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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Mayo Clinic | OTHER |
| St. Louis University | OTHER |
| University of Colorado, Denver |
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The purpose of this study is to determine whether providing ventilatory assistance prior to umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in extremely preterm (EPT) infants, compared to standard care of providing ventilatory assistance after cord clamping.
Newborns with gestational age 23 wks 0 days through 28 wks 6 days are randomized to control (delayed cord clamping for at least 30 seconds, or up to 60 seconds if breathing spontaneously, with ventilatory assistance provided after) or the VentFirst intervention (ventilatory assistance with continuous positive airway pressure or positive pressure ventilation given starting 30 seconds after birth and cord clamping at 120 seconds).
The primary outcome is lack of IVH on 7-10 day head ultrasound or death before day 7.
The study was designed to test the impact of the intervention in each of two cohorts:
Randomization and analysis is stratified by gestational age category:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard 30-60 Seconds Cord Clamping | Active Comparator | Standard treatment for extremely preterm infants which is delayed cord clamping 30-60 seconds after birth, and assisted ventilation after cord clamping. |
|
| VentFirst 120 Seconds Cord Clamping | Experimental | Assisted ventilation (face mask continuous positive airway pressure, CPAP, or positive pressure ventilation, PPV) is provided prior to cord clamping at 120 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard 30-60 Seconds Cord Clamping | Procedure | The infant is stimulated to breathe after birth. If the infant is not breathing well, the cord is clamped at 30 seconds. If the baby is breathing well, the cord is clamped at 60 seconds. Ventilatory assistance is given after cord clamping. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age | presence of any grade IVH on HUS | 7-10 days after birth |
| Measure | Description | Time Frame |
|---|---|---|
| 5 minute Apgar Score <5 | Low Apgar score (<5) at 5 minutes | 5 minutes after birth |
| Lowest hematocrit in first 24 hours | Median, 25th & 75th percentiles |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal post-partum hemorrhage | >= 1000 mL estimated blood loss | First 24 hours after delivery |
| Maternal red blood cell transfusion | Administration of an RBC transfusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Fairchild, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of California, Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42332050 | Derived | Strand ML, Bulas DI, Niermeyer S, Fang JL, Warren JB, Josephsen JB, Epelman M, Kline-Fath BM, Petroni GR, Fairchild KD. Rates and predictors of intraventricular hemorrhage in the ventfirst trial with comparison to a contemporaneous cohort. J Perinatol. 2026 Jun 22. doi: 10.1038/s41372-026-02751-5. Online ahead of print. | |
| 41284295 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 6, 2025 | |
| Reset | Nov 18, 2025 |
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| OTHER |
| Oregon Health and Science University | OTHER |
| University of Calgary | OTHER |
| Columbia University | OTHER |
| Indiana University | OTHER |
| University of California, Davis | OTHER |
| University of Alberta | OTHER |
| University of Alabama at Birmingham | OTHER |
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Board-certified radiologists interpreting head ultrasound findings are blinded to study arm. Consensus on maximum grade of IVH between two radiologists (some combination of site radiologist and one of three external readers blinded to each others' interpretation) is required.
|
| VentFirst 120 Seconds Cord Clamping | Procedure | The infant is stimulated to breathe after birth. If the infant is not breathing well, PPV by face mask is given starting at 30 seconds. If the baby is breathing well, CPAP is given starting at 30 seconds. The cord is clamped at 120 seconds. |
|
| First 24 hours after birth |
| Medication for low blood pressure in first 24 hours | Hydrocortisone and/or vasopressor for hypotension | First 24 hours after birth |
| Number of red blood cell transfusions birth through day 10 | Median, 25th & 75th percentiles | First 10 days after birth |
| Severe brain injury on head ultrasound | Grade 3-4 IVH and/or cerebellar hemorrhage and/or cystic periventricular leukomalacia on head ultrasound at 7-10 days of age and/or near 36 weeks' postmenstrual age | Birth through 36 weeks' postmenstrual age |
| Death | All-cause mortality | Birth through 36 weeks' postmenstrual age |
| Prior to maternal hospital discharge |
| Maternal retained placenta | Retained placenta | Prior to hospital discharge |
