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

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Huiqing Sun
• Collaborator: Zhengzhou University
• Treatments: Retinol palmitate; Vitamin A; Vitamins

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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