N/A
N=34
Cardiac and Cerebral Hemodynamics With Umbilical Cord Milking Compared With Early Cord Clamping
Birth Asphyxia With Neurologic Involvement
Bottom Line
View on ClinicalTrials.gov: NCT03621956 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: StO2 in the First 10 Minutes of Life — 70; 74.5 percent
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 StO2 in the First 10 Minutes of Life |
70; 74.5 | — |
| SECONDARY Heart Rate at 10 Minutes |
152; 160 | — |
Summary
3 clinical sites enrolling in the primary MINVI trial (NCT03631940) will collect Near Infrared Spectroscopy (NIRS) data in the first 10 minutes of life on a subset of 200 non-vigorous term and near-term infants enrolled in the trial.
Eligibility Criteria
Inclusion Criteria
- Non-vigorous newborns born between 35-42 weeks gestation
- Born at NIRS Sub-study site
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 Avulsion
- 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 (NCT03621956). 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.