Trial Outcomes & Findings for Umbilical Cord Milking in Non-Vigorous Infants (NCT NCT03631940)

10 sites were randomized to perform umbilical cord milking or early cord clamping for eligible neonate-mother dyads. Research staff at each sites approached eligible neonate-mother dyads after delivery for written informed consent for additional data collection. Hospital recruited neonate-mother dyads in the initial period from January 2019 to January 2020 and from February 2020 and May 2021 for the crossover period. Neonate-mother dyads participated in a single period of the study.

Prior to the initiation of recruitment each participating hospital was assigned to perform umbilical cord milking or early cord clamping on non-vigorous neonates-mother dyads delivered during the recruitment period. Prior to the start of recruitment in the crossover study period (Study Period 2) a 1-2-month washout period was specified by the protocol for the purpose of site hospital staff retraining and to assess adherence to the new assigned intervention.

Unit of analysis: Hospitals

Baseline data including maternal age was only collected from participants who provided written consent for additional data collection or via waiver of consent for sites with ethics board approval.

Number of neonatal participants admitted to the neonatal intensive care unit for study-specific predefined criteria including respiratory distress, oxygen desaturation, hypoglycemia, hypotonia, apnea, lethargy or difficulty arousing, hypertonia or irritability, temperature instability, bradycardia or tachycardia, seizures or seizure-like activity, poor feeding or emesis, hyperbilirubinemia, death before NICU admission.

Single hemoglobin measurement for the neonate which was obtained between 12 to 48 hours of life collected with written consent or as part of standard care.

Number of neonates that were treated with therapeutic hypothermia (Cooling to 33.5 degrees Celsius) for 72 hours and initiated within the first 6 hours of life.

Number of neonates treated with normal saline bolus in the first 24 hours of life to support blood pressure.

Highest single measurement of total serum bilirubin obtained as part of standard care to assess hyperbilirubinemia in neonate.

Highest single measurement of transcutaneous bilirubin obtained as part of standard care to assess hyperbilirubinemia in each neonate.

Number of neonatal deaths prior to discharge

Number of neonates with a diagnosis of mild, moderate or severe hypoxic ischemic encephalopathy during neonatal intensive care unit admission.

Number of days neonate was admitted to the neonatal intensive care unit from birth to discharge home.

First single neonatal blood pressure measurement by cuff or arterial line obtained on admission to the neonatal intensive care unit and by 48 hours of life.

Neonates were assessed for poor tone, poor color (pale, dusky, cyanotic) and poor breathing effort by obstetric provider as part of standard care. Resuscitation assessment and interventions were conducted by neonatal intensive care clinical team. Recorded resuscitation interventions included: use of supplemental oxygen, continuous positive airway pressure respiratory support, positive pressure ventilation respiratory support, endotracheal intubation, chest compressions, epinephrine, normal saline bolus and other cardiorespiratory support medications. Resuscitation interventions including cardiorespiratory support were determined by individual site's clinical standards.