Hypoxic Ischemic Encephalopathy, Umbilical Cord Milking
Conditions
Brief summary
The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.
Detailed description
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.
Interventions
PROCEDUREUmbilical Cord Milking
At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.
Sponsors
Lata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur, India
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Minutes
Healthy volunteers
No
Inclusion criteria
* Term and near term neonates (35 weeks and more) * Depressed at birth
Exclusion criteria
* Congenital malformation of central nervous system * Chromosomal abnormalities * Major congenital malformations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of depressed neonates in whom umbilical cord milking was performed. | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates. | 24 hours | Evaluate stem and progenitor cell count in peripheral blood of neonates with UCM and compare them with the control group (no UCM). |
| The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates. | 24 hours | Evaluate absolute monocyte and lymphocyte count in peripheral blood of neonates with UCM and compare them with the control group (no UCM). |
| The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates. | 24 hours | Compare levels of neurotrophic factors in peripheral blood of neonates with and without UCM. |
| Survival and short term outcomes in neonates with moderate and severe HIE | Participants will be followed for the duration of hospital stay, an expected average of 5 days | In infants with moderate or severe HIE, compare survival, neurological examination at discharge, and neuro-imaging studies in infants with and without UCM. |
Countries
India
Outcome results
None listed