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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
800
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.
KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
Belagavi, Karnataka, India
NOT_YET_RECRUITINGGovernment Medical College
Chandrapur, Maharashtra, India
NOT_YET_RECRUITINGIn-hospital mortality
Death of a baby during birth hospitalization
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
Hemoglobin at or after 24 hours
Hb levels
Time frame: Days 1-7
Early and late onset culture positive sepsis
Number of infants with early onset or late onset sepsis
Time frame: 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)
Number of infants with any IVH or severe IVH
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Need for blood transfusion
Number of infants received blood transfusion
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Moderate to severe hypoxemic ischemic encephalopathy
Number of infants with 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.
Necrotizing enterocolitis (Bell's stage 2 or higher)
Number of infants with 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.
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Indira Gandhi Government Medical College & Hospital
Nagpur, Maharashtra, India
Yashwantrao Chavan Memorial Hospital
Pune, Maharashtra, India
NOT_YET_RECRUITINGDaga Memorial Woman and Children Hospital
Nagpur, MS, India
RECRUITINGGovernment Medical College and Hospital
Nagpur, MS, India
NOT_YET_RECRUITINGMahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
Wardha, MS, India
NOT_YET_RECRUITINGSawai Man Singh Medical College
Jaipur, Rajasthan, India
RECRUITINGOsmania Medical College, Niloufer Hospital
Hyderabad, Telangana, India
RECRUITINGNeed for medications for hypotension
Number of infants needed medications for hypotension
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Need for phototherapy for jaundice
Number of infants needed phototherapy for jaundice
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Retinopathy of prematurity (ROP) requiring intervention
Number of infants with ROP that required intervention
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.
Length of hospitalization
Number of days infants stayed in hospital
Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.