Study of squeezing blood from the umbilical cord to the premature baby before tying the cord

A Cluster Randomized clinical trial of umbilical cord milking compared to early cord clamping in preterm infants who are non-vigorous at birth - CORDMILK-PT

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061528

Enrollment

800

Registered

2024-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other] Health Condition 2: P289- Respiratory condition of newborn,unspecified

Interventions

Intervention1: Umbilical Cord Milking: The delivering obstetrician will place the newborn below the level of the incision (at the edge of the table) in Caesarean section and a second team member will

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants (30 0/7-34 6/7 weeks gestation) who are non-vigorous at birth that do not meet exclusion criteria will be included. If the infant is non-vigorous and needs immediate resuscitation as defined by the study (adopted from national guidelines), the baby will be included in the study.

Exclusion criteria

Exclusion criteria: Infants with congenital malformation of the central nervous system, chromosomal abnormalities, major congenital malformations, 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 or mother not able to provide consent will be excluded.

Design outcomes

Primary

Measure	Time frame
Mortality during birth hospitalizationTimepoint: From birth till discharge from hospital	—

Secondary

Measure	Time frame
Need for blood transfusionTimepoint: From birth till discharge from hospital;Moderate to severe hypoxemic ischemic encephalopathyTimepoint: From birth till discharge from hospital;Necrotizing enterocolitis (Bellâ??s stage 2 or higher)Timepoint: From birth till discharge from hospital;Need for medications for hypotensionTimepoint: From birth till discharge from hospital;Need for phototherapy for jaundiceTimepoint: From birth till discharge from hospital;Retinopathy of prematurity requiring interventionTimepoint: From birth till discharge from hospital;Length of hospitalizationTimepoint: From birth till discharge from hospital;Hemoglobin at 24 hoursTimepoint: 24 hours after birth;Early and late onset culture positive sepsisTimepoint: From birth till discharge from hospital;Any Intra ventricular Hemorrhage and severe Intra ventricular Hemorrhage (grade 3 or 4)Timepoint: From birth till discharge from hospital	—

Measure

Time frame

Need for blood transfusionTimepoint: From birth till discharge from hospital;Moderate to severe hypoxemic ischemic encephalopathyTimepoint: From birth till discharge from hospital;Necrotizing enterocolitis (Bellâ??s stage 2 or higher)Timepoint: From birth till discharge from hospital;Need for medications for hypotensionTimepoint: From birth till discharge from hospital;Need for phototherapy for jaundiceTimepoint: From birth till discharge from hospital;Retinopathy of prematurity requiring interventionTimepoint: From birth till discharge from hospital;Length of hospitalizationTimepoint: From birth till discharge from hospital;Hemoglobin at 24 hoursTimepoint: 24 hours after birth;Early and late onset culture positive sepsisTimepoint: From birth till discharge from hospital;Any Intra ventricular Hemorrhage and severe Intra ventricular Hemorrhage (grade 3 or 4)Timepoint: From birth till discharge from hospital

—

Countries

India

Contacts

Public ContactDr S M Dhaded

J N Medical College KAHER Belagavi

drdhadedsm@gmail.com9844232586

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026