Clinical trial NCT01963936: Supreme-LMA for Neonatal Resuscitation: a Prospective, Randomized Single-center Study
Official title: NEWBORN VENTILATION IN THE DELIVERY ROOM: CAN IT BE IMPROVED WITH A LARYNGEAL MASK AIRWAY? A Prospective, Randomized Single-center Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Neonatal Resuscitation
Keywords: Infant newborn
Laryngeal mask airway
Positive pressure ventilation
Resuscitation
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 142
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of newborns needing endotracheal intubation
timeFrame: 10 minutes of life
Secondary outcomes:
measure: Time to first breath
timeFrame: 30 minutes of life
measure: Proportion of patients needing Chest compressions and medications
timeFrame: 30 minutes of life
measure: Proportion of patients with hypoxic ischemic encephalopathy
timeFrame: 1 week of life
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Department of Neonatal Intensive Care
Study officials:
References:
citation: 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.
citation: 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.