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The Efficacy and Safety of Early Vitamin AD Supplementation in Very Preterm Infants

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ClinicalTrials.gov Identifier: NCT03779776
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Children’s Hospital of Nanjing Medical University
Information provided by (Responsible Party):
Huiqing Sun, Zhengzhou Children's Hospital, China

Brief Summary:

Bronchopulmonary dysplasia (BPD) is the most prevalent longterm morbidity among surviving extremely preterm infants and has a multifactorial etiology. BPD is associated with later risk of reactive airways disease, such as asthma, post neonatal mortality and adverse neurodevelopmental outcomes.Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and a major cause of vision impairment or blindness in preterm infants, even with aggressed current standard care.Accumulating epidemiologic evidence suggests that vitamin D (VD) deficiency or insufficiency is associated with respiratory disease in children.Vitamin A (VA) plays an integral part in lung growth and differentiation. VA is an essential micronutrient for normal visual function.

Our prospective multicenter double-blinded randomized controlled trial will include infants born at <32 weeks' gestation and admitted to one of 2 tertiary NICUs in China. Infants in the intervention (vitamin AD drops) group will receive the daily dose VA at 1500 IU/day with VD 500 IU/day, added to their enteral feeds in drop form as soon as minimal feeding was introduced, and continued to 28 days or discharge. Infants in the control group will receive an equivalent volume of a placebo solution. Following informed consent, enrolled infants will be randomly allocated to the control or VAD group. The primary outcome is bronchopulmonary dysplasia (BPD) or ROP, and the secondary outcomes are mortality; NEC ≥ stage 2; ; late-onset sepsis; weight gain, change in weight, increase in length, increase in head circumference; time to full enteral feeds; and number and type of critical incident reports.


Condition or disease Intervention/treatment Phase
Efficacy and Safety Other: Vitamin AD Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 976 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Department of Neonatology, Zhengzhou Children's Hospital
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 28, 2020
Estimated Study Completion Date : June 28, 2020

Arm Intervention/treatment
Experimental: Vitamin AD
In Vitamin AD group, the very preterm infants will receive the daily vitamin AD with vitamin A at2000 IU/day and vitamin D at 700 IU/day in drop form added to their enteral feeds when minimal feeding is introduced, and continue to 28 days or discharge. In this group ,the patient also will receive standard intravenous multivitamin preparation (1 mL/kg/d, containing VA 230 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg.
Other: Vitamin AD
In Vitamin AD group, the very preterm infants will receive the daily vitamin AD with vitamin A at2000 IU/day and vitamin D at 700 IU/day in drop form added to their enteral feeds when minimal feeding is introduced, and continue to 28 days or discharge. In this group ,the patient also will receive standard intravenous multivitamin preparation (1 mL/kg/d, containing VA 230 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg.

Placebo Comparator: Control
In this group ,the patient will only receive standard intravenous multivitamin preparation (1 mL/kg/d, containing VA 230 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg.
Other: Control
In this group ,the patient will only receive standard intravenous multivitamin preparation (1 mL/kg/d, containing VA 230 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg.




Primary Outcome Measures :
  1. rates of bronchopulmonary dysplasia [ Time Frame: 1 year ]
    The rates of bronchopulmonary dysplasia with early vitamin AD supplementation

  2. rates of retinopathy of prematurity [ Time Frame: 1 year ]
    The rates of retinopathy of prematurity with early vitamin AD supplementation


Secondary Outcome Measures :
  1. rates of Necrotizing enterocolitis [ Time Frame: 1 year ]
    The rates of Necrotizing enterocolitis with early vitamin AD supplementation


Other Outcome Measures:
  1. rates of late-onset sepsis [ Time Frame: 1 year ]
    The rates of late-onset sepsis with early vitamin AD supplementation



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Ages Eligible for Study:   up to 96 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gestational age<32 weeks,
  • <96 hours of age

Exclusion Criteria:

  • genetic metabolic diseases;
  • congenital major abnormalities;
  • congenital non-bacterial infection with overt signs at birth;
  • terminal stage of illness (pH < 7.0 or hypoxia with bradycardia>2 h);
  • ≥ grade III intracranial hemorrhage;
  • lacking parental consent.

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): NCT03779776


Contacts
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Contact: Huiqing Sun, PhD 86-0371-85515913 s_huiqing@sina.com

Locations
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China, Henan
Zhengzhou Children's Hospital Recruiting
Zhengzhou, Henan, China, 450018
Contact: Huiqing Sun, PhD    86-0371-85515913    s_huiqing@sina.com   
Sponsors and Collaborators
Zhengzhou Children's Hospital, China
Children’s Hospital of Nanjing Medical University
Investigators
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Study Director: Shuying Luo, MD Zhengzhou Children's Hospital

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Responsible Party: Huiqing Sun, Vice Director of Neonatology department, Zhengzhou Children's Hospital, China
ClinicalTrials.gov Identifier: NCT03779776     History of Changes
Other Study ID Numbers: VAD-PRETERM
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
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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Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs