NCT00874393

Brief Summary

This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months. Eligible infants will receive an infusion drug (dopamine or a dextrose placebo) and a syringe drug (hydrocortisone or a normal saline placebo). Enrolled infants will be randomized to receive one of the following drug pairs:

  • dopamine and hydrocortisone
  • dopamine and normal saline
  • dextrose and hydrocortisone
  • dextrose and normal saline. In addition to the intervention above, the NRN is conducting a 6-month time-limited prospective observational study of all infants born at an NRN center between 23 and 26 weeks gestational age. All clinical decisions made for these babies will be at the discretion of the attending neonatologist/infant care team according to standard practice at each institution. Data on blood pressure management in the first 24 postnatal hours collected for each infant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2009

Typical duration for phase_1

Geographic Reach
1 country

17 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

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

April 1, 2009

Last Update Submit

May 23, 2017

Conditions

Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, PrematureHypotensionBlood Pressure

Keywords

NICHD Neonatal Research NetworkVery Low Birth Weight (VLBW)Extremely Low Birth Weight (ELBW)PrematurityBlood Pressure ManagementDopamineHydrocortisone

Outcome Measures

Primary Outcomes (1)

  • Enrollment and completion of 60 infants

    1 year

Secondary Outcomes (6)

  • Death

    1 week and prior to hospital discharge

  • Duration of antihypotensive therapy

    First 96 postnatal hours

  • Receipt and timing of medical and/or surgical therapy for a PDA

    To hospital discharge

  • Use of open-label antihypotensive therapies (inotropes, corticosteroids, blood and plasma volume expanders) for persistently low BP with biochemical evidence of poor perfusion

    First 96 postnatal hours

  • Spontaneous gastrointestinal perforation

    First 7 days

  • +1 more secondary outcomes

Study Arms (4)

Dopamine and hydrocortisone

ACTIVE COMPARATOR

Dopamine AND hydrocortisone

Drug: DopamineDrug: Hydrocortisone

Dopamine and placebo

ACTIVE COMPARATOR

Dopamine AND normal saline placebo

Drug: DopamineDrug: Syringe Placebo

Placebo and hydrocortisone

ACTIVE COMPARATOR

Dextrose (D5W) placebo AND hydrocortisone

Drug: HydrocortisoneDrug: Infusion Placebo

Placebo and Placebo

PLACEBO COMPARATOR

Dextrose (D5W) placebo AND normal saline placebo

Drug: Infusion PlaceboDrug: Syringe Placebo

Interventions

DopamineDRUG

Dopamine

Dopamine and hydrocortisoneDopamine and placebo
HydrocortisoneDRUG

Hydrocortisone

Dopamine and hydrocortisonePlacebo and hydrocortisone
Infusion PlaceboDRUG

Dextrose (D5W)

Placebo and PlaceboPlacebo and hydrocortisone
Syringe PlaceboDRUG

Normal saline

Dopamine and placeboPlacebo and Placebo

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Inborn infants
  • /7 to 26 6/7 weeks estimated gestational age
  • Umbilical arterial catheter in place at study entry
  • \<= 24 hours of age

You may not qualify if:

  • Terminally ill infants
  • Infants that have received (prior to enrollment): \>20 ml/kg in fluid boluses, indomethacin, or ibuprofen
  • Infants with major congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

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

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University

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 (3)

  • Batton BJ, Li L, Newman NS, Das A, Watterberg KL, Yoder BA, Faix RG, Laughon MM, Van Meurs KP, Carlo WA, Higgins RD, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Feasibility study of early blood pressure management in extremely preterm infants. J Pediatr. 2012 Jul;161(1):65-9.e1. doi: 10.1016/j.jpeds.2012.01.014. Epub 2012 Feb 14.

    PMID: 22336574RESULT

  • Batton B, Li L, Newman NS, Das A, Watterberg KL, Yoder BA, Faix RG, Laughon MM, Stoll BJ, Higgins RD, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health & Human Development Neonatal Research Network. Early blood pressure, antihypotensive therapy and outcomes at 18-22 months' corrected age in extremely preterm infants. Arch Dis Child Fetal Neonatal Ed. 2016 May;101(3):F201-6. doi: 10.1136/archdischild-2015-308899. Epub 2015 Nov 13.

    PMID: 26567120DERIVED

  • Batton B, Li L, Newman NS, Das A, Watterberg KL, Yoder BA, Faix RG, Laughon MM, Stoll BJ, Van Meurs KP, Carlo WA, Poindexter BB, Bell EF, Sanchez PJ, Ehrenkranz RA, Goldberg RN, Laptook AR, Kennedy KA, Frantz ID 3rd, Shankaran S, Schibler K, Higgins RD, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health & Human Development Neonatal Research Network. Use of antihypotensive therapies in extremely preterm infants. Pediatrics. 2013 Jun;131(6):e1865-73. doi: 10.1542/peds.2012-2779. Epub 2013 May 6.

    PMID: 23650301DERIVED

Related Links

MeSH Terms

Conditions

Premature BirthHypotension

Interventions

DopamineHydrocortisone

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Beau J. Batton, MD

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

    PRINCIPAL INVESTIGATOR

  • Ronald N. Goldberg, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Krisa P. Van Meurs, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Waldemar A Carlo, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Kristi L. Watterberg, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

  • Roger G. Faix, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

  • Abhik Das, PhD

    RTI International

    PRINCIPAL INVESTIGATOR

  • Edward F. Bell, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • Abbot R. Laptook, MD

    Brown University

    PRINCIPAL INVESTIGATOR

  • Barbara J. Stoll, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Brenda P. Poindexter, MD MS

    Indiana University

    PRINCIPAL INVESTIGATOR

  • Kurt Schibler, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

  • Kathleen A. Kennedy, MD MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

  • Pablo J. Sanchez, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

  • Seetha Shankaran, MD

    Wayne State University

    PRINCIPAL INVESTIGATOR

  • Richard A. Ehrenkranz, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Ivan D. Franz III, MD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

US(17)