NCT00598429

Brief Summary

This pilot study was a randomized, placebo-controlled, clinical trial to test the safety of using the intravenous form of Prostaglandin E1 (PGE1) in an inhaled form for treatment of hypoxemic respiratory failure in term newborns. The study planned to enroll 50 infants diagnosed with hypoxemic respiratory failure at nine NICHD Neonatal Research Network sites, and randomly assign them to receive one dose over a 72-hour period of either high concentration PGE1 (300 ng/kg/min), low concentration PGE1 (150 ng/kg/min), or placebo (normal saline, the diluent for the drug). In addition to determining the safety, optimal dose, and duration of the therapy, this pilot trial planned to evaluate the feasibility of conducting a larger, multi-center randomized, blinded placebo-controlled trial.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
withdrawn

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

January 10, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 21, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 22, 2019

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

January 10, 2008

Last Update Submit

March 20, 2019

Conditions

Infant, NewbornRespiratory InsufficiencyPulmonary HypertensionRespiratory Distress Syndrome, NewbornStreptococcal Infections

Keywords

NICHD Neonatal Research NetworkHypoxemic respiratory failure (HRF)Persistent pulmonary hypertension of the newborn (PPHN)Prostaglandin E1 (PGE1)Mechanical ventilationMeconium, aspiration

Outcome Measures

Primary Outcomes (1)

  • The ability to recruit an adequate number of patients (n = 50) in a 6-9 month period without excessive (>20%) protocol violations.

    6-9 months after trial begins recruitment

Secondary Outcomes (9)

  • Progression to an OI greater than 25

    72-hours after enrollment

  • Improvement in partial pressure of oxygen (PaO2) in the blood gas

    72-hours after enrollment

  • Change in OI

    72 hours after enrollment

  • Death

    72-hours after intervention

  • Need for inhaled nitric oxide or ECMO

    72-hours after enrollment

  • +4 more secondary outcomes

Study Arms (3)

High dose

ACTIVE COMPARATOR

PGE1 300 ng/kg/min via nebulizer over a 72-hour period

Drug: Inhaled Prostaglandin E1

Low dose

ACTIVE COMPARATOR

PGE1 150 ng/kg/min via nebulizer over a 72-hour period

Drug: Inhaled Prostaglandin E1

Placebo

PLACEBO COMPARATOR

Normal saline, the diluent for the drug, via nebulizer over a 72-hour period

Drug: Inhaled Prostaglandin E1

Interventions

Inhaled Prostaglandin E1DRUG

Delivery of one dose of either high dose PGE1 (300 ng/kg/min), low dose PGE1 (150 ng/kg/min), or placebo (normal saline, the diluent for the drug) via nebulizer over a 72-hour period

Also known as: Alprostadil
High doseLow dosePlacebo

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants born at 34 0/7ths weeks gestational age or greater (by best obstetrical estimate) and at a postnatal age no greater than 7 days (168 hours)
  • Infants diagnosed with hypoxemic respiratory failure (HRF), including perinatal aspiration syndrome (meconium, blood, or amniotic fluid), pneumonia/ sepsis, respiratory distress syndrome, or idiopathic respiratory failure
  • Infants who will receive assisted ventilation for HRF
  • Infants with an oxygenation index (MAP x FiO2 x 100/PaO2)(OI) of 15-25 on two arterial gases taken between 15 minutes and 12 hours apart
  • An indwelling arterial line
  • Infants whose parents/legal guardians have provided consent for enrollment

You may not qualify if:

  • Any infant in whom a decision has been made not to provide full treatment
  • Known structural congenital heart disease, except patent ductus arteriosus and atrial/ventricular level shunts
  • Congenital diaphragmatic hernia
  • Preterm neonates less than 34 weeks
  • Thrombocytopenia (platelet count \< 80,000/μl) unresponsive to platelet transfusion
  • Infants receiving hypothermia for hypoxic ischemic encephalopathy
  • Previous treatment with inhaled nitric oxide
  • Infants already enrolled in a conflicting and/or Investigational New Drug (IND) clinical trial
  • Infants whose parents/legal guardians refuse consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University

Palo Alto, California, 94304, 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

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

  • Sood BG, Keszler M, Garg M, Klein JM, Ohls R, Ambalavanan N, Cotten CM, Malian M, Sanchez PJ, Lakshminrusimha S, Nelin LD, Van Meurs KP, Bara R, Saha S, Das A, Wallace D, Higgins RD, Shankaran S; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials. Trials. 2014 Dec 12;15:486. doi: 10.1186/1745-6215-15-486.

    PMID: 25496504DERIVED

Related Links

MeSH Terms

Conditions

Respiratory InsufficiencyHypertension, PulmonaryRespiratory Distress Syndrome, NewbornStreptococcal InfectionsPersistent Fetal Circulation SyndromeMeconium Aspiration Syndrome

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesLung DiseasesHypertensionVascular DiseasesCardiovascular DiseasesRespiratory Distress SyndromeInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLung InjuryFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, MonounsaturatedAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • 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

  • 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

    PRINCIPAL INVESTIGATOR

  • Kristi L. Watterberg, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

  • Roger G. Faix, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

  • Seetha Shankaran, MD

    Wayne State University

    PRINCIPAL INVESTIGATOR

  • Pablo J. Sanchez, MD

    University of Texas, Southwestern Medical Center at Dallas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 21, 2008

Study Start

May 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

March 22, 2019

Record last verified: 2015-07

Locations

US(11)