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

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.

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 Overview

• Status: Unknown
• Conditions: Neonatal Resuscitation
• Intervention / Treatment: Device: Supreme LMA; Device: Facial mask

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Phase 3

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Recruiting
    • Department of Neonatal Intensive Care
    • Contact: Nguyen Thi Thanh Ha, MD; Phone Number: 84-4 38259281; Email: lienhe@benhvienphusantrunguong.org.vn
    • Contact: Daniele Trevisanuto, MD; Phone Number: 39 0498213545; Email: trevo@pediatria.unipd.it
    • Principal Investigator: Nguyen Thi Thanh Ha, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 minutes (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Facial mask	Device: Facial mask
Experimental: Supreme LMA	Device: Supreme LMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of newborns needing endotracheal intubation	10 minutes of life

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Padova

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: October 11, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 15, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Resuscitation; Laryngeal mask airway; Positive pressure ventilation; Infant newborn
• Other Study ID Numbers: SLMA in neonatal resuscitation