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

October 19, 2023 updated by: Sushma Nangia, M.D., Lady Hardinge Medical College

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110001
        • Recruiting
        • Lady Hardinge Medical College
        • Contact:
        • Contact:
          • Tapas Bandyopadhyay, DM (Neo)
          • Phone Number: 9910371315
        • Principal Investigator:
          • Sushma Nangia, DM (Neo)
        • Sub-Investigator:
          • Gunjana Kumar, DM (Neo)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Active Comparator: Immediate cord clamping
clamping the umbilical cord as soon as possible (average 30 seconds)
Procedure: Immediate cord clamping
clamping the umbilical cord as soon as possible (average 30 seconds)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Hypoxic Ischemic Encephalopathy
Time Frame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion requiring NICU admission
Time Frame: Till 1 week of life
NICU admission due to any reason
Till 1 week of life
Level of hypoxic ischemic encephalopathy ( mild, moderate or severe)
Time Frame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
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
Received blood products or saline bolus or inotropes to support blood pressure
Time Frame: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
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
Time Frame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
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
Time Frame: From date of birth until date of death from any cause whichever come first assessed till 72 hours of life
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
Time Frame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
As per AAP charts
From date of birth until date of death from any cause whichever come first assessed till 4 week of life
Neonates requiring Initial steps of resuscitation, Bag and Mask Ventilation, Intubation, chest compression and administration of drugs during resuscitation.
Time Frame: Till 1 minutes of life
As per NRP 2015 guidelines
Till 1 minutes of life
Proportion of neonates developing polycythemia
Time Frame: Till first 72 hours
Polycythemia is defined as venous hematocrit >65%
Till first 72 hours
Proportion of mortality due to any cause
Time Frame: From date of birth until date of death from any cause whichever come first assessed till 4 week of life
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
Proportion of neonates having APGAR score < 4 at 5 minutes of life
Time Frame: Till 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lady Hardinge Medical College

Investigators

  • Study Chair: Sushma Nangia, DM (Neo), Lady Hardinge Medical College, New Delhi, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2022

Primary Completion (Estimated)

December 4, 2023

Study Completion (Estimated)

February 4, 2024

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LHMC/IEC/071/UCM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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