Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure
| Status: | Withdrawn |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Cardiology, Infectious Disease, Hospital, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/24/2019 |
| Start Date: | May 2008 |
| End Date: | September 2008 |
Randomized Clinical Trial of Inhaled PGE1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure. A Protocol for the NICHD Neonatal Research Network
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.
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.
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.
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.
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
We found this trial at
11
sites
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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University of Utah Research is a major component in the life of the U benefiting...
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University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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