviation 35 |
Secondary
Duration of Oxygen Therapy
Time frame: During first seven days of life
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| nCPAP Control Group | Duration of Oxygen Therapy | 55 hours | Standard Deviation 41 |
| LMA Group | Duration of Oxygen Therapy | 56 hours | Standard Deviation 45 |
Secondary
Incidence of Chronic Lung Disease
Time frame: Measured at hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| nCPAP Control Group | Incidence of Chronic Lung Disease | 0 Participants |
| LMA Group | Incidence of Chronic Lung Disease | 2 Participants |
Secondary
Incidence of Pulmonary Airleaks
Time frame: First 7 days of life
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| nCPAP Control Group | Incidence of Pulmonary Airleaks | 5 Participants |
| LMA Group | Incidence of Pulmonary Airleaks | 4 Participants |
Secondary
Incidence of Severe IVH or PVL
Time frame: During hospitalization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| nCPAP Control Group | Incidence of Severe IVH or PVL | 0 Participants |
| LMA Group | Incidence of Severe IVH or PVL | 0 Participants |