Research

SAMPLE Evidence Analysis Library® Worksheet Template

Citation

Kiatchoosakun P, Jirapradittha J, Panthongviriyakul MC et al. Vitamin A supplementation for prevention of bronchopulmonary dysplasia in very-low-birth- weight premature Thai infants: a randomized trial. J Med Assoc Thai. 2014;97:S82- 88.

Study Design Randomized controlled trial

Class A

Quality Rating + (Positive)

Research Purpose To determine whether vitamin A supplementation prevents bronchopulmonary dysplasia (BPD) in very low birth weight (VLBW) preterm infants.

Inclusion Criteria

 Premature infants

 Weight <1500g

 Requirement of supplementation oxygen at 24hours of age

Exclusion Criteria

 Major congenital abnormalities

 Congenital (non-bacterial) infections

 Terminal illness

 pH < 6.80 or hypoxia with bradycardia >2 hours

Description of Study Protocol

 Recruitment: Infants admitted to Neonatal Unit; enrolled 24-96 hours after birth.

 Design: Randomized to vitamin A group or control group

 Blinding used (if applicable): Research nurse provided either injection (to vitamin A group) or sham procedure (to control group); all others blinded to group assignment

 Intervention (if applicable): Vitamin A (5,000 IU, 0.1mL) injection Mondays, Wednesdays, and Fridays for four weeks.

 Statistical Analysis: Student’s t-test, Chi-squared test, and Fisher’s exact test were used to compare groups. p-values of <0.05 were considered statistically significant. Relative risks (RR) with 95% confidence intervals (CI) were noted.

Data Collection Summary

 Timing of Measurements: Baseline and 36 weeks postmenstrual age; blood samples taken at baseline and day 7, 14, and 28.

 Dependent Variables: Primary outcomes measured were BPD (defined as supplemental oxygen requirement at 36 weeks postmenstrual age) and sepsis (defined by positive blood culture and antibiotic treatment >5 days)

 Independent Variables: Vitamin A supplementation

 Control Variables: Vitamins and enteral feedings were recorded; infants were routinely assessed for signs of vitamin A toxicity.

Description of Actual Data Sample

 Initial: 80 (41 Males, 39 Females)

 Attrition (final N): 80

 Age: Premature infants, enrolled 24-96 hours after birth

 Ethnicity: Assumed Thai (not specified)

 Other relevant demographics: N/a

 Anthropometrics: Mean birth weights of 1,152.8 ± 206.3g (vitamin A group) and 1,123.1 ± 218.1g (control group)

 Location: Srinagarind Hospital, Khon Kaen University (Thailand)

Summary of Results

Key Findings: Vitamin A supplementation associated with:

 Non-significant reduction in BPD incidence (22.5 versus 35% RR 0.71; 95% CI 0.40-1.26; p = 0.21)

Other Findings: Vitamin A supplementation associated with:

 Significant reductions in duration of intubation (p = 0.03) and length of stay (p = 0.002)

 Non-significant reductions in retinopathy of prematurity (ROP)(p = 0.07), nosocomial sepsis (p = 0.43), patent ductus arteriosus (PDA) (p = 0.37), necrotizing enterocolitis (NEC) (p = 0.57)

Author Conclusion

Vitamin A supplementation significantly reduced duration of intubation and hospital LOS, and should be administered routinely to preterm infants requiring respiratory support or oxygen therapy.

Reviewer Comments

Limitations: Small sample size

Funding Source Grant support via Khon Kaen University

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