VentFirst: A Study of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants

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Age: -1 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: premature, preemie, delayed cord clamping, cord clamping, umbilical cord, assisted ventilation
Type: Procedure study, Phase 3
Target:
250 Participants
Investigator:
Description
This study is called VentFirst. In VentFirst, we are testing whether assisting breathing prior to cord clamping at 120 seconds is beneficial. We will compare this to the current standard of care.

At UC Davis the current standard for EPT babies is clamping the cord at 30 seconds after birth if the baby is not breathing well. It is clamped at 60 seconds after birth if the baby is breathing well. Breathing assistance is given after the cord is clamped.

The purpose of this research is to study delayed clamping of the cord up to 120 seconds along with assisted breathing for EPT babies. We hope to learn if this procedure can reduce IVH and other complications of prematurity.

You are being asked to be in this study because your baby is less than 29 weeks old and you are at risk for delivering an extremely premature baby.
This study requires

Screening (Before Delivery) If you are agree to take part in this study, you will sign this consent form before any study related procedures take place. A member of the study team will review your medical record to confirm that you meet the requirements to be in the study. There are no special blood tests or other studies that have to be done to make sure you are eligible to take part in the VentFirst study. Once you sign the consent, you and your baby are considered enrolled in the study.

Randomization and Study Intervention- In the Delivery room: Once you come into the delivery room, we are asking permission to audiotape the delivery. This will help us make sure that we do not miss any information during the study intervention. Some personal health information such as name and date of birth may be recorded on the audio tape. The tape will be only be reviewed by members of the study team. It will not be available to you or to anyone outside the VentFirst study team.

Shortly before you deliver you will be randomly assigned (like the flip of a coin) to one of two study groups. You have an equal chance of being assigned to either one of the groups, and you cannot choose to which group you are assigned.

Standard Group: Cord will be clamped 30 seconds after birth if your baby is not breathing well, or 60 seconds after birth if your baby is breathing well. Breathing assistance standard for all extremely premature infants will be given after the cord is clamped.

VentFirst Group: Cord will be clamped 120 seconds (2 minutes) after birth. Breathing assistance will be given from 30-120 seconds after birth while your baby remains attached by the umbilical cord to the placenta.

If your baby is randomized to the Standard Group, the following will happen: The neonatology team will determine whether or not your baby is breathing well by 30 seconds after birth • If your baby is not breathing well, the cord will be clamped and cut at 30 seconds and the baby will be moved to the resuscitation area for breathing assistance. • If your baby is breathing well at 30 seconds, the cord will be clamped and cut at 60 seconds (or sooner if your baby stops breathing well) and the baby will be moved to the resuscitation area.

If your baby is randomized to the VentFirst Group, the following will happen: • Your baby will receive breathing assistance while attached by the umbilical cord to the placenta from 30-120 seconds after birth. • The cord will be clamped and cut at 120 seconds from birth and the baby will be moved to the resuscitation area.

For BOTH GROUPS: The breathing assistance provided might be one of the three standard methods which are recommended for extremely preterm infants. 1. CPAP (Continuous Positive Airway Pressure given by face mask) if your baby is breathing well, or 2. PPV (Positive Pressure Ventilation or breaths given by face mask) if your baby is not breathing well 3. If your baby needs to be intubated (have a breathing tube placed into the airway to give breaths), this will be done after cord clamping, at the neonatal resuscitation area.

In summary the only differences in the two study groups are 1. How long after delivery the cord is clamped (30-60 seconds versus two minutes) 2. When breathing assistance is started relative to cord clamping (after versus before) 3. Where initial breathing assistance is given, as described above (in the neonatology resuscitation area versus next to you while still attached by the umbilical cord to the placenta)

Note: If the obstetrician or neonatologist thinks there is an emergency need to clamp the cord before the assigned time, this will be done right away regardless of which group your baby is randomized to.

Who can participate

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.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The study takes place in the delivery room in the first two minutes after your baby is born. Data will be collected from your medical record until you are discharged from the hospital after delivery. Data will be collected from your baby’s medical record until 36 weeks corrected age (gestational age at birth plus weeks of age after birth).
Recruitment period
From Sept. 5, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Intraventricular Hemorrhage

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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