Clinical trial NCT03779776: The Efficacy and Safety of Early Vitamin AD Supplementation in Very Preterm Infants
Official title: The Department of Neonatology, Zhengzhou Children's Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Efficacy and Safety
Lead sponsor: Zhengzhou Children's Hospital, China
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 676
Sex: ALL
Minimum age (years): 1
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility 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.

Primary outcomes:
measure: rates of bronchopulmonary dysplasia
timeFrame: 1 year
measure: rates of retinopathy of prematurity
timeFrame: 1 year
measure: Metaboloc bone disease
timeFrame: 1 year
Secondary outcomes:
measure: rates of Necrotizing enterocolitis
timeFrame: 1 year
Other outcomes:
measure: rates of late-onset sepsis
timeFrame: 1 year
Locations:
city: Zhengzhou
country: China
facility: Zhengzhou Children's Hospital
state: Henan
Study officials:
affiliation: Zhengzhou Children's Hospital
name: Shuying Luo, MD
role: STUDY_DIRECTOR
References: