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Parenteral Retinol Level and Tolerability Trial
EU CTIS ID: 2024-516994-59-00
What this study is testing
Objectives - Primary: To assess Retinol serum concentration at Days 0 and 28, in preterm infants, with GA between 22 weeks + 0 day and 29 weeks + 6 days. To evaluate the safety and tolerability of RetinolX from Day 0 to week 36 Post-menstrual age (PMA).
- Therapeutic exploratory (Phase II)
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
- Very preterm infants with a GA <30 weeks (N=12): • 7 extremely preterm infants ≤27 weeks + 6 days GA and • 5 very preterm infants ≥28 weeks + 0 day GA and ≤29 weeks + 6 days GA to cover data from both sub-populations of preterm infants <30 weeks
- Enrollment between 24 hours (h) and 72 h of birth. Note: All genders and ethnicities are eligible for the study.
- Informed consent must be obtained from the parents of the infants prior to enrollment in the study.
You likely can't join if
- Major congenital anomalies
- Intraventricular Hemorrhage (IVH) grade 2-4
- Infants at a high mortality risk, as judged by the hospital principal investigator (PI), for example • Terminal illness as evidenced by severe acidosis (pH < 7.0 for > 2 h) or persistent bradycardia (heart rate < 100 beats per minute) associated with hypoxia for > 2 h • Congenital nonbacterial infection with overt signs at birth
- Infants who are to receive vitamin A in a parenteral fat emulsion in doses exceeding recommendations for multivitamin preparations.
- Infants born preterm due to maternal exposure to modifiable risk factors such as smoking, alcohol consumption, substance abuse, or other known teratogenic exposures.
The study team makes the final eligibility decision.
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.
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.