Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants

Summary

Participation Requirements

Description

Prenatal consent will be obtained on infant's with estimated gestational age of 23+0 to 27+6. Shortly before delivery, infant's will be randomly assigned to receive either Low oxygen concentration (FiO2 .30) OR High oxygen concentration (FiO2 1.0) during 60 seconds of delayed cord clamping. Randomiz...

Prenatal consent will be obtained on infant's with estimated gestational age of 23+0 to 27+6. Shortly before delivery, infant's will be randomly assigned to receive either Low oxygen concentration (FiO2 .30) OR High oxygen concentration (FiO2 1.0) during 60 seconds of delayed cord clamping. Randomization and intervention will remain blinded to the clinical care team during the entire study period. The research team member will open a randomization card when notified of a subject's impending birth, review the protocol with the obstetric provider performing the procedure, set-up the sterile special bed, and note the time it takes from delivery until the clamping and cutting of the umbilical cord in both groups. The research team member will set the oxygen blender as indicated by the randomization card and cover the blender to blind the FiO2 setting. The research team member will not be involved in the clinical care of the infant. The oxygen blender will be concealed from the clinical care team to ensure resuscitation maneuvers will not be biased. Data will be submitted to the statistician, who will remain blinded to the intervention for the duration of the study. If an infant is randomized to the DCC and Low Oxygen concentration (DCC LO group), the following procedure will ensue: At delivery, the infant will be placed on a special bed that allows the infant to be close to the mother, adequate to keep the umbilical cord intact. These beds are equipped with an oxygen blender, humidifier, t-piece resuscitator with mask, necessary to provide CPAP/PPV. During delayed cord clamping, breathing assistance with CPAP of 5 cm H20 or positive pressure ventilation (starting PIP of 20 cm H20) and a FiO2 .30 oxygen. The infant's face will be dried and a non-sterile mask will be placed on the infant's face to deliver pressure to help open their lungs. The infant will remain on this support up until the umbilical cord is clamped. Once the cord is clamped, resuscitation will continue according to unit protocol. If an infant is randomized to the DCC and High Oxygen concentration (DCC HI group), the following procedure will ensue: At delivery, the infant will be placed on a special bed that allows the infant to be close to the mother, adequate to keep the umbilical cord intact. These beds are equipped with an oxygen blender, humidifier, t-piece resuscitator with mask, necessary to provide CPAP/PPV. During delayed cord clamping, breathing assistance with CPAP of 5 cm H20 or positive pressure ventilation (starting PIP of 20 cm H20) and a FiO2 1.0 oxygen. The infant's face will be dried and a non-sterile mask will be placed on the infant's face to deliver pressure to help open their lungs. The infant will remain on this support up until the umbilical cord is clamped. Once the cord is clamped, resuscitation will continue according to unit protocol. Patency of the airway will be assessed by a Colorimetric CO2 detector. Lack of color change will indicate that the airway is not patent (obstructed), the pressure is not sufficient to expand the lungs, there was excessive air leak, or there was no or inadequate pulmonary blood flow. If there is no color change, the neonatal provider will reposition and reattempt to open the airway with CPAP or PPV. PIP pressures can be increased if there is no change in color by the CO2 detector. The Near-Infrared Spectroscopy (NIRS) will be applied once the infant is considered stable by the medical team. The NIRS sensor will be placed on the infant's forehead. Cerebral StO2, SpO2, blood pressure (once in the NICU) and Heart rate will be recorded every two seconds and linked with other variables. These variables will continue to be recorded for the first 24 hours of life.

Tracking Information