Neonatal ResuscitationPhase 3NCT01963936
Supreme-LMA for Neonatal Resuscitation: a Prospective, Randomized Single-center Study
A Phase 3 study testing Supreme LMA and Facial mask in people with Neonatal Resuscitation, run by University of Padova at 1 site in Vietnam.
Trial summary
Laryngeal mask airways (LMA) that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth. The LMA may be considered as an alternative to FM for positive pressure ventilation (PPV) among newborns weighing >2000 g or delivered >34 weeks' gestation. Read more about this study
- Who is it for?
- Ages Up to 5 minutes
- Conditions the study is for
- Neonatal Resuscitation
- What is being tested?
- Supreme LMA and Facial mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteVietnam
- Study dates
- Jul 2012to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 5 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with gestational age ≥34 weeks, an expected birth weight >1.500 g, needing positive pressure ventilation at birth.
Who cannot join
- Lethal anomalies, hydrops, major malformations of the respiratory system, congenital heart disease, and stillbirths
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Department of Neonatal Intensive Care
Hanoi
Nguyen Thi Thanh Ha, MD, 84-4 38259281, lienhe@benhvienphusantrunguong.org.vn
Daniele Trevisanuto, MD, 39 0498213545, trevo@pediatria.unipd.it
About this study
Official title: NEWBORN VENTILATION IN THE DELIVERY ROOM: CAN IT BE IMPROVED WITH A LARYNGEAL MASK AIRWAY? A Prospective, Randomized Single-center Study
Laryngeal mask airways (LMA) that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth. The LMA may be considered as an alternative to FM for positive pressure ventilation (PPV) among newborns weighing >2000 g or delivered >34 weeks' gestation.
A recent, quasi-experimental study provided the feasibility, efficacy and safety of using the LMA in neonatal resuscitation.
Read more
However, studies of LMA use for providing PPV during neonatal resuscitation are still limited. There are no published clinical randomized trials evaluating the LMA compared with the FM for neonatal resuscitation.
Hypothesis: Our hypothesis is based on the assumption that ventilating newborns needing PPV with a LMA will be more effective than ventilating with a FM by decreasing the proportion of resuscitated newborns needing ETT.
Objective: To compare the effectiveness of LMA and FM ventilation in newborns needing PPV at birth.
Design / Methods: An open, prospective, randomized, single center, clinical trial.
Intervention: PPV will be performed with a LMA (intervention group) or with a FM (control group) in all infant newborns weighing >2000 g or delivered >34 weeks gestation.
Primary outcome variable: Proportion of newborns needing endotracheal intubation.
Secondary outcome measures: Apgar score at 5 minutes, heart rate at 60, 90 seconds and 5 and 10 minutes, time to first breath, duration of PPV, for proportion of infants needing chest compressions, drugs and death within 1 week and/or presence of HIE, grade II or III, according to a modification of Sarnat and Sarnat.2,10 According to this classification, HIE grade I (mild) includes irritability, hyperalertness, mild hypotonia, and poor sucking; grade II (moderate) includes lethargy, seizures, marked abnormalities of tone, and requirement of tube feeding; and grade III (severe) includes coma, prolonged seizures, severe hypotonia, and failure to maintain spontaneous respiration.
The following data were collected during resuscitation: (1) Apgar score at 1 min and 5 min after birth; (2) LMA insertion time, the rate of successful insertion at the first attempt, and the number of attempts required to insert the LMA successfully; (3) duration of resuscitation: response time (the time period from starting LMA resuscitation to achieving an effective response), ventilation time; (4) adverse effects during resuscitation.
- Conditions
- Neonatal Resuscitation
- Being tested
- Supreme LMA, Facial mask
- Keywords
- Infant newborn, Laryngeal mask airway, Positive pressure ventilation, Resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supreme LMADevice
Facial maskDevice
| Study group | Role | What they receive |
|---|---|---|
| Supreme LMA | Experimental | Not described Receives: Device: Supreme LMA |
| Facial mask | Active comparator | Not described Receives: Device: Facial mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of newborns needing endotracheal intubation
Measured: 10 minutes of life
Secondary outcomes (3)
Time to first breath
Measured: 30 minutes of life
Proportion of patients needing Chest compressions and medications
Measured: 30 minutes of life
Proportion of patients with hypoxic ischemic encephalopathy
Measured: 1 week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal ResuscitationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donato Nitti, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963936
- Sponsor's protocol ID
- SLMA in neonatal resuscitation
- Status last verified
- Oct 2013
- First submitted
- 11 Oct 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Trevisanuto D, Cavallin F, Nguyen LN, Nguyen TV, Tran LD, Tran CD, Doglioni N, Micaglio M, Moccia L. Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial. J Pediatr. 2015 Aug;167(2):286-91.e1. doi: 10.1016/j.jpeds.2015.04.051. Epub 2015 May 21.
