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Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure (IPGE1)

Primary Purpose

Infant, Newborn, Respiratory Insufficiency, Pulmonary Hypertension

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Inhaled Prostaglandin E1

About this trial

This is an interventional treatment trial for Infant, Newborn focused on measuring NICHD Neonatal Research Network, Hypoxemic respiratory failure (HRF), Persistent pulmonary hypertension of the newborn (PPHN), Prostaglandin E1 (PGE1), Mechanical ventilation, Meconium, aspiration

Eligibility Criteria

undefined - 7 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University of Alabama at Birmingham
Stanford University
University of Iowa
Tufts Medical Center
Wayne State University
University of New Mexico
RTI International
Duke University
Case Western Reserve University, Rainbow Babies and Children's Hospital
University of Texas Southwestern Medical Center at Dallas
University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

High dose

Low dose

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression to an OI greater than 25

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

Change in OI

Death

Need for inhaled nitric oxide or ECMO

Length of hospitalization

Duration of mechanical ventilation

Number of days of oxygen used and need for supplemental oxygen at 28 days of life

Occurrence of grade III-IV intracranial hemorrhage and cystic leukomalacia

Full Information

NCT ID

NCT00598429

First Posted

January 10, 2008

Last Updated

March 20, 2019

Sponsor

NICHD Neonatal Research Network

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT00598429

Brief Title

Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure

Acronym

IPGE1

Official Title

Randomized Clinical Trial of Inhaled PGE1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure. A Protocol for the NICHD Neonatal Research Network

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Withdrawn due to lack of recruitment

Study Start Date

May 2008 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NICHD Neonatal Research Network

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Hypoxemic respiratory failure (HRF), frequently associated with persistent pulmonary hypertension of the newborn (PPHN), is a rare, but life-threatening condition affecting approximately 2 to 9 percent of infants admitted to neonatal intensive care units and results in significant morbidity and mortality. It occurs more often in full- or post-term babies whose circulatory systems do not adapt well to breathing outside the womb. HRF may result from congenital hernia of the diaphragm, group B streptococcal infection, inhaling meconium in the womb, or respiratory distress syndrome. Medical treatments, such as high frequency ventilation, inhaled nitric oxide, and Extracorporeal Membrane Oxygenation (ECMO, a heart and lung support machine), have significantly increased survival of children with HRF. These therapies, while successful, however, have a variety of side effects and potential long-term disabilities. This feasibility trial was designed to test the safety of using the intravenous form of Prostaglandin E1 in an inhaled form (iPGE1) on infants born at 34 0/7ths weeks gestational age or greater diagnosed with hypoxemic respiratory failure and on assisted ventilation. The intravenous form of PGE1 was to be aerosolized and administered via a nebulizer attached to the infant's ventilator. The goal was to enroll 50 subjects within 6-9 months, in preparation for a larger, multi-center randomized control trial; however, the study was withdrawn for lack of recruitment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant, Newborn, Respiratory Insufficiency, Pulmonary Hypertension, Respiratory Distress Syndrome, Newborn, Streptococcal Infections

Keywords

NICHD Neonatal Research Network, Hypoxemic respiratory failure (HRF), Persistent pulmonary hypertension of the newborn (PPHN), Prostaglandin E1 (PGE1), Mechanical ventilation, Meconium, aspiration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High dose

Arm Type

Active Comparator

Arm Description

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

Arm Title

Low dose

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Inhaled Prostaglandin E1

Other Intervention Name(s)

Alprostadil

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6-9 months after trial begins recruitment

Secondary Outcome Measure Information:

Title

Progression to an OI greater than 25

Time Frame

72-hours after enrollment

Title

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

Time Frame

72-hours after enrollment

Title

Change in OI

Time Frame

72 hours after enrollment

Title

Death

Time Frame

72-hours after intervention

Title

Need for inhaled nitric oxide or ECMO

Time Frame

72-hours after enrollment

Title

Length of hospitalization

Title

Duration of mechanical ventilation

Title

Number of days of oxygen used and need for supplemental oxygen at 28 days of life

Title

Occurrence of grade III-IV intracranial hemorrhage and cystic leukomalacia

10. Eligibility

Sex

All

Maximum Age & Unit of Time

7 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials: