Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical cord milking | Experimental | 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 |
|
| Immediate cord clamping | Active Comparator | clamping the umbilical cord as soon as possible (average 30 seconds) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord milking | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hypoxic Ischemic Encephalopathy | any stage as per Sarnat and Sarnat Staging | From date of birth until date of death from any cause whichever come first assessed till 1 week of life |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion requiring NICU admission | NICU admission due to any reason | 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 |
Not provided
Inclusion Criteria:
Vaginally born, Singleton Term gestation (≥ 37 and & < 42 weeks), requiring resuscitation at birth
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sushma Nangia, DM (Neo) | Lady Hardinge Medical College, New Delhi, India | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lady Hardinge Medical college | New Delhi | National Capital Territory of Delhi | 110001 | India |
Not provided
| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Immediate cord clamping | Procedure | clamping the umbilical cord as soon as possible (average 30 seconds) |
|
| 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 | 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 | 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 | 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 | From date of birth until date of death from any cause whichever come first assessed till 4 week of life |
| 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) | 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 | Till 1 minutes of life |
| Proportion of neonates developing polycythemia | Polycythemia is defined as venous hematocrit >65% | Till first 72 hours |
| Proportion of mortality due to any cause | Including early and late neonatal deaths | From date of birth until date of death from any cause whichever come first assessed till 4 week of life |
| 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 |