Umbilical Cord Milking in Non-Vigorous Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Birth Asphyxia
- Sponsor
- Sharp HealthCare
- Enrollment
- 1730
- Locations
- 10
- Primary Endpoint
- Number of Neonatal Participants Admitted to the NICU for Predefined Criteria
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for infants who need resuscitation.
Detailed Description
At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. The currently recommended practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. This study will test whether infants will benefit from UCM. The cord will be quickly milked four times before cutting and will not delay the resuscitation procedures. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies from around the world have identified that infants needing resuscitation are more likely to develop conditions such as cerebral palsy, autism and other developmental problems. The trial is a cluster crossover design in which each hospital will be randomly assigned to use either early cord clamping or UCM for any infant needing resuscitation over a period of 12 months. Then sites will change to the other method for an additional 12 months.
Investigators
Anup Katheria, M.D.
Director, Neonatal Research Institute
Sharp HealthCare
Eligibility Criteria
Inclusion Criteria
- •Non-vigorous newborns born between 35-42 weeks gestation
Exclusion Criteria
- •Known major congenital or chromosomal anomalies of newborn
- •Known cardiac defects other than small ASD, VSD and PDA
- •Complete placental abruption/cutting through the placenta at time of delivery
- •Monochorionic multiples
- •Cord anomaly (i.e. cord avulsion, true knot)
- •Presence of non-reducible nuchal cord
- •Perinatal providers unaware of the protocol
- •Incomplete delivery data
- •Infants born in extremis, for whom additional treatment will not be offered
Outcomes
Primary Outcomes
Number of Neonatal Participants Admitted to the NICU for Predefined Criteria
Time Frame: Birth to first 48 hours of life.
Number of neonatal participants admitted to the neonatal intensive care unit for study-specific predefined criteria including respiratory distress, oxygen desaturation, hypoglycemia, hypotonia, apnea, lethargy or difficulty arousing, hypertonia or irritability, temperature instability, bradycardia or tachycardia, seizures or seizure-like activity, poor feeding or emesis, hyperbilirubinemia, death before NICU admission.
Secondary Outcomes
- Median Neonatal Hemoglobin Between 12 to 48 Hours of Life(12-48 hours of life)
- Number of Neonates Treated With Therapeutic Hypothermia ("Cooling")(Birth to 78 hours of life.)
- Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life(Birth through 24 hours of life)
- Median Peak Total Serum Bilirubin in Neonates(First week of life)
- Median Transcutaneous Bilirubin in Neonates(birth to 7 days of life)
- Number of Neonatal Deaths(Birth to discharge, assessed up to 180 days of life.)