Infant, NewbornPhase 2IPGE1NCT00598429
Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure
A Phase 2 study testing Inhaled Prostaglandin E1 in people with Infant, Newborn and Respiratory Insufficiency, run by NICHD Neonatal Research Network at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Infant, Newborn, Respiratory Insufficiency, Pulmonary Hypertension
- What is being tested?
- Inhaled Prostaglandin E1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2008to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Tufts Medical Center
Boston, Massachusetts, 02111
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
RTI International
Durham, North Carolina, 27705
Duke University
Durham, North Carolina, 27710
University of Iowa
Iowa City, Iowa, 52242
Stanford University
Palo Alto, California, 94304
University of Utah
Salt Lake City, Utah, 84108
About this study
Official title: 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.
Read the 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.
- Conditions
- Infant, Newborn, Respiratory Insufficiency, Pulmonary Hypertension, Respiratory Distress Syndrome, Newborn, Streptococcal Infections
- Being tested
- Inhaled Prostaglandin E1
- Keywords
- NICHD Neonatal Research Network, Hypoxemic respiratory failure (HRF), Persistent pulmonary hypertension of the newborn (PPHN), Prostaglandin E1 (PGE1), Mechanical ventilation, Meconium, aspiration
- Medical subject headings
- Respiratory Insufficiency, Hypertension, Pulmonary, Respiratory Distress Syndrome, Newborn, Streptococcal Infections, Persistent Fetal Circulation Syndrome, Meconium Aspiration Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Prostaglandin E1Drug
Also called Alprostadil
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
| Study group | Role | What they receive |
|---|---|---|
| High dose | Active comparator | PGE1 300 ng/kg/min via nebulizer over a 72-hour period Receives: Drug: Inhaled Prostaglandin E1 |
| Low dose | Active comparator | PGE1 150 ng/kg/min via nebulizer over a 72-hour period Receives: Drug: Inhaled Prostaglandin E1 |
| Placebo | Placebo comparator | Normal saline, the diluent for the drug, via nebulizer over a 72-hour period Receives: Drug: Inhaled Prostaglandin E1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to recruit an adequate number of patients (n = 50) in a 6-9 month period without excessive (>20%) protocol violations.
Measured: 6-9 months after trial begins recruitment
Secondary outcomes (9)
Progression to an OI greater than 25
Measured: 72-hours after enrollment
Improvement in partial pressure of oxygen (PaO2) in the blood gas
Measured: 72-hours after enrollment
Change in OI
Measured: 72 hours after enrollment
Death
Measured: 72-hours after intervention
Need for inhaled nitric oxide or ECMO
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Withdrawn due to lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Michele C. Walsh, MD MS, Principal investigator, Case Western Reserve University, Rainbow Babies and Children's HospitalRonald N. Goldberg, MD, Principal investigator, Duke UniversityKrisa P. Van Meurs, MD, Principal investigator, Stanford UniversityIvan D. Frantz III, MD, Principal investigator, Tufts Medical CenterWaldemar A. Carlo, MD, Principal investigator, University of Alabama at BirminghamEdward F. Bell, MD, Principal investigator, University of IowaKristi L. Watterberg, MD, Principal investigator, University of New MexicoRoger G. Faix, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598429
- Sponsor's protocol ID
- NICHD-NRN-0037
- Other IDs
- U10HD036790, U10HD021364, U10HD021385, U10HD027880, U10HD034216, U10HD040492, U10HD040689, U10HD053089
- Acronym
- IPGE1
- Status last verified
- Jul 2015
- First submitted
- 10 Jan 2008
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25496504
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Inhaled PGE1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure. A Protocol for the NICHD Neonatal Research Network
- ClinicalTrials.gov ID
- NCT00598429
- Acronym / sponsor ID
- IPGE1 / NICHD-NRN-0037
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose | Active comparator | Drug: Inhaled Prostaglandin E1PGE1 300 ng/kg/min via nebulizer over a 72-hour period |
| Low dose | Active comparator | Drug: Inhaled Prostaglandin E1PGE1 150 ng/kg/min via nebulizer over a 72-hour period |
| Placebo | Placebo comparator | Drug: Inhaled Prostaglandin E1Normal saline, the diluent for the drug, via nebulizer over a 72-hour period |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled Prostaglandin E1Also: AlprostadilDelivery 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 | Drug | High dose, Low dose, Placebo |
Primary outcome
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
9 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Derived from this study: PubMed 25496504Sood 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.
- NICHD Neonatal Research NetworkLink provided by the sponsor.
Related trials for Infant, Newborn
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele C. Walsh, MD MS principal investigator
Case Western Reserve University, Rainbow Babies and Children's Hospital
Ronald N. Goldberg, MD principal investigator
Duke University
Krisa P. Van Meurs, MD principal investigator
Stanford University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled Prostaglandin E1 in people with Infant, Newborn and Respiratory Insufficiency, run by NICHD Neonatal Research Network at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00598429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.