Intact cord resuscitation using heart rate as a primary driver versus standard resuscitation among vaginally born term and late preterm infants requiring resuscitation - A randomized control trial

Asphyxia in the peripartum period of the fetus is a burden accounting for one in fifths of all neonatal deaths and tenth of under 5 mortalities.1 In India, perinatal asphyxia accounts for 28.8 % mortality in infant period .   Advent of evidence-based perinatal medicine and neonatology has led to a clear understanding of the transitional physiology, of the phenomenon that is called “parturition “.The transition from intrauterine to extrauterine life at birth relies on major physiological changes. These changes include clearing of liquid from the distal lung to allow gas- exchange, increasing pulmonary blood flow by decreasing pulmonary vasculature resistance and increasing systemic vascular resistance, cessation of umbilical venous return, occlusion for various fetal shunt, and increasing oxygen saturation.

Although most ( 85%) infants initiate spontaneous breathing within the first 10 to 30s of birth, with an additional 10% responding during drying and stimulation, 3- 5% will initiate respirations after positive-pressure ventilation (PPV), with rest requiring further advanced support.

Initiation of PPV during resuscitation is primarily based on breathing effort or heart rate as defined by NRP 2020 in infants who fail to achieve spontaneous breathing within 1 minutes of birth (compromised infant). However, Recent recommendations from the American Academy of Pediatrics (AAP 2015) and the International Liaison Committee of Resuscitation (ILCOR 2015) state the importance of heart rate (HR) as the most vital of vital signs during the neonatal transition and/or resuscitation. Since obtaining a reliable continuous heart rate in the initial one minutes may be tedious work, resuscitation in the initial one minutes is primarily based on breathing efforts or a single HR obtained by auscultation along the left side of heart.

Furthermore, during resuscitation, an increase in the infant’s heart rate is regarded as the most sensitive indicator of a successful response to the interventions required. Therefore, finding a fast, reliable, and precise method to measure the infant’s heart rate is crucial.

HR also helps in differentiating the primary apnea from secondary apnea which is important for resuscitation as primary apnea responds to initial stimulation whereas secondary apnea is associated with the need of PPV and delaying PPV can result in brain injury in asphyxiating infants.

Until now, measuring fast and reliable heart rate within the initial 60 seconds of birth is often difficult with several studies have demonstrated that HR by auscultation, palpation and pulse oximetry were inaccurate.

However, newer novel technologies are currently under evaluation to overcome this limitation with the most promising results from dry ECG electrode methods to capture HR within an initial 1 minute.

While the availability of an earlier, more accurate HR with newer techniques like dry electrodes would seem useful on the surface, it has not been established whether this information has an impact on the timing or initiation of different resuscitation interventions and its usefulness to initiate timely resuscitation in infants with intact cord  (ICR).

Therefore, we proposed to conduct an RCT to demonstrate whether using HR as the primary driver can rationalize resuscitation in vaginally born more than or equal to 35 weeks new-born with ICR.