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Trial record 27 of 293 for:    retinopathy of prematurity

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

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ClinicalTrials.gov Identifier: NCT03154723
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
Zhengzhou University
Information provided by (Responsible Party):
Huiqing Sun, Zhengzhou Children's Hospital, China

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.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Drug: Vitamin A Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017


Arm Intervention/treatment
Experimental: Vitamin A Group
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
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.
Other Name: Retinoic acid




Primary Outcome Measures :
  1. The rates of Retinopathy of Prematurity [ Time Frame: 2 years ]


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Ages Eligible for Study:   up to 45 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154723


Locations
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China, Henan
Zhengzhou Children's Hospital
Zhengzhou, Henan, China, 450018
Sponsors and Collaborators
Huiqing Sun
Zhengzhou University
Investigators
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Study Chair: Ligong Hou, MD Chidren's Hospital of Zhengzhou

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Responsible Party: Huiqing Sun, The director of neonatal intensive care unit, Zhengzhou Children's Hospital, China
ClinicalTrials.gov Identifier: NCT03154723     History of Changes
Other Study ID Numbers: VitA-ROP
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Obstetric Labor, Premature
Infant, Premature, Diseases
Eye Diseases
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents