A Phase 2 interventional study of Inhaled Prostaglandin E1 in Infant, Newborn, Respiratory Insufficiency and Pulmonary Hypertension, sponsored by NICHD Neonatal Research Network. Withdrawn at 11 sites in United States. Open to participants aged Up to 7 Days. Per ClinicalTrials.gov, last updated 2019-03-22.
Sponsored by NICHD Neonatal Research Network · Phase 2, Interventional, and Treatment
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.
155 studies on the registry are indexed under Streptococcal Infections; 15 are open to participants now.
Browse Streptococcal Infections studies →NICHD Neonatal Research Network is the lead sponsor of 63 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PGE1 300 ng/kg/min via nebulizer over a 72-hour period
Drug: Inhaled Prostaglandin E1
PGE1 150 ng/kg/min via nebulizer over a 72-hour period
Drug: Inhaled Prostaglandin E1
Normal saline, the diluent for the drug, via nebulizer over a 72-hour period
Drug: Inhaled Prostaglandin E1
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
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
Progression to an OI greater than 25
Time frame: 72-hours after enrollment
Improvement in partial pressure of oxygen (PaO2) in the blood gas
Time frame: 72-hours after enrollment
Change in OI
Time frame: 72 hours after enrollment
Death
Time frame: 72-hours after intervention
Need for inhaled nitric oxide or ECMO
Time frame: 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
This study is withdrawn, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NICHD Neonatal Research Network