Clinical trial NCT02996799: Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants
Official title: Efficacy and Safety of Deferred Umbilical Cord Clamping Compared to Umbilical CordMilking in Preterm Infants: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreTerm Birth
Intraventricular Hemorrhage
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Preterm infants \< 32 weeks gestation confirmed by first trimester US

Exclusion Criteria:

* Any proven or suspected congenital or chromosomal abnormalities
* Placenta previa or abruption
* Cord prolapse
* Known Rh sensitization
* Fetal hydrops
* Monochorionic multiples

Primary outcomes:
measure: Intraventricular haemorrhage
timeFrame: twenty eight days
Secondary outcomes:
measure: Need for resuscitation
timeFrame: one hour
measure: Apgar score at one minute
timeFrame: one minute after delivery
measure: Apgar score at 5 minutes
timeFrame: 5 minutes after delivery
measure: The need for blood transfusion during hospital stay
timeFrame: one month
measure: Venous Hgb
timeFrame: 2 days
measure: Venous hematocrit
timeFrame: 2 days
measure: Bilirubin level
timeFrame: 24 hours after birth
measure: Maximum bilirubin level
timeFrame: first week of life
measure: Polycythemia
timeFrame: first 48 hours after birth
measure: Respiratory distress syndrome
timeFrame: 48 hours after birth
measure: Oxygen dependency
timeFrame: first 28 days after birth and 36 weeks corrected age
measure: Need for volume administration
timeFrame: 24 hours after birth
measure: Use of inotropes
timeFrame: First 24 hours
measure: Necrotizing enterocolitis
timeFrame: one month
measure: Mortality in hospital
timeFrame: one month
measure: Sepsis
timeFrame: one month
measure: Maternal mortality
timeFrame: 2 weeks
measure: Post partum hemorrhage
timeFrame: one day
measure: Maternal need for blood transfusion
timeFrame: First 48 hours after delivery
measure: Length of third stage
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital
Study officials:
affiliation: King Abdulaziz University
name: Heidi Al-Wassia, MD
role: PRINCIPAL_INVESTIGATOR
References: