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