Intraventricular Hemorrhage
Conditions
Keywords
umbilical cord milking, delayed cord clamping
Brief summary
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.
Interventions
PROCEDUREUmbilical Cord Milking
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.
PROCEDUREDelayed Cord Clamping
Performed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sharp HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 23 0/7 - 31 6/7 weeks gestation
Exclusion criteria
* Planned vaginal breech delivery * Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery) * Fetal death in utero * Red cell isoimmunization * Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization * Placenta accreta or abruption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Superior Vena Cava Flow | <12 hours of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Necrotizing enterocolitis | up to 24 weeks after birth | — |
| Neonatal death | up to 24 weeks of life | — |
| Use of uterotonic agents | up to 1 hour after birth | — |
| Peak transcutaneous and/or serum bilirubin concentrations | up to 24 weeks after birt | — |
| Maternal hemoglobin | within 48 hours after delivery | — |
| Intraventricular Hemorrhage detected on Head Ultrasound | up to 24 weeks after birth | — |
| Delivery Room Interventions | 10 minutes of life | — |
| Hemoglobin | <1 hour | — |
| Neurodevelopmental impairment 18-36 months | 18-36 months | — |
| Severe intraventricular hemorrhage (grade 3 or 4) | up to 24 weeks after birth | — |
| Phototherapy | up to 24 weeks after birth | Requirement and length of phototherapy |
| Ionotropic support | up to 24 weeks after birth | Requirement and length of ionotropic support |
| Neonatal intensive care unit (NICU) length of stay | up to 24 weeks after birth | — |
| Number of blood transfusions while in the neonatal intensive care unit | up to 24 weeks after birth | — |
| Ventilator time | up to 24 weeks after birth | — |
| Apgar score <7 at 5 minutes | at 5 minutes after birth | — |
| Umbilical cord pH < 7.0 | up to 30 minutes after birth | — |
| Blood pressure in first 2 hours of admission to neonatal intensive care unit | 2 hours after birth | — |
| Polycythemia | up to 24 hours of life | — |
Other
| Measure | Time frame |
|---|---|
| Cerebral Tissue Oxygenation | Up to 24 hours of life |
| Cardiac output by electric cardiometry | up to 24 hours of life |
| Stroke volume by electric cardiometry | Up to 24 hours of life |
| Vaginal Delivered infants (no difference in interventions) | up to 24 weeks after birth |
| Days on Oxygen | during hospitalization |
Countries
United States
Outcome results
None listed