Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia
Conditions
Brief summary
The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to Immediate cord clamping.
Detailed description
Enrolled participants will be randomly allocated to one of two study groups: 1) Umbilical cord clamping, 2) Immediate cord clamping Umbilical cord clamping group: In the babies requiring resuscitation during vaginal delivery, the delivering obstetrician will place the infant on the mother's abdomen and about 20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times by the obstetrical provider or by a second team member at the rate of 20 cm/2 sec. This procedure can be done in 15-20 seconds. Length of 20 cm can be estimated by the length of a sponge holding forceps which is approximately 25 cm. The umbilical cord will then clamped 2 -3 cm from the umbilical stump. Immediate cord clamping: This will occur by clamping the umbilical cord as soon as possible (average 30 seconds). Further resuscitation will be done in accordance with NRP 2015 guidelines. Stop watch will be used to calculate the duration after which the cord is clamped and cut, time to first breath, and time required to achieve HR \> 100/min
Interventions
PROCEDUREUmbilical cord milking
20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times. The entire procedure can be done in 15-20 seconds
PROCEDUREImmediate cord clamping
clamping the umbilical cord as soon as possible (average 30 seconds)
Sponsors
Lady Hardinge Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
37 Weeks to 41 Weeks
Healthy volunteers
No
Inclusion criteria
Vaginally born, Singleton Term gestation (≥ 37 and & \< 42 weeks), requiring resuscitation at birth
Exclusion criteria
* Major congenital anomaly (antenatally diagnosed or visible at birth) * Rh negative pregnancy * Hydrops * Abruptio Placneta/ Placenta previa * Fetus with absent and reversal of End Diastolic flow * Cord avulsion * Refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hypoxic Ischemic Encephalopathy | From date of birth until date of death from any cause whichever come first assessed till 1 week of life | any stage as per Sarnat and Sarnat Staging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion requiring NICU admission | Till 1 week of life | NICU admission due to any reason |
| Level of hypoxic ischemic encephalopathy ( mild, moderate or severe) | From date of birth until date of death from any cause whichever come first assessed till 1 week of life | Level of hypoxic ischemic encephalopathy as per Sarnat and Sarnat Staging |
| Received blood products or saline bolus or inotropes to support blood pressure | From date of birth until date of death from any cause whichever come first assessed till 1 week of life | Hypotension requiring blood products or saline bolus or inotropes |
| Length of hospital stay | From date of birth until date of death from any cause whichever come first assessed till 4 week of life | Duration of stay in days |
| Mean Blood Pressure at 2,6,12,24,48,72 hrs | From date of birth until date of death from any cause whichever come first assessed till 72 hours of life | Mean Blood Pressure as assessed by non-invasive oscillometric method |
| Hyperbilirubinemia requiring phototherapy | From date of birth until date of death from any cause whichever come first assessed till 4 week of life | As per AAP charts |
| Proportion of neonates having APGAR score < 4 at 5 minutes of life | Till 5 minutes of life | APGAR score (Min zero maximum Ten) assessed at 1,5 minutes (Low APGAR is bad prognosis and High APGAR is good prognosis) |
| Neonates requiring Initial steps of resuscitation, Bag and Mask Ventilation, Intubation, chest compression and administration of drugs during resuscitation. | Till 1 minutes of life | As per NRP 2015 guidelines |
| Proportion of neonates developing polycythemia | Till first 72 hours | Polycythemia is defined as venous hematocrit \>65% |
| Proportion of mortality due to any cause | From date of birth until date of death from any cause whichever come first assessed till 4 week of life | Including early and late neonatal deaths |
Countries
India
Outcome results
None listed