Trial · NCT03631940
Umbilical Cord Milking in Non-Vigorous Infants
NCT03631940, Not applicable, Completed, Sharp HealthCare; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Umbilical Cord Milking in Non-Vigorous Infants. Trials, record NCT03631940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03631940
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Umbilical Cord Milking in Non-Vigorous Infants
- NCT number
- NCT03631940
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,730 participants, actual
- Lead sponsor
- Sharp HealthCare
- Conditions
- Birth Asphyxia
- Interventions
- Umbilical Cord Milking, Early Cord Clamping
- First posted
- 2018-08-15
- Last updated
- 2024-09-19
- Results first posted
- 2024-09-19
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Neonatal Participants Admitted to the NICU for Predefined Criteria | 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 | Median Neonatal Hemoglobin Between 12 to 48 Hours of Life | 12-48 hours of life | Single hemoglobin measurement for the neonate which was obtained between 12 to 48 hours of life collected with written consent or as part of standard care. |
| Secondary | Number of Neonates Treated With Therapeutic Hypothermia ("Cooling") | Birth to 78 hours of life. | Number of neonates that were treated with therapeutic hypothermia (Cooling to 33.5 degrees Celsius) for 72 hours and initiated within the first 6 hours of life. |
| Secondary | Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life | Birth through 24 hours of life | Number of neonates treated with normal saline bolus in the first 24 hours of life to support blood pressure. |
| Secondary | Median Peak Total Serum Bilirubin in Neonates | First week of life | Highest single measurement of total serum bilirubin obtained as part of standard care to assess hyperbilirubinemia in neonate. |
| Secondary | Median Transcutaneous Bilirubin in Neonates | birth to 7 days of life | Highest single measurement of transcutaneous bilirubin obtained as part of standard care to assess hyperbilirubinemia in each neonate. |
| Secondary | Number of Neonatal Deaths | Birth to discharge, assessed up to 180 days of life. | Number of neonatal deaths prior to discharge |
| Other | Number of Neonates Diagnosed With Mild, Moderate or Severe Hypoxic Ischemic Encephalopathy | Birth to discharge, up to 120 days of life. | Number of neonates with a diagnosis of mild, moderate or severe hypoxic ischemic encephalopathy during neonatal intensive care unit admission. |
| Other | Median Length of Neonate's Hospitalization in Days Among Participants Discharged Alive | birth to discharge, up to 120 days of life. | Number of days neonate was admitted to the neonatal intensive care unit from birth to discharge home. |
| Other | Median Neonatal Admission Blood Pressure | Birth to 48 hours of life. | First single neonatal blood pressure measurement by cuff or arterial line obtained on admission to the neonatal intensive care unit and by 48 hours of life. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Neonatal Participants Admitted to the NICU for Predefined Criteria | Birth to first 48 hours of life. | Neonates with admission disposition status | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Neonatal Hemoglobin Between 12 to 48 Hours of Life | 12-48 hours of life | Neonates with a hemoglobin measurement obtained between 12 to 48 hours of life either by standard or care of with parental consent. | g/dL | MEDIAN |
| SECONDARY | Number of Neonates Treated With Therapeutic Hypothermia (Cooling) | Birth to 78 hours of life. | Neonates with admission disposition status | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life | Birth through 24 hours of life | Neonates with admission disposition status | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Peak Total Serum Bilirubin in Neonates | First week of life | All neonates with a total serum bilirubin result from a blood test obtained as part of standard care. | mg/dL | MEDIAN |
| SECONDARY | Median Transcutaneous Bilirubin in Neonates | birth to 7 days of life | All neonates with a transcutaneous bilirubin measurement in the first week of life as part of standard care. | mg/dL | MEDIAN |
| SECONDARY | Number of Neonatal Deaths | Birth to discharge, assessed up to 180 days of life. | Neonates with discharge status available | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Neonates Diagnosed With Mild, Moderate or Severe Hypoxic Ischemic Encephalopathy | Birth to discharge, up to 120 days of life. | Neonates with admission disposition status | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Median Length of Neonate's Hospitalization in Days Among Participants Discharged Alive | birth to discharge, up to 120 days of life. | Neonates with discharge status | days | MEDIAN |
| OTHER_PRE_SPECIFIED | Median Neonatal Admission Blood Pressure | Birth to 48 hours of life. | Neonates admitted to the neonatal intensive care unit with a blood pressure measurement in the first 48 hours of life. | mm Hg | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Neonatal Participants Admitted to the NICU for Predefined Criteria | Umbilical Cord Milking - Neonate | Total number of neonates admitted to the neonatal intensive care unit for predefined criteria | 199 | Participants | |
| Number of Neonatal Participants Admitted to the NICU for Predefined Criteria | Early Cord Clamping - Neonate | Total number of neonates admitted to the neonatal intensive care unit for predefined criteria | 239 | Participants | |
