Clinical Trials Logo

Clinical Trial Summary

The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping and for infants who are non-vigorous at birth and need immediate resuscitation.


Clinical Trial Description

Hypoxic-ischemic encephalopathy (HIE) is a brain injury caused by inadequate blood flow and oxygen delivery to the neonatal brain. Almost all infants with severe HIE and 30-50% infants with moderate HIE either die or develop significant developmental delay, cerebral palsy or other disabilities.The incidence of HIE is 1-3 per 1,000 term births in developed countries and 15-20 times higher in developing countries (Worldwide, 0.5 to 1 million infants develop HIE each year). Therapeutic hypothermia is the only proven therapy for infants with HIE. Even after receiving therapeutic hypothermia, one-half of all infants with moderate and severe HIE die or develop neurological and functional impairment. Therapeutic hypothermia is not widely available and ineffective in developing nations.There is an urgent need for a new therapy for neonates with HIE, which can complement hypothermia and be readily available in developing nations. Stem cell transplantation is a potential therapy for infants with HIE. Umbilical cord blood is a rich source of stem cells. Umbilical cord milking (UCM) may have similar effect as autologous umbilical cord blood cell transplantation. Preliminary evidence suggests a placental transfusion in term infants may be a neuroprotective mechanism that can also facilitate cardiovascular transition for neonates depressed at birth and result in decreased mortality and improved neurodevelopmental outcomes. Infants with HIE, due to varied complications during the birth process, have poor perfusion due to fetal blood volume loss to the placenta. However, the most common method of providing placental blood, delayed cord clamping (DCC) cannot be performed since infants with HIE are non-vigorous and providers often need to perform resuscitation immediately after birth. The World Health Organization and the American College of Obstetrics and Gynecology (ACOG) also does not recommended DCC in neonates who are non-vigorous (limp, pale, and not breathing) at birth and require immediate resuscitation. Umbilical cord milking (UCM) or gently squeezing cord blood toward the baby, is an alternative to DCC, which can achieve significant placental transfusion without delaying resuscitation. Further, UCM can be completed as quickly as immediate cord clamping (ICC) and UCM requires minimal training and no additional staff. The investigators hypothesized that UCM will reduce the number of infants developing moderate to severe HIE or death in neonates who are non-vigorous at birth compared to early cord clamping (ECC). This will be a cluster crossover randomized controlled trial. Each hospital will be randomly assigned to use either ECC or UCM for any infant who is non-vigorous at birth and needing resuscitation over a period of 6 months. Then the site will change to the other method for an additional 6 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03657394
Study type Interventional
Source Nemours Children's Clinic
Contact Zubair H Aghai, MD
Phone 215 955 6523
Email zaghai@nemours.org
Status Recruiting
Phase N/A
Start date October 17, 2022
Completion date June 16, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05048550 - Babies in Glasses; a Feasibility Study. N/A
Recruiting NCT05514340 - Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy Phase 2
Recruiting NCT05836610 - Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates Phase 4
Completed NCT03024021 - Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
Completed NCT01913340 - Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO) Phase 1/Phase 2
Enrolling by invitation NCT02260271 - Florida Neonatal Neurologic Network
Terminated NCT01192776 - Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE) N/A
Completed NCT06344286 - The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE N/A
Recruiting NCT05901688 - Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes
Recruiting NCT02894866 - Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy N/A
Recruiting NCT03682042 - Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up N/A
Withdrawn NCT03681314 - Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU) N/A
Completed NCT03485781 - Propofol-induced EEG Changes in Hypoxic Brain Injury
Not yet recruiting NCT06429007 - A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury Phase 2
Recruiting NCT05568264 - Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit N/A
Not yet recruiting NCT06448780 - Dose Optimization of Caffeine for HIE Phase 1
Completed NCT02264808 - Developmental Outcomes
Completed NCT05687708 - Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia N/A
Recruiting NCT06195345 - Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
Withdrawn NCT05295784 - PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia Phase 1