Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm (CORDMILK-PT)

April 8, 2024 updated by: Zubair Aghai, Nemours Children's Clinic

A Cluster Randomized Clinical Trial of Umbilical Cord Milking Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth

The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Prematurity is the leading cause of death in children younger than 5 years of age. Worldwide, 15 million infants are born premature, and India alone contributes to quarter of them. Approximately 1 million children die each year due to complications of prematurity.

Delayed cord clamping (DCC), one of the methods of transfer of placental blood to neonates (placental transfusion) immediately after birth reduce mortality by 30% in premature infants. But DCC is not recommended in neonates who require immediate resuscitation. Umbilical cord milking (UCM) is an option for placental transfusion in preterm infants who require immediate resuscitation but not currently recommended due to lack of randomized clinical trials.

HYPOTHESIS: UCM will reduce the in-hospital mortality in non-vigorous preterm infants born between 30 weeks to 34 weeks of gestation compared to early cord clamping.

METHODS: This multicenter cluster crossover randomized trial will enroll approximately 800 preterm infants to early cord clamping or milking the intact cord 4 times prior to clamping.

IMPACT: If investigators find that UCM is beneficial, this simple, low-tech, no cost intervention can be used in preventing deaths in preterm infants. This trial will potentially provide evidence to support a change in guidelines making UCM part of standard practice worldwide for preterm infants who require immediate resuscitation.

Study Type

Interventional

Enrollment (Estimated)

800

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 Locations

  • India
    • Karnataka
      • Belgaum, Karnataka, India, 590010
        • KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
        • Contact:
        • Sub-Investigator:
          • Shivaprasad Goudar, MD
    • MS
      • Nagpur, MS, India, 440002
        • Daga Memorial Woman and Children Hospital
        • Contact:
        • Principal Investigator:
          • Vineeta Jain, MD
        • Principal Investigator:
          • Seema Parvekar, MD
      • Nagpur, MS, India, 440009
        • Government Medical College and Hospital
        • Principal Investigator:
          • Manoj Bhatnagar, MD
        • Principal Investigator:
          • Manjushri Waikar, MD
        • Contact:
        • Sub-Investigator:
          • Nidhi Nashine
      • Wardha, MS, India, 442102
        • Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
        • Contact:
        • Principal Investigator:
          • Shuchi Jain, MD
        • Principal Investigator:
          • Manish Jain, MD
    • Maharashtra
      • Chandrapur, Maharashtra, India, 442401
        • Government Medical College
        • Contact:
        • Principal Investigator:
          • Milind Kamble, MD
        • Principal Investigator:
          • Deepti Shrirame, MD
      • Nagpur, Maharashtra, India, 440018
        • Indira Gandhi Government Medical College & Hospital
        • Principal Investigator:
          • Milind Suryavanshi, MD
        • Principal Investigator:
          • Alka Patankar, MD
        • Contact:
      • Pune, Maharashtra, India, 411018
        • Yashwantrao Chavan Memorial Hospital
        • Principal Investigator:
          • Deepali Ambike, MD
        • Principal Investigator:
          • Mahesh Asalkar, MD
        • Contact:
        • Sub-Investigator:
          • Rajesh Kulkarni, MD
        • Sub-Investigator:
          • Hemraj Narkheded, MD
        • Sub-Investigator:
          • Sandhya Haribhakta, MD
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Sawai Man Singh Medical College

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:

  • Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
  • Non-vigorous at birth

Exclusion Criteria:

  • Infants with congenital malformation
  • Major chromosomal abnormalities
  • Complete placental abruption/cutting through the placenta at the time of delivery
  • Cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord)
  • Mono-chorionic twins,
  • Twins with no information on amnion/chorion
  • Multiple gestation >2

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Early Cord Clamping
Umbilical cord will be clamped immediately after birth (within 60 seconds)
Active Comparator: Umbilical Cord Milking
The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for early cord clamping (ECC).
Procedure: Umbilical cord milking
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 1--15 seconds.
Other Names:
  • UCM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, assessed up to 12 weeks
Death of a baby during birth hospitalization
From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, assessed up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin at or after 24 hours
Time Frame: Days 1-7
Hb levels
Days 1-7
Early and late onset culture positive sepsis
Time Frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Number of infants with early onset or late onset sepsis
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Any intraventricular hemorrhage (IVH) and severe IVH (grade 3 or 4)
Time Frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Number of infants with any IVH or severe IVH
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Need for blood transfusion
Time Frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Number of infants received blood transfusion
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Moderate to severe hypoxemic ischemic encephalopathy
Time Frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Number of infants with moderate to severe hypoxemic ischemic encephalopathy
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Necrotizing enterocolitis (Bell's stage 2 or higher)
Time Frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Number of infants with necrotizing enterocolitis (Bell's stage 2 or higher)
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Need for medications for hypotension
Time Frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Number of infants needed medications for hypotension
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Need for phototherapy for jaundice
Time Frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Number of infants needed phototherapy for jaundice
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Retinopathy of prematurity (ROP) requiring intervention
Time Frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Number of infants with ROP that required intervention
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Length of hospitalization
Time Frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Number of days infants stayed in hospital
From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

Collaborators and Investigators

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

Sponsor

Nemours Children's Clinic

Collaborators

Thomas Jefferson University
Thrasher Research Fund
Jawaharlal Nehru Medical College
Sharp HealthCare
Daga Memorial Maternity and Children's Hospital, Nagpur, India
Indira Gandhi Government Medical College & Hospital, Nagpur, India
Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India
Government Medical College, Nagpur
Mahatma Gandhi Institute of Medical Sciences, Wardha, India
Government Medical College, Chandrapur, 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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

May 28, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORDMILK-PT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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