An interventional study of Umbilical cord milking and Immediate cord clamping in Hypoxic-Ischemic Encephalopathy and Perinatal Asphyxia, sponsored by Lady Hardinge Medical College. Completed at 1 site in India. Open to participants aged 37 Weeks to 41 Weeks. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Lady Hardinge Medical College · Not applicable, Interventional, and Prevention
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
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 95 are open to participants now.
This study's enrollment of 200 is above the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Lady Hardinge Medical College is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Vaginally born, Singleton Term gestation (≥ 37 and \& \< 42 weeks), requiring resuscitation at birth
Exclusion Criteria:
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
Procedure: Umbilical cord milking
clamping the umbilical cord as soon as possible (average 30 seconds)
Procedure: Immediate cord clamping
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)
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
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
Ran from Feb 2022 to primary completion in Feb 2024, 23 months.
Of 46 non-industry interventional studies with no phase under Hypoxia-Ischemia, Brain, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 63. This study's 23 months is below that.
Counting every sponsor, half of 47 studies reached it within 33 months; a quarter within 19 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lady Hardinge Medical College