Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries (CORDMILK)
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| ClinicalTrials.gov Identifier: NCT03657394 |
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Recruitment Status :
Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : September 13, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypoxic-Ischemic Encephalopathy Birth Asphyxia | Other: Umbilical cord milking | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 3442 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | Cluster Randomized Crossover |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Cluster Randomized Clinical Trial of Umbilical Cord Milking Versus Early Cord Clamping on Short and Long-term Outcomes in Neonates Who Are Non-Vigorous at Birth |
| Estimated Study Start Date : | February 1, 2022 |
| Estimated Primary Completion Date : | January 31, 2023 |
| Estimated Study Completion Date : | January 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Umbilical Cord Milking
The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC.
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Other: Umbilical cord milking
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 1--15 seconds. |
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No Intervention: Early Cord Clamping
Umbilical cord will be clamped immediately after birth (within 60 seconds)
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- Moderate to severe HIE or death [ Time Frame: From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, asessed up to 10 weeks. ]Number of infants with moderate to severe HIE or death
- NICU Admission [ Time Frame: Delivery room death or admission to the NICU from the time of birth to 48 hours of age. ]Number of non-vigorous infants admitted to the NICU
- Neurological examination at discharge [ Time Frame: From date of birth until the date of discharge from the hospital, asessed up to 10 weeks. ]Number of infants with moderate to severe HIE who have abnormal neurological examination at discharge
- MRI of the brain [ Time Frame: 4 days to 2 weeks ]Number of infants with moderate to severe HIE who have abnormal brain MRI
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| Ages Eligible for Study: | 35 Weeks to 42 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Non-vigorous neonates born between 35-42 weeks
Exclusion Criteria:
- Congenital malformation of CNS.
- Chromosomal abnormalities.
- Major congenital malformations.
- Abruption/cutting through the placenta at delivery.
- Umbilical cord knots or inadequate cord length.
- Mono-chorionic twins or twins with no information on amnion/chorion.
- Multiple gestation >2 .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657394
| Contact: Zubair H Aghai, MD | 215 955 6523 | zaghai@nemours.org | |
| Contact: Anup Katheria, MD | 858 939 4170 | anup.katheria@sharp.com |
| India | |
| KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College | |
| Belgaum, Karnataka, India, 590010 | |
| Karnataka Institute of Medical Sciences | |
| Hubli, Karnataka, India, 580022 | |
| 4. Pravara Institute of Medical Sciences/The Rural Medical College and Hospital | |
| Loni, MS, India, 413736 | |
| Daga Memorial Woman and Children Hospital | |
| Nagpur, MS, India, 440002 | |
| Government Medical College and Hospital | |
| Nagpur, MS, India, 440009 | |
| All India Institute of Medical Science | |
| Nagpur, MS, India, 441108 | |
| Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital | |
| Wardha, MS, India, 442102 | |
| Jawaharlal Institute of Post graduate Medical Education and Research (JIPMER) | |
| Pondicherry, India, 605006 | |
| Contact: Adhisivam B, MD adhisivam1975@yahoo.co.uk | |
| Principal Investigator: Adhisivam B, MD | |
| Principal Investigator: Sasirekha Rengaraj, MD | |
| Sub-Investigator: A Ramesh, MD | |
| Sub-Investigator: Nivedita Mondal, MD | |
| Principal Investigator: | Zubair H Aghai, MD | Nemours Children's Clinic | |
| Principal Investigator: | Anup Katheria, MD | Sharp Mary Birch Hospital for Women & Newborns | |
| Principal Investigator: | Sangappa Dhaded, MD | KLE Academy of Higher Education and Research |
| Responsible Party: | Zubair Aghai, Professor Of Pediatrics, Nemours Children's Clinic |
| ClinicalTrials.gov Identifier: | NCT03657394 |
| Other Study ID Numbers: |
CORDMILK R01HD102967 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 5, 2018 Key Record Dates |
| Last Update Posted: | September 13, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Placental transfusion |
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Brain Diseases Brain Ischemia Hypoxia-Ischemia, Brain Asphyxia Neonatorum Asphyxia Central Nervous System Diseases Nervous System Diseases Hypoxia Signs and Symptoms, Respiratory |
Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Hypoxia, Brain Death Pathologic Processes Wounds and Injuries Infant, Newborn, Diseases |