| Maternal post-partum delivery related infection | Diagnosis of a delivery related infection | Prior to maternal hospital discharge |
| Apgar scores | Apgar scores taken in the delivery room (1, 5, 10 minutes) | 1 minute, 5 minutes, and 10 minutes after delivery |
| Umbilical Cord Blood Gas | Umbilical cord venous and arterial pH | In delivery room |
| Chest compressions or epinephrine | occurrence of infant chest compressions or administration of epinephrine | In delivery room |
| Volume Bolus | administration of a volume bolus | In delivery room |
| Intubation | Endotracheal intubation | In delivery room |
| Admission hypothermia <36.5°C | <36.5°C | at admission to the Neonatal Intensive Care Unit |
| Pneumothorax | Diagnosis of pneumothorax requiring intervention | first 24 hours after delivery |
| NICU admission temperature | Infant's NICU admission temperature | At NICU admission |
| SNAPPE-II Score | Score for Neonatal Acute Physiology-Perinatal Extension | First 12 hours after birth |
| Red blood cell transfusion | Administration of an RBC transfusion | First 24 hours after birth |
| Highest hematocrit | Infant's highest hematocrit (before transfusion) | First 24 hours after birth |
| Lowest mean arterial blood pressure | Infant's lowest mean arterial blood pressure (cuff or arterial catheter) | First 24 hours after birth |
| Volume Bolus | Any volume bolus including the delivery room, and including NICU packed red blood cells, platelets, plasma, saline, or other fluid bolus | First 24 hours after birth |
| Surfactant administration | Administration of surfactant | First 10 days after birth |
| Mechanical ventilation days | Number of days on mechanical ventilation via an endotracheal tube | First 10 days after birth |
| Early-Onset Septicemia | Positive blood culture in first 3 days and treated with at least 5 days of antibiotics | <72 hours after birth |
| Highest bilirubin | Highest bilirubin recorded | First 10 days after birth |
| Phototherapy duration | Number of days on phototherapy | First 10 days after birth |
| Intraventricular hemorrhage | Highest grade of IVH | Prior to 36 weeks' postmenstrual age |
| Cerebellar hemorrhage | occurrence of cerebellar hemorrhage | Prior to 36 weeks' postmenstrual age |
| Late-Onset Septicemia | Positive blood culture after first 3 days and treated with at least 5 days of antibiotics | Prior to 36 weeks' postmenstrual age |
| Cystic Periventricular Leukomalacia (cPVL) | Occurrence of cPVL | Prior to 36 weeks' postmenstrual age |
| Patent Ductus Arteriosus (PDA) | occurrence of PDA requiring pharmacological or surgical treatment | Prior to 36 weeks' postmenstrual age |
| Spontaneous intestinal perforation (SIP) | SIP without NEC and requiring surgery or peritoneal drain | Prior to 36 weeks' postmenstrual age |
| Necrotizing Enterocolitis (NEC) | Occurrence of NEC modified Bell's stage 2-3 | Prior to 36 weeks' postmenstrual age |
| Bronchopulmonary Dysplasia (BPD) | Occurrence of BPD receiving continuous supplemental oxygen | At 36 weeks' postmenstrual age |
| Severe ROP | occurrence of ROP stage 3 or treated with laser or bevacizumab | Prior to 36 weeks' postmenstrual age |
| Sacramento |
| California |
| 95817 |
| United States |
| University of Colorado | Denver | Colorado | 80045-2571 | United States |
| University of Indiana | Indianapolis | Indiana | 46202 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115-6110 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905-0001 | United States |
| St. Louis University | St Louis | Missouri | 63103-2006 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Oregon Health & Science University | Portland | Oregon | 37239-0000 | United States |
| University of Virginia | Charlottesville | Virginia | 22904-4195 | United States |
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada |
| University of Alberta, Edmonton | Edmonton | Alberta | T5H 3V9 | Canada |
| Fang JL, Fairchild KD, Petroni GR, Strand ML, Warren JB, Law BH, Gorman TE, Leone TA, Thomas SP, Niermeyer S; VentFirst Consortium. Physiologic Transition During Delayed Cord Clamping With Assisted Ventilation in Preterm Infants: A Secondary Analysis of the VentFirst Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2545258. doi: 10.1001/jamanetworkopen.2025.45258. |
| 38758557 | Derived | Fairchild KD, Petroni GR, Varhegyi NE, Strand ML, Josephsen JB, Niermeyer S, Barry JS, Warren JB, Rincon M, Fang JL, Thomas SP, Travers CP, Kane AF, Carlo WA, Byrne BJ, Underwood MA, Poulain FR, Law BH, Gorman TE, Leone TA, Bulas DI, Epelman M, Kline-Fath BM, Chisholm CA, Kattwinkel J; VentFirst Consortium. Ventilatory Assistance Before Umbilical Cord Clamping in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2411140. doi: 10.1001/jamanetworkopen.2024.11140. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 6, 2025 | Nov 18, 2025 |