Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
Conditions
Brief summary
The purpose of the study is to determine if neonates (who already have an increased risk of hyperbilirubinemia due to mother's history of having previous neonate who received phototherapy for hyperbilirubinemia) have higher bilirubin levels 24 hours after birth with delayed cord clamping.
Interventions
PROCEDUREDelayed cord clamping
The umbilical cord will be clamped after 60 seconds after birth
PROCEDUREEarly cord clamping
The umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* mothers delivering at 35 weeks or greater * mothers who have had at least 1 previous child that received phototherapy for hyperbilirubinemia * multiple gestations can be included unless the neonate does not meet criteria for delayed cord clamping as described below or due to concerns about safety of delayed cord clamping for timing of delivery of the 2nd twin (ie: 2nd twin requires immediate delivery intervention)
Exclusion criteria
\- Neonates who do not meet criteria for delayed cord clamping (any infant that any provider in the room felt needed evaluation by the neonatal transport team immediately so that the infant would be handed off for resuscitation. If the patient required delivery by cesarean section the delayed cord clamping protocol would be abandoned).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal bilirubin level | 24 hours after birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of neonates with hyperbilirubinemia | 24 hours after birth | Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood. |
| Number of neonates with a need for phototherapy | From birth to up to 1 week after birth | — |
| Number of neonates with a need for exchange transfusion | From birth to up to 1 week after birth | — |
| Number of neonates admitted to the neonatal intensive care unit (NICU) | From birth to up to 1 week after birth | — |
| Number of mothers with postpartum hemorrhage | From birth to up to 1 week after birth | — |
| Number of neonates re-hospitalized for jaundice | From birth to up to 1 week after birth | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPamela D Berens, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed