Milking the Umbilical Cord for Extreme Preterm Infants

Not Applicable

Completed

• Conditions: Infant, Extremely Premature
• Interventions: Procedure: Milking the umbilical cord before cord clamping

• Registration Number: NCT01666847
• Lead Sponsor: St. Louis University

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-16
• Study Start: 2012-10
• Primary Completion: 2016-08
• Study Completion: 2017-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-11
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cord Milking	Milking the umbilical cord before cord clamping	Infant receiving cord milking intervention before umbilical cord clamped.

Primary Outcome Measures

Name	Time	Method
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
To evaluate and compare the incidence and numbers of blood transfusions after cord milking	Prior to initial infant discharge

Secondary Outcome Measures

Name	Time	Method
To evaluate long term outcomes of prematurity in both groups in a follow-up study	Until 3 years corrected gestational age
To compare the difference in hemoglobin and hematocrit from umbilical cord blood	Within 4 hours of birth
To evaluate and compare blood pressure after intervention and need for support medications	For first seven days of life
To evaluate and compare the incidence of hyperbilirubinemia and length of phototherapy	Three weeks	Highest bilirubin or maximum at 120 hours of life, plus total days of phototherapy.
To evaluate the incidence of complications of prematurity in the study and control groups	Until 3 years corrected gestational age

Trial Locations

Locations (2)

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, United States