Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:

Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation - A RANDOMIZED CONTROL TRIAL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090968
• Other study ID #: LHMC/IEC/071/UCM
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2022
• Est. completion date: February 4, 2024

Study information

• Verified date: October 2023
• Source: Lady Hardinge Medical College
• Contact: Sushma Nangia, DM (Neo)
• Phone: 9810838181
• Email: drsnangia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 4, 2024
• Est. primary completion date: December 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 37 Weeks to 41 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Perinatal Asphyxia

Intervention

Procedure:
• Umbilical 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
• Immediate cord clamping
clamping the umbilical cord as soon as possible (average 30 seconds)

Locations

Country	Name	City	State
India	Lady Hardinge Medical college	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Proportion requiring NICU admission	NICU admission due to any reason	Till 1 week of life
Secondary	Level of hypoxic ischemic encephalopathy ( mild, moderate or severe)	Level of hypoxic ischemic encephalopathy 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of neonates developing polycythemia	Polycythemia is defined as venous hematocrit >65%	Till first 72 hours
Secondary	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