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

NCT03779776 | Completed

• 1 other identifier: VAD-PRETERM
• Study Type: interventional
• Target: 676
• Locations: 1 country
• Sites: 1

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.

Conditions

Efficacy and Safety

Outcome Measures

Primary Outcomes (3)

• rates of bronchopulmonary dysplasia

  The rates of bronchopulmonary dysplasia with early vitamin AD supplementation

  1 year

• rates of retinopathy of prematurity

  The rates of retinopathy of prematurity with early vitamin AD supplementation

  1 year

• Metaboloc bone disease

  The rates of Metaboloc bone disease of prematurity with early vitamin AD supplementation

  1 year

Secondary Outcomes (1)

• rates of Necrotizing enterocolitis

  1 year

Other Outcomes (1)

• rates of late-onset sepsis

  1 year

Study Arms (2)

Vitamin AD

EXPERIMENTAL

In Vitamin AD group, the very preterm infants will receive the daily vitamin AD with vitamin A at1500 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.

Other: Vitamin AD

Control

PLACEBO COMPARATOR

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.

Other: Control

Interventions

Vitamin AD OTHER

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.

Vitamin AD

Control OTHER

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.

Control

Eligibility Criteria

• Age: 1 Hour - 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhengzhou Children's Hospital, China: lead

Study Sites (1)

Zhengzhou Children's Hospital

Zhengzhou, Henan, 450018, China

Location

Study Officials

• Shuying Luo, MD

  Zhengzhou Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Neonatology department

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 19, 2018
• Study Start: July 1, 2018
• Primary Completion: June 28, 2020
• Study Completion: June 28, 2020
• Last Updated: September 10, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)