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

University of Padova

Status and phase: Unknown; Phase 3

Conditions: Neonatal Resuscitation

Treatments: Device: Supreme LMA; Device: Facial mask

Study type: Interventional

Funder types: Other

Identifiers

NCT01963936

SLMA in neonatal resuscitation

Details and patient eligibility

About

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.

Enrollment: 142 estimated patients

Sex: All

Ages: Under 5 minutes old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

142 participants in 2 patient groups

Supreme LMA

Experimental group

Treatment:

Device: Supreme LMA

Facial mask

Active Comparator group

Treatment:

Device: Facial mask