PubMed 26003882Trevisanuto D, Cavallin F, Mardegan V, Loi NN, Tien NV, Linh TD, Chien TD, Doglioni N, Chiandetti L, Moccia L. LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial. Trials. 2014 Jul 15;15:285. doi: 10.1186/1745-6215-15-285.
PubMed 25027230
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEWBORN VENTILATION IN THE DELIVERY ROOM: CAN IT BE IMPROVED WITH A LARYNGEAL MASK AIRWAY? A Prospective, Randomized Single-center Study
- ClinicalTrials.gov ID
- NCT01963936
- Acronym / sponsor ID
- SLMA in neonatal resuscitation
- Conditions
- Neonatal Resuscitation
- Keywords
- Infant newborn, Laryngeal mask airway, Positive pressure ventilation, Resuscitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (estimated)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laryngeal mask airways (LMA) that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth. The LMA may be considered as an alternative to FM for positive pressure ventilation (PPV) among newborns weighing >2000 g or delivered >34 weeks' gestation.
A recent, quasi-experimental study provided the feasibility, efficacy and safety of using the LMA in neonatal resuscitation.
However, studies of LMA use for providing PPV during neonatal resuscitation are still limited. There are no published clinical randomized trials evaluating the LMA compared with the FM for neonatal resuscitation.
Hypothesis: Our hypothesis is based on the assumption that ventilating newborns needing PPV with a LMA will be more effective than ventilating with a FM by decreasing the proportion of resuscitated newborns needing ETT.
Objective: To compare the effectiveness of LMA and FM ventilation in newborns needing PPV at birth.
Design / Methods: An open, prospective, randomized, single center, clinical trial.
Intervention: PPV will be performed with a LMA (intervention group) or with a FM (control group) in all infant newborns weighing >2000 g or delivered >34 weeks gestation.
Primary outcome variable: Proportion of newborns needing endotracheal intubation.
Secondary outcome measures: Apgar score at 5 minutes, heart rate at 60, 90 seconds and 5 and 10 minutes, time to first breath, duration of PPV, for proportion of infants needing chest compressions, drugs and death within 1 week and/or presence of HIE, grade II or III, according to a modification of Sarnat and Sarnat.2,10 According to this classification, HIE grade I (mild) includes irritability, hyperalertness, mild hypotonia, and poor sucking; grade II (moderate) includes lethargy, seizures, marked abnormalities of tone, and requirement of tube feeding; and grade III (severe) includes coma, prolonged seizures, severe hypotonia, and failure to maintain spontaneous respiration.
The following data were collected during resuscitation: (1) Apgar score at 1 min and 5 min after birth; (2) LMA insertion time, the rate of successful insertion at the first attempt, and the number of attempts required to insert the LMA successfully; (3) duration of resuscitation: response time (the time period from starting LMA resuscitation to achieving an effective response), ventilation time; (4) adverse effects during resuscitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supreme LMA | Experimental | Device: Supreme LMA |
| Facial mask | Active comparator | Device: Facial mask |
Who may qualify
- Ages
- Up to 5 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with gestational age ≥34 weeks, an expected birth weight >1.500 g, needing positive pressure ventilation at birth.
Key exclusion criteria (1 listed)
- Lethal anomalies, hydrops, major malformations of the respiratory system, congenital heart disease, and stillbirths
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 |
|---|---|---|
| Supreme LMA | Device | Supreme LMA |
| Facial mask | Device | Facial mask |
Primary outcome
Proportion of newborns needing endotracheal intubation
Time frame: 10 minutes of life
3 secondary outcomes
Time to first breath
Time frame: 30 minutes of life
Proportion of patients needing Chest compressions and medications
Time frame: 30 minutes of life
Proportion of patients with hypoxic ischemic encephalopathy
Time frame: 1 week of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- Derived from this study: PubMed 26003882Trevisanuto D, Cavallin F, Nguyen LN, Nguyen TV, Tran LD, Tran CD, Doglioni N, Micaglio M, Moccia L. Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial. J Pediatr. 2015 Aug;167(2):286-91.e1. doi: 10.1016/j.jpeds.2015.04.051. Epub 2015 May 21.
- Derived from this study: PubMed 25027230Trevisanuto D, Cavallin F, Mardegan V, Loi NN, Tien NV, Linh TD, Chien TD, Doglioni N, Chiandetti L, Moccia L. LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial. Trials. 2014 Jul 15;15:285. doi: 10.1186/1745-6215-15-285.
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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.
Department of Neonatal Intensive Care
Hanoi, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supreme LMA and Facial mask in people with Neonatal Resuscitation, run by University of Padova at 1 site in Vietnam.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of newborns needing endotracheal intubation (time frame: 10 minutes of life). 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 NCT01963936, which also lists 2 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 16 Oct 2013.