Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants
- Conditions
- PreTerm BirthIntraventricular Hemorrhage
- Interventions
- Other: Umbilical cord milking
- Registration Number
- NCT02996799
- Lead Sponsor
- King Abdulaziz University
- Brief Summary
For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.
- Detailed Description
Contrary to delayed cord clamping, milking of the umbilical cord is done at a faster rate and in shorter time.Recent evidence has demonstrated the efficacy and safety of umbilical cord milking for both term and preterm infants.A newer evidence comparing delayed cord clamping to umbilical cord milking in preterm infants demonstrated a higher initial hemoglobin, blood pressure and systemic blood flow in preterm infants allocated to the umbilical cord milking arm.However, concerns have been raised with regard to rapid infusion of large volume of blood in relatively shorter time predisposing to hyperperfusion injury including intraventricular hemorrhage. This is particularly problematic for preterm neonates as they are at higher risk of neurological injury. It has, though, advantage of shorter timeframe allowing for effective resuscitation of preterm neonates to start as soon as possible. Thus, with countering advantages and disadvantages, the practice has not been adopted at most places. The authors planned to conduct a randomized clinical trail to compare the efficacy and safety of umbilical cord milking to deferred cord clamping in preterm infants less than 32 weeks gestation.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- Preterm infants < 32 weeks gestation confirmed by first trimester US
- Any proven or suspected congenital or chromosomal abnormalities
- Placenta previa or abruption
- Cord prolapse
- Known Rh sensitization
- Fetal hydrops
- Monochorionic multiples
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Umbilical cord milking Umbilical cord milking Manually stripping 20cm of cord segment toward the umbilicus over a period of 2-3 seconds three times before cord clamping.
- Primary Outcome Measures
Name Time Method Intraventricular haemorrhage twenty eight days Any IVH diagnosed by cranial ultrasound
- Secondary Outcome Measures
Name Time Method Mortality in hospital one month Death before discharge
Need for resuscitation one hour Cardiac compression or medications at birth
Apgar score at one minute one minute after delivery Calculated Apgar score at one minute
Apgar score at 5 minutes 5 minutes after delivery Calculated Apgar score at 5 minutes
The need for blood transfusion during hospital stay one month The number of blood transfusions during hospital stay
Venous Hgb 2 days Hgb at birth
Venous hematocrit 2 days Hematocrit at birth
Bilirubin level 24 hours after birth First bilirubin level after birth
Sepsis one month Positive blood culture
Polycythemia first 48 hours after birth If venous hematocrit more than 65%
Respiratory distress syndrome 48 hours after birth The need for surfactant administration
Oxygen dependency first 28 days after birth and 36 weeks corrected age first 28 days after birth and/or 36 weeks corrected age
Need for volume administration 24 hours after birth Need for bolus administration first 24 hours after birth
Use of inotropes First 24 hours Use of any kind of inotropes in the first 24 hours
Necrotizing enterocolitis one month Bell stage II or more
Maximum bilirubin level first week of life Highest bilirubin level
Maternal mortality 2 weeks Maternal death after delivery in hospital
Post partum hemorrhage one day Maternal estimated blood loss more than 500 mls in the first 24 hours after birth
Maternal need for blood transfusion First 48 hours after delivery Maternal blood transfusion in the first 48 hours after delivery
Length of third stage 24 hours The time from delivery of the infant until delivery of placenta
Trial Locations
- Locations (1)
King Abdulaziz University Hospital
🇸🇦Jeddah, Saudi Arabia