VentFirst for Extremely Preterm Infants

Recruiting at 12 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

570 Participants Needed

Trial Summary

What is the purpose of this trial?

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 helps stabilize their condition better than the usual method.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment VentFirst for Extremely Preterm Infants?

The research suggests that nasal high-frequency oscillatory ventilation (nHFOV), a component of the VentFirst treatment, may help with better carbon dioxide elimination and feeding tolerance in preterm infants, although more studies are needed to confirm these benefits. ^{1 2 3 4 5}

How is the VentFirst treatment different from other treatments for extremely preterm infants?

The VentFirst treatment is unique because it focuses on a specific ventilation strategy for extremely preterm infants, which may involve novel approaches or technologies not covered by conventional, high-frequency oscillatory, or high-frequency jet ventilation. This could include differences in how the ventilation is administered or managed, aiming to improve respiratory outcomes in these vulnerable infants. ^{1 6 7 8 9}

Research Team

Karen Fairchild, MD

Principal Investigator

University of Virginia

Eligibility Criteria

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

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

Treatment Details

Interventions

• Standard Cord Clamping
• VentFirst

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Hazards to avoid in future neonatal studies of nasal high-frequency oscillatory ventilation: lessons from an early terminated trial. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes at 18 to 22 Months of Corrected Age for Infants Born at 22 to 25 Weeks of Gestation in a Center Practicing Active Management. [2020]

3. China pubmed.ncbi.nlm.nih.gov

[Safety of two ventilator weaning strategies after high-frequency oscillatory ventilation in preterm infants with respiratory distress syndrome: a prospective randomized controlled trial]. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Nasal HFOV versus nasal IPPV as a post-extubation respiratory support in preterm infants-a randomised controlled trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Implementation of a protocol-based strategy for weaning nasal high flow therapy in preterm infants. [2021]

6. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Success rate and neonatal morbidities associated with early extubation in extremely low birth weight infants. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Ventilation in Extremely Preterm Infants and Respiratory Function at 8 Years. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Long term follow-up of very low birthweight infants from a neonatal volume versus pressure mechanical ventilation trial. [2010]

9. United States pubmed.ncbi.nlm.nih.gov

Ventilator Management in Extremely Preterm Infants. [2022]