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Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure

Information source: NICHD Neonatal Research Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infant, Newborn; Respiratory Insufficiency; Pulmonary Hypertension; Respiratory Distress Syndrome, Newborn; Streptococcal Infections

Intervention: Inhaled Prostaglandin E1 (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: NICHD Neonatal Research Network

Official(s) and/or principal investigator(s):
Michele C. Walsh, MD MS, Principal Investigator, Affiliation: Case Western Reserve University, Rainbow Babies and Children's Hospital
Ronald N. Goldberg, MD, Principal Investigator, Affiliation: Duke University
Krisa P. Van Meurs, MD, Principal Investigator, Affiliation: Stanford University
Ivan D. Frantz III, MD, Principal Investigator, Affiliation: Tufts Medical Center
Waldemar A. Carlo, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham
Edward F. Bell, MD, Principal Investigator, Affiliation: University of Iowa
Kristi L. Watterberg, MD, Principal Investigator, Affiliation: University of New Mexico
Roger G. Faix, MD, Principal Investigator, Affiliation: University of Utah
Seetha Shankaran, MD, Principal Investigator, Affiliation: Wayne State University
Pablo J. Sanchez, MD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center at Dallas

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

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

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.

Eligibility

Minimum age: N/A. Maximum age: 7 Days. Gender(s): Both.

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

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States

Stanford University, Palo Alto, California 94304, United States

University of Iowa, Iowa City, Iowa 52242, United States

Tufts Medical Center, Boston, Massachusetts 02111, United States

Wayne State University, Detroit, Michigan 48201, United States

University of New Mexico, Albuquerque, New Mexico 87131, United States

Duke University, Durham, North Carolina 27710, United States

RTI International, Durham, North Carolina 27705, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235, United States

University of Utah, Salt Lake City, Utah 84108, United States

Additional Information

NICHD Neonatal Research Network

Starting date: May 2008
Last updated: July 27, 2015

Page last updated: August 23, 2015

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