Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants

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Brief Title

Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants

Official Title

Randomized Trial of Vitamin A Supplementation for Extremely-Low-Birth-Weight

Brief Summary

      This multi-site, randomized trial was conducted to determine the safety and effectiveness of
      a higher dose of vitamin A and determine if this would increase the rate of survival without
      bronchopulmonary dysplasia (BPD) and reduce the risk of sepsis. Infants with birth weights
      from 401-1000g and who were on mechanical ventilation or supplemental oxygen at 24-96 hours
      of age were enrolled. Subjects were randomized to either the Vitamin A or a control group.
      Infants in the Vitamin A group were given a dose of 5000 IU (0.1 ml) intramuscularly on
      Mondays, Wednesdays, and Fridays for four weeks. Control infants received a sham procedure
      rather than placebo injections.
    

Detailed Description

      Infants with extremely low birth weights (≤1,000 g) have low plasma and tissue concentrations
      of vitamin A, and vitamin A deficiency may predispose these infants to chronic lung disease.
      A meta-analysis of clinical trials of vitamin A supplementation for preterm infants revealed
      a 17% increase in the rate of survival without chronic lung disease, which approached
      statistical significance.

      This multi-site, randomized trial was conducted to determine the safety and effectiveness of
      a higher dose of vitamin A than that used in previous trials in extremely-low-birth-weight
      (ELBW) infants. We hypothesized that vitamin A supplementation would increase the rate of
      survival without bronchopulmonary dysplasia and reduce the risk of sepsis.

      Infants with birth weights from 401-1000g and who received mechanical ventilation or
      supplemental oxygen at 24-96 hours of age were enrolled. Subjects were randomized to either
      the vitamin A or a control group. Infants in the Vitamin A group were given a dose of 5000 IU
      (0.1 ml) intramuscularly on Mondays, Wednesdays, and Fridays for four weeks. Control infants
      received a sham procedure rather than placebo injections.

      Serum vitamin A was measured in a central laboratory at base line and at 28 days in the first
      300 infants. On study day 28 (two to three days after the last treatment and immediately
      after a blood sample was collected), the relative dose-response was evaluated.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Chronic lung disease or death

Secondary Outcome

 Sepsis

Condition

Infant, Newborn

Intervention

Vitamin A

Study Arms / Comparison Groups

 Experimental
Description:  Vitamin A group.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

807

Start Date

January 1996

Completion Date

July 1999

Primary Completion Date

July 1997

Eligibility Criteria

        Inclusion Criteria:

          -  Infants wtih birth weights from 401-1,000g

          -  Receiving mechanical ventilation or supplemental oxygen at 24-96 hours of age

        Exclusion Criteria:

          -  Major congenital anomalies

          -  Congenital nonbacterial infection

          -  Infants diagnosed with a terminal illness (as indicated by a pH below 6.80 or by the
             presence of hypoxia with bradycardia for more than two hours)

          -  Infants who were to receive vitamin A in a parenteral fat emulsion or in doses
             exceeding recommendations for multivitamin preparations
      

Gender

All

Ages

N/A - 96 Hours

Accepts Healthy Volunteers

No

Contacts

Jon E. Tyson, MD MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01203488

Organization ID

NICHD-NRN-0015

Secondary IDs

U10HD021373


Study Sponsor

NICHD Neonatal Research Network

Collaborators

 National Center for Research Resources (NCRR)

Study Sponsor

Jon E. Tyson, MD MPH, Study Director, University of Texas Southwestern Medical Center


Verification Date

September 2017