| Number of Neonatal Participants Admitted to the NICU for Predefined Criteria | Umbilical Cord Milking - Neonate | Total number of neonates admitted to neonatal intensive care unit for other criteria | 53 | Participants | |
| Number of Neonatal Participants Admitted to the NICU for Predefined Criteria | Early Cord Clamping - Neonate | Total number of neonates admitted to neonatal intensive care unit for other criteria | 52 | Participants | |
| Number of Neonatal Participants Admitted to the NICU for Predefined Criteria | Umbilical Cord Milking - Neonate | Total number of neonates without a neonatal intensive care unit admission | 620 | Participants | |
| Number of Neonatal Participants Admitted to the NICU for Predefined Criteria | Early Cord Clamping - Neonate | Total number of neonates without a neonatal intensive care unit admission | 567 | Participants | |
| Median Neonatal Hemoglobin Between 12 to 48 Hours of Life | Umbilical Cord Milking - Neonates | 18.0 | Inter-Quartile Range 16.3 to 19.4 | g/dL | |
| Median Neonatal Hemoglobin Between 12 to 48 Hours of Life | Early Cord Clamping - Neonates | 17.3 | Inter-Quartile Range 15.7 to 18.8 | g/dL | |
| Number of Neonates Treated With Therapeutic Hypothermia (Cooling) | Umbilical Cord Milking - Neonates | 21 | Participants | ||
| Number of Neonates Treated With Therapeutic Hypothermia (Cooling) | Early Cord Clamping - Neonates | 35 | Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Randomized Intervention Period 1 | STARTED | Umbilical Cord Milking, Then Early Cord Clamping - Neonate-Mother Dyad | 366 | 5 |
| Initial Randomized Intervention Period 1 | STARTED | Early Cord Clamping, Then Umbilical Cord Milking - Neonate-Mother Dyad | 494 | 5 |
| Initial Randomized Intervention Period 1 | COMPLETED | Umbilical Cord Milking, Then Early Cord Clamping - Neonate-Mother Dyad | 366 | 5 |
| Initial Randomized Intervention Period 1 | COMPLETED | Early Cord Clamping, Then Umbilical Cord Milking - Neonate-Mother Dyad | 494 | 5 |
| Initial Randomized Intervention Period 1 | NOT COMPLETED | Umbilical Cord Milking, Then Early Cord Clamping - Neonate-Mother Dyad | 0 | 0 |
| Initial Randomized Intervention Period 1 | NOT COMPLETED | Early Cord Clamping, Then Umbilical Cord Milking - Neonate-Mother Dyad | 0 | 0 |
| Crossover Intervention Period 2 | STARTED | Umbilical Cord Milking, Then Early Cord Clamping - Neonate-Mother Dyad | 364 | 5 |
| Crossover Intervention Period 2 | STARTED | Early Cord Clamping, Then Umbilical Cord Milking - Neonate-Mother Dyad | 506 | 5 |
| Crossover Intervention Period 2 | COMPLETED | Umbilical Cord Milking, Then Early Cord Clamping - Neonate-Mother Dyad | 364 | 5 |
| Crossover Intervention Period 2 | COMPLETED | Early Cord Clamping, Then Umbilical Cord Milking - Neonate-Mother Dyad | 506 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neonates with intraventricular hemorrhage grade 1 | Nervous system disorders | Umbilical Cord Milking-Neonates | 3 | 872 | 3 |
| other | Neonates with intraventricular hemorrhage grade 1 | Nervous system disorders | Early Cord Clamping-Neonates | 2 | 858 | 2 |
| other | Neonates with intraventricular hemorrhage grade 2 | Nervous system disorders | Umbilical Cord Milking-Neonates | 1 | 872 | 1 |
| other | Neonates with intraventricular hemorrhage grade 2 | Nervous system disorders | Early Cord Clamping-Neonates | 0 | 858 | 0 |
| serious | Neonates with intraventricular hemorrhage grade 3 or 4 as assessed by head ultrasound or MRI | Nervous system disorders | Umbilical Cord Milking-Neonates | 1 | 872 | 1 |
| serious | Neonates with intraventricular hemorrhage grade 3 or 4 as assessed by head ultrasound or MRI | Nervous system disorders | Early Cord Clamping-Neonates | 2 | 858 | 2 |
| serious | Neonates with polycythemia | Blood and lymphatic system disorders | Umbilical Cord Milking-Neonates | 0 | 872 | 0 |
| serious | Neonates with polycythemia | Blood and lymphatic system disorders | Early Cord Clamping-Neonates | 0 | 858 | 0 |
| serious | Neonates with pulmonary hemorrhage | Vascular disorders | Umbilical Cord Milking-Neonates | 0 | 872 | 0 |
| serious | Neonates with pulmonary hemorrhage | Vascular disorders | Early Cord Clamping-Neonates | 0 | 858 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Umbilical Cord Milking-Neonates | 0 | 872 |
| Total, all-cause mortality | Early Cord Clamping-Neonates | 4 | 858 |
| Total, other adverse events | Umbilical Cord Milking-Neonates | 4 | 872 |
| Total, other adverse events | Early Cord Clamping-Neonates | 2 | 858 |
| Total, serious adverse events | Umbilical Cord Milking-Neonates | 1 | 872 |
| Total, serious adverse events | Early Cord Clamping-Neonates | 2 | 858 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38949814 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD096023 | Umbilical Cord Milking in Non Vigorous Infants (the MINVI Trial) | KATHERIA, ANUP C | SHARP MEMORIAL HOSPITAL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2018 to 2022 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Umbilical Cord Milking - Neonates vs Early Cord Clamping - Neonates: Number of Neonates Treated With Therapeutic Hypothermia (Cooling) | Trial comparisons |
| Umbilical Cord Milking - Neonates vs Early Cord Clamping - Neonates: Number of Neonatal Deaths | Trial comparisons |
| Umbilical Cord Milking-Neonates vs Early Cord Clamping-Neonates: deaths from any cause | Trial comparisons |
| Umbilical Cord Milking - Neonates vs Early Cord Clamping - Neonates: Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life | Trial comparisons |
| Umbilical Cord Milking-Neonates vs Early Cord Clamping-Neonates: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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