VentFirst for Extremely Preterm Infants

Not currently recruiting at 13 trial locations

Overseen By Gina Duda

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Severe hydrops, Lethal chromosomal abnormality, Severe congenital malformation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-birth intervention

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether providing breathing support to extremely preterm infants (born between 23 and 28 weeks) before cutting the umbilical cord reduces brain bleeding compared to the usual method of waiting to provide breathing support. The trial includes two groups: one receives standard care, involving delayed cord cutting followed by breathing support, while the other receives VentFirst, which provides breathing support before cutting the cord. Infants born between 23 and 28 weeks without certain severe health issues may be suitable for this trial. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could improve outcomes for future preterm infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this protocol is safe for extremely preterm infants?

Research has shown that assisting extremely preterm babies with breathing before cutting the umbilical cord has been studied for safety. The findings indicate that this method does not reduce the risk of brain bleeding or early death compared to assisting with breathing after the cord is cut. However, it might help the baby adjust more smoothly to breathing and blood flow.

The studies found no major safety issues with providing this early breathing assistance, suggesting it is generally safe. While it may not reduce certain risks, current evidence supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VentFirst because it offers a new approach to treating extremely preterm infants by providing assisted ventilation before cutting the umbilical cord, instead of after. This method extends the time for cord clamping to 120 seconds, potentially improving oxygenation and stabilizing vital signs right from birth. Unlike the standard practice of delaying cord clamping for 30-60 seconds, VentFirst could enhance immediate respiratory support, which may lead to better outcomes for these vulnerable infants.

What evidence suggests that the VentFirst technique is effective for reducing intraventricular hemorrhage in extremely preterm infants?

This trial will compare two approaches for extremely preterm infants: the VentFirst method, which provides assisted ventilation before cord clamping at 120 seconds, and the standard practice of cord clamping at 30-60 seconds followed by assisted ventilation. Research has shown that assisting extremely premature babies with breathing before cutting the umbilical cord does not significantly reduce the risk of brain bleeding or early death. Several studies have found no clear advantage to this method compared to the usual practice of waiting to assist breathing until after the cord is cut. In these studies, the rates of brain bleeding and survival were similar for babies who received early breathing help and those who did not. Overall, strong evidence does not support that this early breathing support changes these important outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Karen Fairchild, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

Inclusion Criteria

23 0/7 - 28 6/7 weeks gestation at delivery

Exclusion Criteria

Suspected severe fetal anemia

You are carrying more than two fetuses (babies) at once.

The baby growing inside you has a very serious health problem that could be life-threatening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Newborns receive either standard care with delayed cord clamping and ventilatory assistance after, or the VentFirst intervention with ventilatory assistance before cord clamping.

Immediate post-birth intervention

In delivery room

Follow-up

Participants are monitored for safety and effectiveness, including the occurrence of intraventricular hemorrhage and other outcomes.

Up to 36 weeks' postmenstrual age

What Are the Treatments Tested in This Trial?

Interventions

• Standard Cord Clamping
• VentFirst

How Is the Trial Designed?

Group I: VentFirst 120 Seconds Cord Clamping Experimental Treatment 1 Intervention

Assisted ventilation (face mask continuous positive airway pressure, CPAP, or positive pressure ventilation, PPV) is provided prior to cord clamping at 120 seconds.

Group II: Standard 30-60 Seconds Cord Clamping Active Control 1 Intervention

Standard treatment for extremely preterm infants which is delayed cord clamping 30-60 seconds after birth, and assisted ventilation after cord clamping.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

St. Louis University

Collaborator

Trials

197

Recruited

41,400+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Mount Sinai Hospital, Canada

Collaborator

Trials

210

Recruited

70,700+

Published Research Related to This Trial

A standardized protocol for weaning preterm infants from nasal high flow therapy (nHFT) significantly reduced the failure rate of weaning, with only 7.8% of infants failing compared to 28.3% in the nonprotocolized group.

The protocol group also achieved full enteral feeding faster than the nonprotocol group, indicating that a structured approach to weaning can improve feeding outcomes without increasing risks of respiratory support or neonatal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a protocol-based strategy for weaning nasal high flow therapy in preterm infants. Abobakr, M., Abdalla, A., Barakat, T., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38758557/

Ventilatory Assistance Before Umbilical Cord Clamping in ... This study did not show that providing assisted ventilation before cord clamping in extremely preterm infants reduces IVH or early death.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818953

Ventilatory Assistance Before Umbilical Cord Clamping in ... In this study, assisting ventilation prior to cord clamping did not reduce IVH or death compared with cord clamping followed by standard resuscitation.

3. nature.com nature.com/articles/s41372-025-02258-5

Does ventilatory assistance before umbilical cord clamping ... The VentFirst study did not show any benefit in IVH/death or hematocrit at 24 h with respiratory support during DCC in the breathing well group ...

4. withpower.com withpower.com/trial/phase-hemorrhage-5-2016-ea66c

VentFirst for Extremely Preterm Infants · Info for Participants This trial tests if giving extremely preterm babies breathing support right after birth can reduce brain bleeding. The goal is to see if this early support ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11102017/

Ventilatory Assistance Before Umbilical Cord Clamping in ... For extremely preterm infants, does providing ventilatory assistance during 120 seconds of delayed umbilical cord clamping, compared with 30 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0146000523000915

Assisted ventilation prior to umbilical cord clamping Providing assisted ventilation prior to cord clamping (V-DCC) leads to a more stable transition of cerebral, pulmonary and systemic circulation and oxygenation.