N/A
N=860
Umbilical Cord Milking in Non-Vigorous Infants
Birth Asphyxia
Bottom Line
View on ClinicalTrials.gov: NCT03631940 ↗Enrolled (actual)
860
Serious AEs
0.2%
Results posted
Sep 2024
Primary outcome: Primary: Number of Neonatal Participants Admitted to the NICU for Predefined Criteria — 199; 239; 53; 52 Participants — p=.87
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Umbilical Cord Milking (Procedure); Early Cord Clamping (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sharp HealthCare
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Neonatal Participants Admitted to the NICU for Predefined Criteria |
199; 239; 53; 52; 620; 567 | .87 |
| SECONDARY Median Neonatal Hemoglobin Between 12 to 48 Hours of Life |
18.0; 17.3 | — |
| SECONDARY Number of Neonates Treated With Therapeutic Hypothermia ("Cooling") |
21; 35 | — |
| SECONDARY Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life |
58; 56 | — |
| SECONDARY Median Peak Total Serum Bilirubin in Neonates |
8.4; 7 | — |
| SECONDARY Median Transcutaneous Bilirubin in Neonates |
7.1; 6.5 | — |
| SECONDARY Number of Neonatal Deaths |
0; 4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03631940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.