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| Name | Class |
|---|---|
| Lata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur, India | UNKNOWN |
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The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.
Hypoxic-ischemic encephalopathy (HIE) is a brain injury in neonates due to inadequate blood flow and oxygen delivery to the neonatal brain. Umbilical cord milking can potentially improve brain injury in neonates with HIE. The objective of this study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth. The investigators hypothesized that umbilical cord milking is feasible and safe in neonates who are depressed at birth. The investigators also hypothesized that umbilical cord milking will increase stem cells in neonatal blood circulation and improve short term outcomes in neonates with moderate and severe HIE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate cord clamping | No Intervention | At birth, neonate will be held at the level of placenta and umbilical cord will be clamped immediately (standard of care for depressed neonates). | |
| Umbilical cord milking | Experimental | At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Milking | Procedure | At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of depressed neonates in whom umbilical cord milking was performed. | The number of neonates who are depressed at birth will be determined and the percentage of depressed neonates in whom UCM performed will be calculated. The investigators expect that more than 80% of neonates who qualify will receive UCM. The investigators will aslo compare resuscitation efforts (use of positive pressure ventilation, intubation, chest compression, medication and fluid boluses) and short term outcomes of resuscitation (5 minutes apgar, severity of HIE, blood gas at 1 hour) in neonates with and without UCM. | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates. | Evaluate stem and progenitor cell count in peripheral blood of neonates with UCM and compare them with the control group (no UCM). | 24 hours |
| The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lata Mangeshkar Hospital and NKP Salve Institute of Medical Sciences | Nagpur | MS | 440019 | India |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
Evaluate absolute monocyte and lymphocyte count in peripheral blood of neonates with UCM and compare them with the control group (no UCM). |
| 24 hours |
| The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates. | Compare levels of neurotrophic factors in peripheral blood of neonates with and without UCM. | 24 hours |
| Survival and short term outcomes in neonates with moderate and severe HIE | In infants with moderate or severe HIE, compare survival, neurological examination at discharge, and neuro-imaging studies in infants with and without UCM. | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |