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

Neonatal Resuscitation Clinical Trial

Official title:

NEWBORN VENTILATION IN THE DELIVERY ROOM: CAN IT BE IMPROVED WITH A LARYNGEAL MASK AIRWAY? A Prospective, Randomized Single-center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01963936
• Other study ID #: SLMA in neonatal resuscitation
• Status: Recruiting
• Phase: Phase 3
• First received: October 11, 2013
• Last updated: October 15, 2013
• Start date: July 2012

Study information

• Verified date: October 2013
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Minutes

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Resuscitation

Intervention

Device:
• Supreme LMA

• Facial mask

Locations

Country	Name	City	State
Vietnam	Department of Neonatal Intensive Care	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of newborns needing endotracheal intubation		10 minutes of life
Secondary	Time to first breath		30 minutes of life
Secondary	Proportion of patients needing Chest compressions and medications		30 minutes of life
Secondary	Proportion of patients with hypoxic ischemic encephalopathy		1 week of life	Yes