Effects of Early Vitamin A Supplementation on the Risk for Retinopathy of Prematurity in Extremely Preterm Infants

NCT03154723 | Completed DMC

• 1 other identifier: VitA-ROP
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and major cause of vision impairment or blindness, despite current treatment of late stage ROP. Because the visual disorders after treatment are often poor, preventive therapy for ROP is still lacking. Although ROP is a multifactorial disease, the altered regulation of vascular endothelial growth factor (VEGF) and insulin-like growth factor (IGF-1) have been implicated in the pathogenesis of ROP. Vitamin A is one of the most important micronutrients affecting the health of children. Supplementing newborn infants with vitamin A within the first 2 days of life reduced infant mortality by almost 25%, with the greatest benefit to those of low birth weight. Vitamin A has been used in this population prophylactically for chronic lung disease with the large doses and no reported significant adverse effect exists. It is suggested that vitamin A-retinoids and their active metabolite, retinoic acid (RA) have highly potent antiangiogenic activity by inhibiting VEGF expression. Vitamin A (retinol) is converted into retinoic acid in cells. However, the significance of Vitamin A administration has not been investigated to our knowledge in an experimental ROP infant. The aim of this study was to perform prospective, multicenter, randomized design to demonstrate the preventive effect of Vitamin A on ROP.

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

• The rates of Retinopathy of Prematurity

  2 years

Study Arms (1)

Vitamin A Group

EXPERIMENTAL

In vitamin A group, The extremely preterm infants will be given the daily dose 1500 IU/day in drop form added to their enteral feeds as soon as minimal feeding is introduced.The duration of vitamin A supplementation was 28 days.

Drug: Vitamin A

Interventions

Vitamin A DRUG

Vitamin A daily dose 1500IU/day will be added to infant's enteral feeds in drop form as soon as minimal feeding is introduced. The vitamin A supplementation was last for 28 days.

Also known as: Retinoic acid

Vitamin A Group

Eligibility Criteria

• Age: 1 Hour - 45 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• gestational age \<28 weeks, \<72 h of age, receiving mechanical ventilation, noninvasive respiratory support or supplemental oxygen (FiO2\>0.21) at 24h of age.

You may not qualify if:

• genetic metabolic diseases, congenital abnormalities, congenital nonbacterial infection with overt signs at birth, terminal illness as evidenced by PH\<7.0 for \>2h or persistent bradycardia (heart rate \<100 bpm) associated with hypoxia for \>2h, or grade III or IV intracranial hemorrhage before randomization were excluded

Sponsors & Collaborators

• Huiqing Sun: lead
• Zhengzhou University: collaborator

Study Sites (1)

Zhengzhou Children's Hospital

Zhengzhou, Henan, 450018, China

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Vitamin A; Tretinoin

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Ligong Hou, MD

  Chidren's Hospital of Zhengzhou

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The director of neonatal intensive care unit

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: May 16, 2017
• Study Start: August 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)