Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

PreTerm Birth Clinical Trial

Official title:

Efficacy and Safety of Deferred Umbilical Cord Clamping Compared to Umbilical CordMilking in Preterm Infants: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02996799
• Other study ID #: 409-16
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 2023

Study information

• Verified date: September 2021
• Source: King Abdulaziz University
• Contact: Heidi Al-Wassia
• Phone: 966544800441
• Email: halwassia[@]kau.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intraventricular Hemorrhage
• Premature Birth
• PreTerm Birth

Intervention

Other:
• Umbilical cord milking
Milking of the umbilical cord at delivery

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University Hospital	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraventricular haemorrhage	Any IVH diagnosed by cranial ultrasound	twenty eight days
Secondary	Need for resuscitation	Cardiac compression or medications at birth	one hour
Secondary	Apgar score at one minute	Calculated Apgar score at one minute	one minute after delivery
Secondary	Apgar score at 5 minutes	Calculated Apgar score at 5 minutes	5 minutes after delivery
Secondary	The need for blood transfusion during hospital stay	The number of blood transfusions during hospital stay	one month
Secondary	Venous Hgb	Hgb at birth	2 days
Secondary	Venous hematocrit	Hematocrit at birth	2 days
Secondary	Bilirubin level	First bilirubin level after birth	24 hours after birth
Secondary	Maximum bilirubin level	Highest bilirubin level	first week of life
Secondary	Polycythemia	If venous hematocrit more than 65%	first 48 hours after birth
Secondary	Respiratory distress syndrome	The need for surfactant administration	48 hours after birth
Secondary	Oxygen dependency	first 28 days after birth and/or 36 weeks corrected age	first 28 days after birth and 36 weeks corrected age
Secondary	Need for volume administration	Need for bolus administration first 24 hours after birth	24 hours after birth
Secondary	Use of inotropes	Use of any kind of inotropes in the first 24 hours	First 24 hours
Secondary	Necrotizing enterocolitis	Bell stage II or more	one month
Secondary	Mortality in hospital	Death before discharge	one month
Secondary	Sepsis	Positive blood culture	one month
Secondary	Maternal mortality	Maternal death after delivery in hospital	2 weeks
Secondary	Post partum hemorrhage	Maternal estimated blood loss more than 500 mls in the first 24 hours after birth	one day
Secondary	Maternal need for blood transfusion	Maternal blood transfusion in the first 48 hours after delivery	First 48 hours after delivery
Secondary	Length of third stage	The time from delivery of the infant until delivery of placenta	24 hours