An interventional study of Umbilical Cord Milking and Delayed Cord Clamping in Intraventricular Hemorrhage, sponsored by Sharp HealthCare. Completed at 3 sites in United States. Per ClinicalTrials.gov, last updated 2018-05-24.
Sponsored by Sharp HealthCare · Not applicable, Interventional, and Prevention
Premature babies can be very sick and have bleeding in the brain. Giving babies more blood before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion to the brain. However, some studies suggest that delayed cord clamping may not increase hemoglobin or blood volume in babies delivered by cesarean section. Milking the umbilical cord may give more blood in babies delivered by Cesarean Section may improve perfusion and reduce bleeding in the brain.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 197 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Sharp HealthCare is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Milking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds
Procedure: Umbilical Cord Milking
Delayed clamping of the umbilical cord for 45-60 seconds
Procedure: Delayed Cord Clamping
Umbilical cord milked toward the neonate four times at a speed of 20cm/2seconds, prior to clamping and cutting umbilical cord. Procedure takes about 10-20 seconds.
Performed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting.
Superior Vena Cava Flow
Time frame: <12 hours of life
Delivery Room Interventions
Time frame: 10 minutes of life
Hemoglobin
Time frame: <1 hour
Hemoglobin
Time frame: 12 hours
Hemoglobin
Time frame: 4 weeks of life
Neurodevelopmental impairment 18-36 months
Time frame: 18-36 months
Severe intraventricular hemorrhage (grade 3 or 4)
Time frame: up to 24 weeks after birth
Phototherapy
Requirement and length of phototherapy
Time frame: up to 24 weeks after birth
Ionotropic support
Requirement and length of ionotropic support
Time frame: up to 24 weeks after birth
Neonatal intensive care unit (NICU) length of stay
Time frame: up to 24 weeks after birth
Necrotizing enterocolitis
Time frame: up to 24 weeks after birth
Number of blood transfusions while in the neonatal intensive care unit
Time frame: up to 24 weeks after birth
Ventilator time
Time frame: up to 24 weeks after birth
Apgar score <7 at 5 minutes
Time frame: at 5 minutes after birth
Umbilical cord pH < 7.0
Time frame: up to 30 minutes after birth
Blood pressure in first 2 hours of admission to neonatal intensive care unit
Time frame: 2 hours after birth
Polycythemia
Time frame: up to 24 hours of life
Neonatal death
Time frame: up to 24 weeks of life
Use of uterotonic agents
Time frame: up to 1 hour after birth
Peak transcutaneous and/or serum bilirubin concentrations
Time frame: up to 24 weeks after birt
Maternal hemoglobin
Time frame: within 48 hours after delivery
Intraventricular Hemorrhage detected on Head Ultrasound
Time frame: up to 24 weeks after birth
Days on Oxygen
Time frame: during hospitalization
Vaginal Delivered infants (no difference in interventions)
Time frame: up to 24 weeks after birth
Cerebral Tissue Oxygenation
Time frame: Up to 24 hours of life
Cardiac output by electric cardiometry
Time frame: up to 24 hours of life
Stroke volume by electric cardiometry
Time frame: Up to 24 hours of life
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sharp HealthCare