Milking the Umbilical Cord for Extreme Preterm Infants

Infant, Extremely Premature Clinical Trial

Official title:

Milking the Umbilical Cord for Extreme Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666847
• Other study ID #: 21429
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: July 2017

Study information

• Verified date: August 2019
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown to improve heart and lung function, reduces the need for blood transfusion, and reduces the risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical cord, however in extremely premature infants is not considered safe, since it also delays the resuscitation that these infants need immediately after birth. Milking the umbilical cord is believed have similar benefits to delaying the clamping of the cord, but can be done much faster (seconds rather than minutes). In this study, the cord will milked three times over about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for routine care. Participants of this study will be randomly assigned to one of two study groups: the first group will have the cord milking intervention and the second group will not have any intervention other than routine, immediate cord clamping with routine care of mother and infant. Data will be collected about the mother prior to delivery and data will also be collected about the baby using computerized health records. The data will look at short term changes in red blood cell volumes, the need for blood transfusions, and rates of known complications of prematurity, including longer term developmental complications at 18-24 months.

The hypothesis is that milking the umbilical cord before cutting the cord will lead to a higher hemoglobin concentration and decrease the need for blood transfusions in extremely preterm neonates compared to the current standard of immediately clamping the umbilical cord.

Description:

Eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do not have congenital anomalies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pregnant women/child pairs with infants born at an estimated gestation age between 24 0/7 and 27 6/7 weeks based on best estimate made by last menstrual period or ultrasound

• informed consent obtained by the pregnant women prior to delivery of the infant.

Exclusion Criteria:

• pregnancy with a multiple gestation

• infants with pre- or postnatally diagnosed major congenital anomalies or probable chromosomal abnormalities

• infants with hydrops fetalis

Related Conditions & MeSH terms

• Infant, Extremely Premature

Intervention

Procedure:
• Milking the umbilical cord before cord clamping
The procedure will involve positioning the neonate below the level of the placenta and milking approximately 20cm of umbilical cord three times over 10-20 seconds total from the placental end to the neonate. The cord will then be clamped and the neonate handed to the awaiting medical team for routine care of a premature infant.

Locations

Country	Name	City	State
United States	Saint Louis University, Division of Neonatology, SSM Cardinal Glennon Children's Medical Center	Saint Louis	Missouri
United States	Saint Louis University, Division of Neonatology, SSM St. Mary's Health Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Hosono S, Mugishima H, Fujita H, Hosono A, Minato M, Okada T, Takahashi S, Harada K. Umbilical cord milking reduces the need for red cell transfusions and improves neonatal adaptation in infants born at less than 29 weeks' gestation: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2008 Jan;93(1):F14-9. Epub 2007 Jan 18. — View Citation

Leavitt BG, Huff DL, Bell LA, Thurnau GR. Placental drainage of fetal blood at cesarean delivery and feto maternal transfusion: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):608-11. — View Citation

Rabe H, Jewison A, Alvarez RF, Crook D, Stilton D, Bradley R, Holden D; Brighton Perinatal Study Group. Milking compared with delayed cord clamping to increase placental transfusion in preterm neonates: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):205-11. doi: 10.1097/AOG.0b013e3181fe46ff. — View Citation

Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93(2):138-44. Epub 2007 Sep 21. Review. — View Citation

Rabe H, Reynolds G, Diaz-Rossello J. Early versus delayed umbilical cord clamping in preterm infants. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003248. Review. Update in: Cochrane Database Syst Rev. 2012;8:CD003248. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate and compare hemoglobin and hematocrit concentrations in extremely low birth weight infants (ELVW) after cord milking intervention to ELBW infants receiving immediate cord clamping		Within 4 hour of birth
Primary	To evaluate and compare the incidence and numbers of blood transfusions after cord milking		Prior to initial infant discharge
Secondary	To evaluate and compare blood pressure after intervention and need for support medications		For first seven days of life
Secondary	To evaluate and compare the incidence of hyperbilirubinemia and length of phototherapy	Highest bilirubin or maximum at 120 hours of life, plus total days of phototherapy.	Three weeks
Secondary	To evaluate the incidence of complications of prematurity in the study and control groups		Until 3 years corrected gestational age
Secondary	To evaluate long term outcomes of prematurity in both groups in a follow-up study		Until 3 years corrected gestational age
Secondary	To compare the difference in hemoglobin and hematocrit from umbilical cord blood		Within 4 hours of birth