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

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.

• Hemoglobin at or after 24 hours [Time frame: Days 1-7]
• Early and late onset culture positive 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) [Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.]
• Need for 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 [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) [Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.]
• Need for 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 [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 [Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.]
• Length of hospitalization [Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.]