NCT01963936

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

1.4 years

First QC Date

October 11, 2013

Last Update Submit

October 15, 2013

Conditions

Neonatal Resuscitation

Keywords

Infant newbornLaryngeal mask airwayPositive pressure ventilationResuscitation

Outcome Measures

Primary Outcomes (1)

  • Proportion of newborns needing endotracheal intubation

    10 minutes of life

Secondary Outcomes (3)

  • Time to first breath

    30 minutes of life

  • Proportion of patients needing Chest compressions and medications

    30 minutes of life

  • Proportion of patients with hypoxic ischemic encephalopathy

    1 week of life

Study Arms (2)

Supreme LMA

EXPERIMENTAL
Device: Supreme LMA

Facial mask

ACTIVE COMPARATOR
Device: Facial mask

Interventions

Supreme LMADEVICE
Supreme LMA
Facial maskDEVICE
Facial mask

Eligibility Criteria

AgeUp to 5 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants with gestational age ≥34 weeks, an expected birth weight \>1.500 g, needing positive pressure ventilation at birth.

You may not qualify if:

  • Lethal anomalies, hydrops, major malformations of the respiratory system, congenital heart disease, and stillbirths

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatal Intensive Care

Hanoi, Vietnam

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26003882DERIVED

  • 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.

    PMID: 25027230DERIVED

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 11, 2013

First Posted

October 16, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2013

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

VN(1)