The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of PregnancyNCT04563429
Vitamin A for BPD Prevention
A study testing Oral Vitamin A in people with The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy, run by Sheba Medical Center.
Trial summary
Chronic bronchopulmonary dysplasia (BPD) is a very common complication in preterm infants born at a young gestational age, and is a serious disease that impairs respiratory long-term outcome and is associated with higher-frequency neurodevelopmental injury. Read more about this study
- Who is it for?
- Ages 2 to 5 days
- Conditions the study is for
- The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy
- What is being tested?
- Oral Vitamin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature babies under 29 weeks, at any birth weight
- A preterm baby is less than 4 days to life
Who cannot join
- Major congenital malformations
- Known chromosomal disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Vitamin A Oral Supplementation as a Preventive Treatment for Chronic Lung Disease Among Infants Born Before 29 Weeks of Gestation.
Chronic bronchopulmonary dysplasia (BPD) is a very common complication in preterm infants born at a young gestational age, and is a serious disease that impairs respiratory long-term outcome and is associated with higher-frequency neurodevelopmental injury. Lowering the incidence of BPD may improve the health of the preterm babies and neurodevelopmental delay of preterm infants.Vitamin A deficiency may be one of the factors associated with the development of BPD in preterm infants. According to the literature, oral vitamin A administration can lower the incidence of BPD. In our study we plan to give 5000 units of retinol / dose / day, every day for 28 days.
- Being tested
- Oral Vitamin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Vitamin ADietary supplement
Oral administration of 5000 EU of Vitamin A during first 28 days of life
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Dietary Supplement: Oral Vitamin A |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of BPD at 28 days
Chronic pulmonary desease of prematue babies
Measured: 28 days of life
Incidence of mortality at 28 days
Death before 28 days of life
Measured: 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Leah Leibovitch MD, Sheba Medical Center
- Investigators
- Leah Leibovich, MD, Principal investigator, Chaim Sheba Medical Center, Tel Hashomer, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563429
- Sponsor's protocol ID
- SHEBA-20-7281-LL-CTIL
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin A Oral Supplementation as a Preventive Treatment for Chronic Lung Disease Among Infants Born Before 29 Weeks of Gestation.
- ClinicalTrials.gov ID
- NCT04563429
- Acronym / sponsor ID
- SHEBA-20-7281-LL-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic bronchopulmonary dysplasia (BPD) is a very common complication in preterm infants born at a young gestational age, and is a serious disease that impairs respiratory long-term outcome and is associated with higher-frequency neurodevelopmental injury. Lowering the incidence of BPD may improve the health of the preterm babies and neurodevelopmental delay of preterm infants.Vitamin A deficiency may be one of the factors associated with the development of BPD in preterm infants. According to the literature, oral vitamin A administration can lower the incidence of BPD. In our study we plan to give 5000 units of retinol / dose / day, every day for 28 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: Oral Vitamin A |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 2 to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Premature babies under 29 weeks, at any birth weight
- A preterm baby is less than 4 days to life
Key exclusion criteria (2 listed)
- Major congenital malformations
- Known chromosomal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Vitamin AOral administration of 5000 EU of Vitamin A during first 28 days of life | Dietary supplement | Treatment Group |
Primary outcome
Incidence of BPD at 28 days
Time frame: 28 days of life
Chronic pulmonary desease of prematue babies
Incidence of mortality at 28 days
Time frame: 28 days of life
Death before 28 days of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Leibovich, MD principal investigator
Chaim Sheba Medical Center, Tel Hashomer, Israel
Questions about this trial
What is this clinical trial studying?
A study testing Oral Vitamin A in people with The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leah Leibovitch, MD (+972526667325, leah.leibovitch@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of BPD at 28 days (time frame: 28 days of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.