Clinical trial NCT06090968: Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation
Official title: Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation - A RANDOMIZED CONTROL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxic-Ischemic Encephalopathy
Perinatal Asphyxia
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2023-10-19
Enrollment: 200
Sex: ALL
Minimum age (years): 37
Maximum age (years): 41
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Hypoxic Ischemic Encephalopathy
timeFrame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
Secondary outcomes:
measure: Proportion requiring NICU admission
timeFrame: Till 1 week of life
measure: Level of hypoxic ischemic encephalopathy ( mild, moderate or severe)
timeFrame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
measure: Received blood products or saline bolus or inotropes to support blood pressure
timeFrame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
measure: Length of hospital stay
timeFrame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
measure: Mean Blood Pressure at 2,6,12,24,48,72 hrs
timeFrame: From date of birth until date of death from any cause whichever come first assessed till 72 hours of life
measure: Hyperbilirubinemia requiring phototherapy
timeFrame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
measure: Proportion of neonates having APGAR score < 4 at 5 minutes of life
timeFrame: Till 5 minutes of life
measure: Neonates requiring Initial steps of resuscitation, Bag and Mask Ventilation, Intubation, chest compression and administration of drugs during resuscitation.
timeFrame: Till 1 minutes of life
measure: Proportion of neonates developing polycythemia
timeFrame: Till first 72 hours
measure: Proportion of mortality due to any cause
timeFrame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Lady Hardinge Medical college
state: Delhi
Study officials:
affiliation: Lady Hardinge Medical College, New Delhi, India
name: Sushma Nangia, DM (Neo)
role: STUDY_CHAIR
References: