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

Investigating Delayed Cord Clamping and Breathing Assistance in Premature Infants

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

We are testing whether assisting breathing prior to cord clamping at 120 seconds is beneficial compared to the current standard of care. At IU the current standard for EPT babies is clamping the cord at 30 seconds after birth if the baby is not breathing well, or 60 seconds after birth if the baby is breathing well. Breathing assistance is given after the cord is clamped.

The purpose of this study is to determine whether delaying the clamping of the cord up to 120 seconds and assisting breathing for EPT babies during that time before clamping the umbilical cord can reduce IVH and perhaps some other complications of prematurity.

Detailed description of study

We are testing whether assisting breathing prior to cord clamping at 120 seconds is beneficial compared to the current standard of care. At IU the current standard for EPT babies is clamping the cord at 30 seconds after birth if the baby is not breathing well, or 60 seconds after birth if the baby is breathing well. Breathing assistance is given after the cord is clamped.

The purpose of this study is to determine whether delaying the clamping of the cord up to 120 seconds and assisting breathing for EPT babies during that time before clamping the umbilical cord can reduce IVH and perhaps some other complications of prematurity.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: preterm infant,premature birth
  • Age: 100 years or below
  • Gender: All

This study investigates whether delaying the clamping of the umbilical cord up to 120 seconds and providing breathing assistance to extremely preterm (EPT) babies during that time can reduce the risk of intraventricular hemorrhage (IVH) and other complications related to prematurity. EPT refers to babies born significantly earlier than the full-term pregnancy period, and IVH is a type of bleeding in the brain that can occur in these infants.

The study procedures involve comparing two approaches: the current standard practice of clamping the cord at 30 to 60 seconds after birth, depending on the baby's breathing status, and the investigational method of delaying clamping to 120 seconds while providing breathing support before the cord is clamped. This aims to assess if early breathing assistance can improve health outcomes for EPT infants.

  • Who can participate: Infants eligible for this study are those born significantly earlier than the full-term pregnancy period, specifically those classified as extremely preterm. Additional eligibility criteria include the absence of congenital anomalies and the requirement for immediate postnatal care.
  • Study details: Participants in this study will either follow the current standard procedure or receive breathing assistance before the umbilical cord is clamped at 120 seconds. A placebo is not used in this study. Participants will undergo monitoring of vital signs and health outcomes to assess the effectiveness of the delayed clamping and breathing assistance.
Updated on 19 Feb 2024. Study ID: 1802341765

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