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

Efficacy and Safety Clinical Trial

Official title:

The Department of Neonatology, Zhengzhou Children's Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779776
• Other study ID #: VAD-PRETERM
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 28, 2020

Study information

• Verified date: October 2020
• Source: Zhengzhou Children's Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and metabolic bone disease in premature children.Vitamin A (VA) plays an integral part in lung growth and differentiation. VA is an essential micronutrient for normal visual function.

Our prospective double-blinded randomized controlled trial will include infants born at <32 weeks' gestation and admitted to six 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) , ROP, or metabolic bone disease 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 676
• Est. completion date: June 28, 2020
• Est. primary completion date: June 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 96 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy and Safety

Intervention

Other:
• Vitamin AD
In Vitamin AD group, the very preterm infants will receive the daily vitamin AD with vitamin A at 1500 IU/day and vitamin D at 500 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, VD 80 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg.
• Control
In this group ,the patient will only receive standard intravenous multivitamin preparation (1 ml/kg/d,containing VA 230 IU/kg/d, VD 80 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg.

Locations

Country	Name	City	State
China	Zhengzhou Children's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhengzhou Children's Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rates of late-onset sepsis	The rates of late-onset sepsis with early vitamin AD supplementation	1 year
Primary	rates of bronchopulmonary dysplasia	The rates of bronchopulmonary dysplasia with early vitamin AD supplementation	1 year
Primary	rates of retinopathy of prematurity	The rates of retinopathy of prematurity with early vitamin AD supplementation	1 year
Primary	Metaboloc bone disease	The rates of Metaboloc bone disease of prematurity with early vitamin AD supplementation	1 year
Secondary	rates of Necrotizing enterocolitis	The rates of Necrotizing enterocolitis with early vitamin AD supplementation	1 year