Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm

Preterm Clinical Trial

— CORDMILK-PT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06240715
• Other study ID #: CORDMILK-PT
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: June 2024
• Source: Nemours Children's Clinic
• Contact: Zubair H Aghai, MD
• Phone: 215 955 6523
• Email: zaghai[@]nemours.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Minutes to 10 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Infant Death
• Premature Birth
• Preterm

Intervention

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.

Locations

Country	Name	City	State
India	KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College	Belgaum	Karnataka
India	Government Medical College	Chandrapur	Maharashtra
India	Sawai Man Singh Medical College	Jaipur	Rajasthan
India	Daga Memorial Woman and Children Hospital	Nagpur	MS
India	Government Medical College and Hospital	Nagpur	MS
India	Indira Gandhi Government Medical College & Hospital	Nagpur	Maharashtra
India	Yashwantrao Chavan Memorial Hospital	Pune	Maharashtra
India	Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital	Wardha	MS

Sponsors (11)

Lead Sponsor

Collaborator

Nemours Children's Clinic

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

Country where clinical trial is conducted

India, 

Outcome

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