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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

807 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

1999-07-31

Brief Summary

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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

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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.

Conditions

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Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Bronchopulmonary Dysplasia Respiration, Artificial Respiratory Distress Syndrome, Newborn Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Experimental

Vitamin A group.

Group Type EXPERIMENTAL

Vitamin A

Intervention Type DRUG

5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks.

Control

Sham procedure Control group.

Group Type SHAM_COMPARATOR

Sham Procedure

Intervention Type OTHER

Control infants received a sham procedure rather than placebo injections.

Interventions

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Vitamin A

5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks.

Intervention Type DRUG

Sham Procedure

Control infants received a sham procedure rather than placebo injections.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

24 Hours

Maximum Eligible Age

96 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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University of Texas Southwestern Medical Center

Principal Investigators

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Jon E. Tyson, MD MPH

Role: STUDY_DIRECTOR

University of Texas Southwestern Medical Center

William Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University, Women and Infants Hospital

Joel Verter, PhD

Role: PRINCIPAL_INVESTIGATOR

George Washington University Biostatistics Center

Richard A. Ehrenkranz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Barbara J. Stoll, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

James A. Lemons, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

David K. Stevenson, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Charles R. Bauer, MD

Role: STUDY_DIRECTOR

University of Miami

Sheldon B. Korones, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Edward F. Donovan, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

University of Tennessee

Memphis, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Stark AR, Tyson JE, Hibberd PL. Variation among institutional review boards in evaluating the design of a multicenter randomized trial. J Perinatol. 2010 Mar;30(3):163-9. doi: 10.1038/jp.2009.157. Epub 2009 Oct 1.

Reference Type BACKGROUND

PMID: 19798046 (View on PubMed)

Kennedy KA, Stoll BJ, Ehrenkranz RA, Oh W, Wright LL, Stevenson DK, Lemons JA, Sowell A, Mele L, Tyson JE, Verter J. Vitamin A to prevent bronchopulmonary dysplasia in very-low-birth-weight infants: has the dose been too low? The NICHD Neonatal Research Network. Early Hum Dev. 1997 Jul 24;49(1):19-31. doi: 10.1016/s0378-3782(97)01869-0.

Reference Type RESULT

PMID: 9179535 (View on PubMed)

Tyson JE, Wright LL, Oh W, Kennedy KA, Mele L, Ehrenkranz RA, Stoll BJ, Lemons JA, Stevenson DK, Bauer CR, Korones SB, Fanaroff AA. Vitamin A supplementation for extremely-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med. 1999 Jun 24;340(25):1962-8. doi: 10.1056/NEJM199906243402505.

Reference Type RESULT

PMID: 10379020 (View on PubMed)

Ambalavanan N, Tyson JE, Kennedy KA, Hansen NI, Vohr BR, Wright LL, Carlo WA; National Institute of Child Health and Human Development Neonatal Research Network. Vitamin A supplementation for extremely low birth weight infants: outcome at 18 to 22 months. Pediatrics. 2005 Mar;115(3):e249-54. doi: 10.1542/peds.2004-1812. Epub 2005 Feb 15.

Reference Type RESULT

PMID: 15713907 (View on PubMed)

Rysavy MA, Li L, Tyson JE, Jensen EA, Das A, Ambalavanan N, Laughon MM, Greenberg RG, Patel RM, Pedroza C, Bell EF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Should Vitamin A Injections to Prevent Bronchopulmonary Dysplasia or Death Be Reserved for High-Risk Infants? Reanalysis of the National Institute of Child Health and Human Development Neonatal Research Network Randomized Trial. J Pediatr. 2021 Sep;236:78-85.e5. doi: 10.1016/j.jpeds.2021.05.022. Epub 2021 May 15.

Reference Type DERIVED

PMID: 34004189 (View on PubMed)