NCT01193270

Brief Summary

The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and less than 1000 grams birth weight). This pilot will examine whether a single dose of vitamin E will be absorbed into the infants' bloodstreams with resulting serum α-tocopherol level in the target range of 1-3 mg/dl.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

10 months

First QC Date

August 31, 2010

Last Update Submit

November 10, 2015

Conditions

Infant, NewbornInfant, Small for Gestational AgeInfant, Very Low Birth WeightInfant, PrematureIntracranial Hemorrhages

Keywords

NICHD Neonatal Research NetworkIntraventricular Hemorrhage (IVH)Very Low Birth Weight (VLBW)Extremely Low Birth Weight (ELBW)Prematurity

Outcome Measures

Primary Outcomes (1)

  • Serum tocopherol levels

    Blood samples will be tested for tocopherol levels at baseline, 24 hours, and 7 days.

    Birth to 7 days

Study Arms (2)

Vitamin E

EXPERIMENTAL

A single intragastric dose of dl-α-tocopheryl acetate (Aquasol E®) 50 IU/kg.

Drug: Vitamin E

Placebo

PLACEBO COMPARATOR

Sterile water in volume equal to that of the comparator drug.

Drug: Placebo

Interventions

Vitamin EDRUG

A single intragastric dose of dl-α-tocopheryl acetate 50 IU/kg.

Also known as: Aquasol E®
Vitamin E
PlaceboDRUG

Sterile water in volume equal to that of the comparator drug

Placebo

Eligibility Criteria

AgeUp to 4 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Less than 27 completed weeks gestational age
  • Birth weight less than 1,000 grams
  • Inborn infants

You may not qualify if:

  • Infant's treatment will be limited based on poor prognosis
  • Umbilical cord or blood pH below 7.0
  • Antenatally diagnosed brain abnormality, including hemorrhage
  • Major congenital malformations, including those for which feeding is contraindicated
  • Mother of infant enrolled in a clinical trial of vitamin E supplementation
  • Mother of infant reports self administration of monovitamin supplements of vitamin E during pregnancy or labor
  • Infant has received supplemental vitamin E (except multivitamin additive in parenteral nutrition or through enteral milk or formula feeds)
  • Greater than four hours of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

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

Cleveland, Ohio, 44106, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

  • Bell EF, Hansen NI, Brion LP, Ehrenkranz RA, Kennedy KA, Walsh MC, Shankaran S, Acarregui MJ, Johnson KJ, Hale EC, Messina LA, Crawford MM, Laptook AR, Goldberg RN, Van Meurs KP, Carlo WA, Poindexter BB, Faix RG, Carlton DP, Watterberg KL, Ellsbury DL, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Serum tocopherol levels in very preterm infants after a single dose of vitamin E at birth. Pediatrics. 2013 Dec;132(6):e1626-33. doi: 10.1542/peds.2013-1684. Epub 2013 Nov 11.

    PMID: 24218460RESULT

Related Links

MeSH Terms

Conditions

Premature BirthIntracranial Hemorrhages

Interventions

Vitamin ETocopherols

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Abbot R. Laptook, MD

    Brown University, Women & Infants Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

  • Michele C. Walsh, MD MS

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

    PRINCIPAL INVESTIGATOR

  • Ronald N. Goldberg, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Barbara J. Stoll, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Brenda B. Poindexter, MD MS

    Indiana University

    PRINCIPAL INVESTIGATOR

  • Abhik Das, PhD

    RTI International

    PRINCIPAL INVESTIGATOR

  • Krisa P. Van Meurs, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Ivan D. Frantz, III, MD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

  • Waldemar A. Carlo, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Edward F. Bell, MD

    University of Iowa

    STUDY CHAIR

  • Kristi L. Watterberg, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

  • Pablo J. Sanchez, MD

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

  • Kathleen A. Kennedy, MD MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

  • Roger G. Faix, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

  • Seetha Shankaran, MD

    Wayne State University

    PRINCIPAL INVESTIGATOR

  • Richard A. Ehrenkranz, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 1, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

US(16)