Respiratory Distress SyndromeNCT01116921
Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
A study testing Nasal continuous positive airway pressure (nCPAP), Laryngeal Mask Airway (LMA) to deliver surfactant and Surfactants, Pulmonary in people with Respiratory Distress Syndrome, run by University of Minnesota at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 36 hours
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Nasal continuous positive airway pressure (nCPAP), Laryngeal Mask Airway (LMA) to deliver surfactant and Surfactants, Pulmonary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2011to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Loma Linda University Medical Center
Loma Linda, California, 92350
University of Wisconsin- Madison
Madison, Wisconsin, 53715
Maple Grove Hospital
Maple Grove, Minnesota, 55369
University of Minnesota Children's Hospital
Minneapolis, Minnesota, 55455
North Memorial Hospital
Robbinsdale, Minnesota, 55422
St Paul Children's Hospital
Saint Paul, Minnesota, 55102
University of California- San Diego Medical Center
San Diego, California, 92103
About this study
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.
Read the 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
- Being tested
- Nasal continuous positive airway pressure (nCPAP), Laryngeal Mask Airway (LMA) to deliver surfactant, Surfactants, Pulmonary
- Keywords
- laryngeal mask airway, surfactant, respiratory distress syndrome, neonate
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal continuous positive airway pressure (nCPAP)Device
nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
Laryngeal Mask Airway (LMA) to deliver surfactantDevice
Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
Surfactants, PulmonaryDrug
Curosurf®, Chiesi USA, Inc., Cary, NC
| Study group | Role | What they receive |
|---|---|---|
| nCPAP Control Group | Active comparator | Infants in the Control Group were maintained continuously on nasal CPAP 6 cm H2O with no surfactant administered. Receives: 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. Receives: Device: Nasal continuous positive airway pressure (nCPAP); Device: Laryngeal Mask Airway (LMA) to deliver surfactant; Drug: Surfactants, Pulmonary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Seven days
Secondary outcomes (5)
Duration of CPAP Therapy
Measured: During first seven days of life
Duration of Oxygen Therapy
Measured: During first seven days of life
Incidence of Pulmonary Airleaks
Measured: First 7 days of life
Incidence of Severe IVH or PVL
Measured: During hospitalization
Incidence of Chronic Lung Disease
Measured: Measured at hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startFeb 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kari D Roberts, M.D., Study chair, University of Minnesota Masonic Children's HospitalSijani Tipnis, M.D., Principal investigator, University of California, San DiegoAndrea L Lampland, M.D., Principal investigator, St Paul Children's HospitalAllen Merritt, M.D., Principal investigator, Loma Linda UniversityErin Stepka, M.D., Principal investigator, Maple Grove Hospital and North Memorial HospitalJulie Kessel, M.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116921
- Sponsor's protocol ID
- 1004M81177
- Status last verified
- Jan 2017
- First submitted
- 3 May 2010
- Last updated
- 27 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37919512Roberts 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.
PubMed 37503152Roberts 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.
PubMed 29174079
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates
- ClinicalTrials.gov ID
- NCT01116921
- Acronym / sponsor ID
- 1004M81177
- Conditions
- Respiratory Distress Syndrome
- Keywords
- laryngeal mask airway, surfactant, respiratory distress syndrome, neonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Posted 27 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nCPAP Control Group | Active comparator | Device: Nasal continuous positive airway pressure (nCPAP)Infants in the Control Group were maintained continuously on nasal CPAP 6 cm H2O with no surfactant administered. |
| LMA Group | Experimental | Device: Nasal continuous positive airway pressure (nCPAP), Device: Laryngeal Mask Airway (LMA) to deliver surfactant, Drug: Surfactants, PulmonaryOnce 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. |
Who may qualify
- Ages
- Up to 36 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal continuous positive airway pressure (nCPAP)nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU. | Device | LMA Group, nCPAP Control Group |
| Laryngeal Mask Airway (LMA) to deliver surfactantLaryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA) | Device | LMA Group |
| Surfactants, PulmonaryCurosurf®, Chiesi USA, Inc., Cary, NC | Drug | LMA Group |
Primary outcome
Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.
Time frame: 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.
5 secondary outcomes
Duration of CPAP Therapy
Time frame: During first seven days of life
Duration of Oxygen Therapy
Time frame: During first seven days of life
Incidence of Pulmonary Airleaks
Time frame: First 7 days of life
Incidence of Severe IVH or PVL
Time frame: During hospitalization
Incidence of Chronic Lung Disease
Time frame: Measured at hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37919512Wanous 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.
- Derived from this study: PubMed 37503152Roberts 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.
- Derived from this study: PubMed 29174079Roberts 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari D Roberts, M.D. study chair
University of Minnesota Masonic Children's Hospital
Sijani Tipnis, M.D. principal investigator
University of California, San Diego
Andrea L Lampland, M.D. principal investigator
St Paul Children's Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal continuous positive airway pressure (nCPAP), Laryngeal Mask Airway (LMA) to deliver surfactant and Surfactants, Pulmonary in people with Respiratory Distress Syndrome, run by University of Minnesota at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for Intubation and Mechanical Ventilation in the First Seven Days of Life. (time frame: Seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01116921, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.