Clinical trial NCT06240715: Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm
Infant Death
Keywords: Preterm
Umbilical cord milking
Placental transfusion
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
name: Thomas Jefferson University
name: Sharp HealthCare
name: Jawaharlal Nehru Medical College
name: Daga Memorial Maternity and Children's Hospital, Nagpur, India
name: Mahatma Gandhi Institute of Medical Sciences, Wardha, India
name: Indira Gandhi Government Medical College & Hospital, Nagpur, India
name: Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India
name: Government Medical College, Nagpur
name: Government Medical College, Chandrapur, India
First posted: 2024-02-05
Enrollment: 800
Sex: ALL
Minimum age (years): 0
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster Randomized Crossover
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-hospital mortality
timeFrame: 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:
measure: Hemoglobin at or after 24 hours
timeFrame: Days 1-7
measure: Early and late onset culture positive sepsis
timeFrame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
measure: Any intraventricular hemorrhage (IVH) and severe IVH (grade 3 or 4)
timeFrame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
measure: Need for blood transfusion
timeFrame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
measure: Moderate to severe hypoxemic ischemic encephalopathy
timeFrame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
measure: Necrotizing enterocolitis (Bell's stage 2 or higher)
timeFrame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
measure: Need for medications for hypotension
timeFrame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
measure: Need for phototherapy for jaundice
timeFrame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
measure: Retinopathy of prematurity (ROP) requiring intervention
timeFrame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
measure: Length of hospitalization
timeFrame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Other outcomes:
Locations:
city: Belgaum
country: India
facility: KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
state: Karnataka
city: Chandrapur
country: India
facility: Government Medical College
state: Maharashtra
city: Nagpur
country: India
facility: Indira Gandhi Government Medical College & Hospital
state: Maharashtra
city: Pune
country: India
facility: Yashwantrao Chavan Memorial Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Daga Memorial Woman and Children Hospital
state: MS
city: Nagpur
country: India
facility: Government Medical College and Hospital
state: MS
city: Wardha
country: India
facility: Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
state: MS
city: Jaipur
country: India
facility: Sawai Man Singh Medical College
state: Rajasthan
Study officials:
References: