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| ID | Type | Description | Link |
|---|---|---|---|
| U10HD036790 | U.S. NIH Grant/Contract | View source | |
| U10HD021364 | U.S. NIH Grant/Contract | View source | |
| U10HD021385 | U.S. NIH Grant/Contract | View source | |
| U10HD027880 | U.S. NIH Grant/Contract | View source | |
| U10HD034216 | U.S. NIH Grant/Contract | View source | |
| U10HD040492 | U.S. NIH Grant/Contract | View source | |
| U10HD040689 | U.S. NIH Grant/Contract | View source | |
| U10HD053089 | U.S. NIH Grant/Contract | View source | |
| U10HD053109 | U.S. NIH Grant/Contract | View source | |
| U10HD053119 | U.S. NIH Grant/Contract | View source | |
| U10HD053124 | U.S. NIH Grant/Contract | View source |
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Withdrawn due to lack of recruitment
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose | Active Comparator | PGE1 300 ng/kg/min via nebulizer over a 72-hour period |
|
| Low dose | Active Comparator | PGE1 150 ng/kg/min via nebulizer over a 72-hour period |
|
| Placebo | Placebo Comparator | Normal saline, the diluent for the drug, via nebulizer over a 72-hour period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Prostaglandin E1 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25496504 | Derived | 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. |
| Label | URL |
|---|---|
| NICHD Neonatal Research Network | View source |
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|
| Change in OI |
| 72 hours after enrollment |
| Death | 72-hours after intervention |
| Need for inhaled nitric oxide or ECMO | 72-hours after enrollment |
| 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 |
| University of Texas, Southwestern Medical Center at Dallas |
| Principal Investigator |
| 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 |
| RTI International | Durham | North Carolina | 27705 | United States |
| Duke University | Durham | North Carolina | 27710 | 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 |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D006976 | Hypertension, Pulmonary |
| D012127 | Respiratory Distress Syndrome, Newborn |
| D013290 | Streptococcal Infections |
| D010547 | Persistent Fetal Circulation Syndrome |
| D008471 | Meconium Aspiration Syndrome |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012128 | Respiratory Distress Syndrome |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D055370 | Lung Injury |
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000527 | Alprostadil |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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