Vitamin A for BPD Prevention | NCT04563429

Studies
Vitamin A for BPD Prevention

NCT04563429

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Sep 24, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy

Interventions

Oral Vitamin A

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Estimated

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Oct 1, 2023Estimated

First Submitted Date

Sep 22, 2020

First Submission Date that Met QC Criteria

Sep 22, 2020

First Posted Date

Sep 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2020

Last Update Posted Date

Sep 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Experimental		Dietary Supplement: Oral Vitamin A
Control Group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral Vitamin A	Dietary Supplement	Oral administration of 5000 EU of Vitamin A during first 28 days of life	Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of BPD at 28 days	Chronic pulmonary desease of prematue babies	28 days of life
Incidence of mortality at 28 days	Death before 28 days of life	28 days of life

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Premature babies under 29 weeks, at any birth weight
A preterm baby is less than 4 days to life

Exclusion Criteria:

Major congenital malformations
Known chromosomal disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Days

Maximum Age

5 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leah Leibovitch, MD	Contact	+972526667325		leah.leibovitch@sheba.health.gov.il
Liudmila Lo Schiavo Winer, MD	Contact	+972503367233		Liudmila.LoSchiavo@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Leah Leibovich, MD	Chaim Sheba Medical Center, Tel Hashomer, Israel	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014801	Vitamin A

Ancestor Terms

ID	Term
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839

Browse Leaves

Not provided

Browse Branches

Not provided