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Evaluation of Retinol Palmitate Administration and Serum Levels in Preterm Infants with Bronchopulmonary Dysplasia: A Phase 2a Open-Label Study

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What is this study about?

This clinical trial is focused on studying a condition known as Bronchopulmonary Dysplasia, which affects the lungs of very young infants, particularly those born prematurely. The study will use a treatment called RetinolX, which is a form of Vitamin A known as retinol palmitate. This treatment is given as a solution for injection and is specifically designed for preterm infants.

The purpose of the study is to understand how well preterm infants tolerate RetinolX and to measure the levels of retinol in their blood. The study will involve infants who are born very early, between 22 and 29 weeks of pregnancy. The treatment will be given from the time they are born until they reach 36 weeks of what is called post-menstrual age, which is the age they would be if they were still in the womb.

Throughout the study, the infants will receive injections of RetinolX, and their blood will be tested to see how much retinol is present at different times. The study will also look at how safe the treatment is by checking for any side effects or changes in the infants’ health. The goal is to see if the treatment can help improve the infants’ lung condition without causing any harm.

1 enrollment and study start

after signing the consent form, you receive a study identification number and basic information about the trial.

the study staff records your birth gestational age, which must be between 22 weeks 0 days and 29 weeks 6 days.

2 baseline assessment and first dose

on day 0 a blood sample is taken to measure your initial retinol level.

immediately after the sample, you receive the first retinolx injection.

the injection is a solution for injection containing 4750 iu/ml of retinol palmitate.

the medication is given by iv/im injection as directed by the study staff.

3 ongoing medication administration

you continue to receive retinolx by iv/im injection according to the schedule set by the study team.

the dose remains at 4750 iu/ml and is administered until you reach week 36 pma (post‑menstrual age).

the exact frequency (for example, once daily) is determined by the study protocol and communicated to you by the staff.

4 intermediate blood draws

on day 7 a second blood sample is taken to check the change in retinol level.

on day 14 another blood sample is collected for the same purpose.

on day 28 a third blood sample is drawn to evaluate the primary efficacy endpoint.

5 weekly safety monitoring

each week you have a brief visit during which the study staff checks for any adverse events, records vital signs, and reviews laboratory results.

any clinically significant changes are documented as part of the safety assessment.

6 final assessment

when you reach week 36 pma a final evaluation is performed.

the final visit includes a blood sample, a physical examination, and a review of all safety data collected during the study.

Who Can Join the Study?

  • The baby must be born very early, with a gestational age (the time the baby spent growing in the womb) of less than 30 weeks.
  • Two groups are included: infants born at 27 weeks and 6 days or earlier, called extremely preterm, and infants born between 28 weeks 0 days and 29 weeks 6 days, called very preterm.
  • The baby must be enrolled in the study when they are between 24 hours and 72 hours old after birth.
  • All genders (boys and girls) and all ethnic backgrounds are allowed to participate.
  • The parents or legal guardians must give written informed consent before the baby can join the study.

Who Cannot Join the Study?

  • Having a major birth defect (a serious physical problem present at birth that affects major organs or body parts).
  • Having bleeding inside the brain, called intraventricular hemorrhage, that is moderate to severe (grades 2 to 4).
  • Being judged by the doctor to have a very high risk of dying soon, such as a terminal illness with severe acidosis (blood that is very acidic, pH lower than 7.0, lasting more than two hours) or a very slow heart rate (bradycardia, heart beating fewer than 100 times per minute) that continues for more than two hours with low oxygen levels (hypoxia), or having a serious infection present at birth that is not caused by bacteria (congenital non‑bacterial infection).
  • Needing vitamin A given through a vein (parenteral) in a fat‑based liquid (fat emulsion) at doses higher than the recommended amount for standard multivitamin mixtures.
  • Being born early because the mother used smoking, alcohol, illegal drugs, or other substances that can cause birth defects (modifiable risk factors or teratogenic exposures).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Gcrocpyfvtikcm Pwpvjtouhj Sgmuztf Kpbkxmbuy Uwongmmoodse Mdicdoufgq Id Kjjdfh Myfggvzmoaqysxh W Pvwwompn Poznan Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
30.06.2025
Poland Poland
Not recruiting
30.06.2025

Trial locations

Investigated drugs:

RetinolX is a vitamin A‑derived solution that is given by injection (either into a vein or muscle). In this study it is used to raise the amount of retinol in the blood of very early‑born babies, helping to support normal growth and development. The researchers are watching how the infants’ bodies handle the medicine and are checking for any side effects while the babies grow from birth up to about 36 weeks after conception. The goal is to see if the treatment is safe and if it effectively increases the levels of retinol and related proteins in the blood.

Investigated diseases:

Bronchopulmonary Dysplasia – Bronchopulmonary Dysplasia is a long‑term lung condition that occurs in babies born very early. The lungs are underdeveloped and can become inflamed and scarred after they are exposed to oxygen or breathing support. As the infant grows, the airways may stay narrow and the lung tissue may become less stretchy. This can cause the baby to need extra oxygen or breathing help for weeks or months after birth. Over time the breathing problems may lessen, but the condition can continue to affect lung function into childhood.

Trial ID:
2024-516994-59-00
Protocol code:
ASP-RET-CT001
Trial Phase:
Therapeutic exploratory (Phase II)

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