Original Articles
A comparison of three vitamin a dosing regimens in extremely-low-birth-weight infants

Presented in part at the Pediatric Academic Societies' Meeting, Baltimore, Maryland, May 2002.
https://doi.org/10.1067/mpd.2003.214Get rights and content

Abstract

Objective Vitamin A supplementation reduces bronchopulmonary dysplasia (BPD)/death in extremely low birth weight neonates. It was hypothesized that compared with the standard regimen of 5000 IU 3 times per week for 4 weeks, (1) a higher dose (10,000 IU 3 × per week) would increase serum retinol and retinol binding protein (RBP) and lower relative dose responses (RDR), and (2) once-per-week dosing (15,000 IU once per week) would lead to equivalent levels, RBP, and RDR. Study design Extremely low birth weight neonates (n = 120) receiving O2/mechanical ventilation at 24 hours were randomly assigned to (1) standard, (2) higher dose, or (3) once-per-week regimens. Measures of vitamin A deficiency were serum retinol <20 μg/dL, RBP <2.5 mg/dL, and/or RDR >10% on day 28. BPD was defined as O2/mechanical ventilation at 36 weeks' postmenstrual age. Results Groups were similar at enrollment (median gestational age, 25 weeks; birth weight, 689 g). Possible toxicity was seen in <5%. The higher dose regimen did not increase retinol or RBP, decrease RDR, or improve outcomes. Infants in the once-per-week regimen had lower retinol levels and higher RDR without an effect on outcomes. Conclusions Compared with the standard regimen, once-per-week dosing worsened, and higher doses did not reduce, vitamin A deficiency. Therefore, the standard regimen is recommended. (J Pediatr 2003;142:656-61)

Section snippets

Methods

This study was a randomized, partially masked trial comparing the standard, the higher dose, and the once-per-week regimens. The protocol was approved by the institutional review board, and informed parental consent was obtained before random assignment. The study design was similar to the NICHD Neonatal Network trial with respect to entry criteria, ages at retinol administration, and biochemical and clinical assessment methods (Tyson et al, 1999). Entry criteria were birth weight 401 to 1000 g

Results

ELBW infants (n = 120) were enrolled in the trial from November 1999 to August 2001. A total of 269 ELBW infants were screened for eligibility during this period, and 190 (71%) were found eligible. Of the remaining 79 infants (29%), 55 (20%) were not eligible because they were not receiving mechanical ventilation or supplemental oxygen at 24 hours of age, 22 (8%) died, and 2 had major malformations. Informed consent was obtained in 120 of the 190 infants (63%). Consent was declined by parents

Discussion

This study evaluated three regimens for the intramuscular administration of vitamin A in ELBW neonates. Compared with the standard NICHD regimen (5000 IU 3 × per week for 4 weeks), administration of a higher dose (10,000 IU 3 × per week for 4 weeks) did not increase vitamin A concentrations or reduce biochemical measures of deficiency, whereas once-per-week dosing (15,000 IU once per week for 4 weeks) led to lower retinol concentrations on study day 28.

A limitation of this study is that blood

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Reprints not available from the authors. Address correspondence to: Namasivayam Ambalavanan, MD, 525 New Hillman Bldg, 619 S 19th St, University of Alabama at Birmingham, Birmingham, AL 35249. E-mail: [email protected] .

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