Supreme-LMA for Neonatal Resuscitation: a Prospective, Randomized Single-center Study
NCT ID: NCT01963936
Last Updated: 2013-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
142 participants
INTERVENTIONAL
2012-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Supreme LMA
Supreme LMA
Facial mask
Facial mask
Interventions
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Supreme LMA
Facial mask
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
5 Minutes
ALL
No
Sponsors
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University of Padova
OTHER
Responsible Party
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Donato Nitti
Professor
Locations
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Department of Neonatal Intensive Care
Hanoi, , Vietnam
Countries
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Facility Contacts
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Nguyen Thi Thanh Ha, MD
Role: primary
Daniele Trevisanuto, MD
Role: backup
References
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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.
Trevisanuto 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.
Other Identifiers
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SLMA in neonatal resuscitation
Identifier Type: -
Identifier Source: org_study_id