Intraventricular HemorrhageNCT02742454
VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
A study testing Standard 30-60 Seconds Cord Clamping and VentFirst 120 Seconds Cord Clamping in people with Intraventricular Hemorrhage, run by University of Virginia at 12 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intraventricular Hemorrhage
- What is being tested?
- Standard 30-60 Seconds Cord Clamping and VentFirst 120 Seconds Cord Clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jun 2016to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 23 0/7 - 28 6/7 weeks' gestation at delivery
Who cannot join
- Life-threatening condition of fetus (e.g. severe hydrops, lethal chromosomal abnormality, severe congenital malformation)
- Suspected severe fetal anemia
- Monochorionic or monoamniotic twins
- Multiple gestation greater than twins
- Decision made for comfort care only
- Medical emergency necessitating emergency delivery (e.g. complete placental abruption)
- Obstetrician or Neonatology concern for inappropriateness of the study intervention based on maternal or fetal factors.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States10 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Brigham & Women's Hospital
Boston, Massachusetts, 02115-6110
University of Virginia
Charlottesville, Virginia, 22904-4195
University of Colorado
Denver, Colorado, 80045-2571
University of Indiana
Indianapolis, Indiana, 46202
Columbia University Medical Center
New York, New York, 10032
Oregon Health & Science University
Portland, Oregon, 37239-0000
Mayo Clinic
Rochester, Minnesota, 55905-0001
University of California, Davis
Sacramento, California, 95817
St. Louis University
St Louis, Missouri, 63103-2006
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 1N4
University of Alberta, Edmonton
Edmonton, Alberta, T5H 3V9
About this study
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.
Read the detailed description
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:
- Infants not breathing well 30 seconds after birth
- Infants breathing well 30 seconds after birth
Randomization and analysis is stratified by gestational age category:
- 23 0/6 to 25 6/7 weeks' gestation
- 26 0/7 to 28 6/7 weeks' gestation
- Conditions
- Intraventricular Hemorrhage
- Being tested
- Standard 30-60 Seconds Cord Clamping, VentFirst 120 Seconds Cord Clamping
- Keywords
- Umbilical Cord Clamping, Intraventricular Hemorrhage, Extremely Preterm Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard 30-60 Seconds Cord ClampingProcedure or surgery
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.
VentFirst 120 Seconds Cord ClampingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Standard 30-60 Seconds 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. Receives: Procedure: VentFirst 120 Seconds Cord Clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age
presence of any grade IVH on HUS
Measured: 7-10 days after birth
Secondary outcomes (6)
5 minute Apgar Score <5
Low Apgar score (<5) at 5 minutes
Measured: 5 minutes after birth
Lowest hematocrit in first 24 hours
Median, 25th \& 75th percentiles
Measured: First 24 hours after birth
Medication for low blood pressure in first 24 hours
Hydrocortisone and/or vasopressor for hypotension
Measured: First 24 hours after birth
Number of red blood cell transfusions birth through day 10
Median, 25th \& 75th percentiles
Measured: 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
Measured: Birth through 36 weeks' postmenstrual age
Death
All-cause mortality
Measured: Birth through 36 weeks' postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2023
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraventricular HemorrhageStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Mayo Clinic, St. Louis University, University of Colorado, Denver, Oregon Health and Science University, University of Calgary, Columbia University, Indiana University, University of California, Davis, University of Alberta, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Karen Fairchild, MD, University of Virginia
- Investigators
- Karen Fairchild, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742454
- Sponsor's protocol ID
- 18783
- Status last verified
- Oct 2023
- First submitted
- 14 Apr 2016
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 42332050Fang 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.
PubMed 41284295Fairchild 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.
PubMed 38758557
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
- ClinicalTrials.gov ID
- NCT02742454
- Acronym / sponsor ID
- 18783
- Conditions
- Intraventricular Hemorrhage
- Keywords
- Umbilical Cord Clamping, Intraventricular Hemorrhage, Extremely Preterm Infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 570 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Mayo Clinic, St. Louis University, University of Colorado, Denver, Oregon Health and Science University, University of Calgary, Columbia University, Indiana University, University of California, Davis, University of Alberta, University of Alabama at Birmingham
- Study start
- Jun 2016
- Primary completion
- Mar 2023 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Infants not breathing well 30 seconds after birth
- Infants breathing well 30 seconds after birth
Randomization and analysis is stratified by gestational age category:
- 23 0/6 to 25 6/7 weeks' gestation
- 26 0/7 to 28 6/7 weeks' gestation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard 30-60 Seconds Cord Clamping | Active comparator | Procedure: Standard 30-60 Seconds Cord ClampingStandard 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 | Procedure: VentFirst 120 Seconds Cord ClampingAssisted ventilation (face mask continuous positive airway pressure, CPAP, or positive pressure ventilation, PPV) is provided prior to cord clamping at 120 seconds. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 23 0/7 - 28 6/7 weeks' gestation at delivery
Key exclusion criteria (7 listed)
- Life-threatening condition of fetus (e.g. severe hydrops, lethal chromosomal abnormality, severe congenital malformation)
- Suspected severe fetal anemia
- Monochorionic or monoamniotic twins
- Multiple gestation greater than twins
- Decision made for comfort care only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard 30-60 Seconds Cord ClampingThe 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. | Procedure or surgery | Standard 30-60 Seconds Cord Clamping |
| VentFirst 120 Seconds Cord ClampingThe 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. | Procedure or surgery | VentFirst 120 Seconds Cord Clamping |
Primary outcome
Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age
Time frame: 7-10 days after birth
presence of any grade IVH on HUS
6 secondary outcomes
5 minute Apgar Score <5
Time frame: 5 minutes after birth
Lowest hematocrit in first 24 hours
Time frame: First 24 hours after birth
Medication for low blood pressure in first 24 hours
Time frame: First 24 hours after birth
Number of red blood cell transfusions birth through day 10
Time frame: First 10 days after birth
Severe brain injury on head ultrasound
Time frame: Birth through 36 weeks' postmenstrual age
Death
Time frame: Birth through 36 weeks' postmenstrual age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 42332050Strand 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.
- Derived from this study: PubMed 41284295Fang 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.
- Derived from this study: PubMed 38758557Fairchild 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Fairchild, MD principal investigator
University of Virginia
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard 30-60 Seconds Cord Clamping and VentFirst 120 Seconds Cord Clamping in people with Intraventricular Hemorrhage, run by University of Virginia at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraventricular Hemorrhage on Head Ultrasound or death before 7 days of age (time frame: 7-10 days after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742454, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.