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Supreme-LMA for Neonatal Resuscitation: a Prospective, Randomized Single-center Study

NCT01963936 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2013-10-16

No results posted yet for this study

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.

Conditions

  • Neonatal Resuscitation

Interventions

DEVICE

Supreme LMA

DEVICE

Facial mask

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
5 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-12-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01963936 on ClinicalTrials.gov