A Study of the Effects of Initiating Assisted Ventilation During a Period of Delayed Cord Clamping for Extremely Preterm Infants

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-002670
    NCT ID: NCT02742454
    Sponsor Protocol Number: 18783

About this study

The purpose of this study is to determine whether initiating breathing assistance prior to clamping the umbilical cord influences the occurrence of intraventricular (brain) hemorrhage in extremely preterm infants, compared to the standard care of starting ventilation assistance after cord clamping.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Christopher Colby, M.D.

Open for enrollment

Contact information:

Lavonne Liedl R.R.T.

(507)255-1828

liedl.Lavonne@mayo.edu