NCT06240715

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Jul 2024Dec 2026

First Submitted

Initial submission to the registry

January 26, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

January 26, 2024

Last Update Submit

July 8, 2025

Conditions

PretermInfant Death

Keywords

PretermUmbilical cord milkingPlacental transfusion

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    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 Outcomes (10)

  • Hemoglobin at or after 24 hours

    Days 1-7

  • Early and late onset culture positive 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)

    From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

  • Need for 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

    From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

  • +5 more secondary outcomes

Study Arms (2)

Umbilical Cord Milking

ACTIVE COMPARATOR

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

Early Cord Clamping

NO INTERVENTION

Umbilical cord will be clamped immediately after birth (within 60 seconds)

Interventions

Umbilical cord milkingPROCEDURE

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.

Also known as: UCM
Umbilical Cord Milking

Eligibility Criteria

Age0 Minutes - 10 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College

Belagavi, Karnataka, 590010, India

NOT YET RECRUITING

Government Medical College

Chandrapur, Maharashtra, 442401, India

NOT YET RECRUITING

Indira Gandhi Government Medical College & Hospital

Nagpur, Maharashtra, 440018, India

NOT YET RECRUITING

Yashwantrao Chavan Memorial Hospital

Pune, Maharashtra, 411018, India

NOT YET RECRUITING

Daga Memorial Woman and Children Hospital

Nagpur, MS, 440002, India

RECRUITING

Government Medical College and Hospital

Nagpur, MS, 440009, India

NOT YET RECRUITING

Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital

Wardha, MS, 442102, India

NOT YET RECRUITING

Sawai Man Singh Medical College

Jaipur, Rajasthan, 302004, India

RECRUITING

Osmania Medical College, Niloufer Hospital

Hyderabad, Telangana, 500004, India

RECRUITING

MeSH Terms

Conditions

Premature BirthInfant DeathFetofetal Transfusion

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Zubair H Aghai, MD

CONTACT

215 955 6523zaghai@nemours.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Cluster Randomized Crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 5, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Locations

IN(9)