Author Of 1 Presentation
RANDOMISED CONTROL TRIAL OF FOOT OPERATED RESUSCITATOR VERSUS ROUTINE BAG AND MASK FOR NEONATAL RESUSCITATION AT BIRTH
Abstract
Background
Foot operated newborn resuscitator (FOR) has been developed with intention of improving the ease with which newborn resuscitation can be carried out in neonates requiring positive pressure ventilation (PPV).
Objectives
The primary outcome was to determine the non-inferiority of foot operated resuscitator versus routine bag and mask ventilation (BMV) in increasing heart rate above 100/min after 30 seconds of PPV.
Methods
Study conducted in a teaching hospital providing tertiary level care for neonates. Neonates around 35 weeks gestation requiring newborn resuscitation and meeting pre-existing criteria for requirement of Bag and Mask ventilation were included in the study. Sample size was 60 neonates was needed to detect a mean difference of 1.78 with 80% power. Analysis was by intention to treat.
Results
60 cases were enrolled (31 in FOR; 29 in BMV). Foetal distress, HR>100 at 30/60 sec, neonate intubation, NICU admission and survival were similar in both groups (Chi square test). Mean (SD) time to establish spontaneous breathing in FOR [61.2(36.5)] was lower as compared to to BMV [114(126)]. (p value = 0.054). Median(IQR) time to establish spontaneous breathing FOR [60(30)] vs BMV [60(75)] was not different. The median(IQR) duration of noninvasive ventilation in seconds for FOR (60(30)) and Bag and Mask group (60(105))was comparable(p = 0.465). Variation in time taken is high in BMV suggesting that the FOR device is easier to operate by health personnel.
Conclusion
Foot operated resuscitator is as good as, if not better in providing positive pressure ventilation in neonates.