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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
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
clamping the umbilical cord as soon as possible (average 30 seconds)
Lady Hardinge Medical college
New Delhi, National Capital Territory of Delhi, India
Incidence of Hypoxic Ischemic Encephalopathy
any stage as per Sarnat and Sarnat Staging
Time frame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Proportion requiring NICU admission
NICU admission due to any reason
Time frame: Till 1 week of life
Level of hypoxic ischemic encephalopathy ( mild, moderate or severe)
Level of hypoxic ischemic encephalopathy as per Sarnat and Sarnat Staging
Time frame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Received blood products or saline bolus or inotropes to support blood pressure
Hypotension requiring blood products or saline bolus or inotropes
Time frame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Length of hospital stay
Duration of stay in days
Time frame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
Mean Blood Pressure at 2,6,12,24,48,72 hrs
Mean Blood Pressure as assessed by non-invasive oscillometric method
Time frame: From date of birth until date of death from any cause whichever come first assessed till 72 hours of life
Hyperbilirubinemia requiring phototherapy
As per AAP charts
Time frame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
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Proportion of neonates having APGAR score < 4 at 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)
Time frame: Till 5 minutes of life
Neonates requiring Initial steps of resuscitation, Bag and Mask Ventilation, Intubation, chest compression and administration of drugs during resuscitation.
As per NRP 2015 guidelines
Time frame: Till 1 minutes of life
Proportion of neonates developing polycythemia
Polycythemia is defined as venous hematocrit \>65%
Time frame: Till first 72 hours
Proportion of mortality due to any cause
Including early and late neonatal deaths
Time frame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life