Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks

Prematurity Clinical Trial

Official title:

Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants <33 Weeks: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01819532
• Other study ID #: NA_00046760
• Status: Terminated
• Phase: N/A
• First received: October 6, 2011
• Last updated: December 7, 2017
• Start date: September 2011
• Est. completion date: October 2013

Study information

• Verified date: December 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

• Preterm neonates delivered between 24 0/7 and 32 6/7

• Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age

• Written parental consent

Exclusion Criteria:

• Multiple gestation pregnancies (twins or higher order multiples)

• Rh or other antibody sensitization

• Hydrops fetalis

• Known major congenital abnormality

• Suspected abruptio placentae

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Procedure:
• Milking group
The umbilical cord will be "milked" toward the neonate four times prior to clamping the umbilical cord.
• Immediate cord clamping
The umbilical cord will be clamped and cut immediately after delivery of the neonate.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin during NICU course		within 24 hours of birth and through NICU stay
Secondary	1-min Apgar		at 1 minute of life
Secondary	5 min Apgar		at 5 minutes of life
Secondary	Blood Sugar upon admission to NICU		within 1 hour of birth
Secondary	Temperature on admission to NICU		within 1 hour of birth
Secondary	Cord blood pH		within 1 hour of birth
Secondary	Blood pressure upon admission to NICU		within 1 hour of birth
Secondary	Number of volume challenges in first 24 hours of life		at 24 hours of birth
Secondary	Days requiring ventilation		2 months
Secondary	Neonatal death		6 months
Secondary	Length of hospital stay		6 months
Secondary	Intraventricular hemorrhage		6 months
Secondary	Number and volume of blood transfusions		10 units
Secondary	duration of phototherapy		1 month
Secondary	Maximum serum bilirubin		1 month