Authorised Therapeutic confirmatory (Phase III) Prematurity

30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants

EU CTIS ID: 2023-509780-25-00

What this study is testing

The null hypothesis for this study is that the incidence of mortality or abnormal neurodevelopmental outcomes at 18-24 months corrected age will be no different by using either higher initial oxygen concentration of 60% compared to using lower initial oxygen concentration of 30% for resuscitation of preterm infants of 23-28 weeks’ gestation.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Infants with gestational age between 23 to 28 weeks based on best available obstetrical estimate
  • Infants designated to receive full resuscitation, i.e., no parental request or pre-determined decision to forego resuscitation
  • No known major congenital or chromosomal malformation.

You likely can't join if

  • Infant born outside of study centers and transported to center after delivery
  • Parents’ refusal to give consent to this study

The study team makes the final eligibility decision.

Where it's taking place

  • Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.