Management of the PDA Trial (PDA)
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| ClinicalTrials.gov Identifier: NCT03456336 |
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Recruitment Status :
Recruiting
First Posted : March 7, 2018
Last Update Posted : March 22, 2023
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Sponsor:
NICHD Neonatal Research Network
Information provided by (Responsible Party):
NICHD Neonatal Research Network
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Brief Summary:
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Premature Patent Ductus Arteriosus Infant, Newborn, Diseases Patent Ductus Arteriosus After Premature Birth | Other: Active Treatment Other: Expectant Management | Phase 3 |
This is a pragmatic randomized multicenter, effectiveness study comparing active treatment of a symptomatic patent ductus arteriosus (sPDA) to expectant management. We hypothesize in premature infants with a sPDA, expectant management reduces the incidence proportion of death or BPD by 10% (from 50% to 40%) when compared to active treatment.
Participants with a sPDA allocated to the active treatment arm will receive intravenous administration of indomethacin or ibuprofen (depending on center preference). The decision to ligate will be left to the clinical team. Participants with a sPDA allocated to the expectant management arm will receive supportive care at the clinical team's discretion and will receive indomethacin/ibuprofen or ligation if the infant develops cardiopulmonary compromise. The decision to ligate will be left to the clinical team.
The primary endpoint for the study will be death or BPD (as assessed by the physiologic definition) at 36 weeks postmenstrual age (PMA).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1116 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Management of the Patent Ductus Arteriosus in Premature Infants Trial (PDA Trial) |
| Actual Study Start Date : | December 3, 2018 |
| Estimated Primary Completion Date : | March 2027 |
| Estimated Study Completion Date : | March 2029 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Active Treatment Group
Infants assigned to the active treatment group will receive indomethacin or ibuprofen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other.
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Other: Active Treatment
Infants assigned to the active treatment group will receive indomethacin or ibuprofen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other. If the infant receives both, it will be considered a protocol violation. |
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Active Comparator: Expectant Management Group
Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.
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Other: Expectant Management
Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs. |
Primary Outcome Measures :
- Death or Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA [ Time Frame: birth to 36 week postmenstrual age ]Death or BPD. BPD will be defined by the physiologic definition.
Secondary Outcome Measures :
- Mortality at 36 weeks PMA [ Time Frame: birth to 36 week postmenstrual age ]mortality assessed at 36 week postmenstrual age
- Mortality before discharge [ Time Frame: birth to 120 days of life ]mortality assessed prior to hospital discharge
- Bronchopulmonary dysplasia - Physiological Test [ Time Frame: birth to 36 week postmenstrual age ]BPD defined by the physiologic test of oxygen therapy
- Bronchopulmonary dysplasia - NIH Consensus Definition [ Time Frame: birth to 36 week postmenstrual age ]BPD defined by the NIH consensus definition of moderate or severe
- Necrotizing Enterocolitis (NEC) at 36 weeks PMA [ Time Frame: birth to 36 weeks post menstrual age ]Proven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB
- Retinopathy of Prematurity at 36 weeks PMA [ Time Frame: birth to 36 weeks post menstrual age ]Stage 3 or worse in either eye AND as any intervention therapy-retinal ablation, scleral buckle/vitrectomy, avastin or other anti-VEGF drug
- Receipt of therapies designed to close the PDA [ Time Frame: birth to 120 days ]Defined as ligation or cardiac catheterization
- Weight at 36 weeks PMA [ Time Frame: birth to 36 weeks post menstrual age ]Weight assessed at 36 weeks post menstrual age
- Height at 36 weeks PMA [ Time Frame: birth to 36 weeks post menstrual age ]Height assessed at 36 weeks post menstrual age
- Head Circumference at 36 weeks PMA [ Time Frame: birth to 36 weeks post menstrual age ]Head Circumference assessed at 36 weeks post menstrual age
Other Outcome Measures:
- Necrotizing Enterocolitis (NEC) at status (2 years) [ Time Frame: 26 months corrected age ]Proven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB
- Retinopathy of Prematurity at status (2 years) [ Time Frame: 26 months corrected age ]Stage 3 or worse in either eye AND as any intervention therapy-retinal ablation, scleral buckle/vitrectomy, avastin or other anti-VEGF drug
- Weight at status (2 years) [ Time Frame: 26 months corrected age ]Weight assessed at status (2 years)
- Height at status (2 years) [ Time Frame: 26 months corrected age ]Height assessed at status (2 years)
- Head Circumference at status (2 years) [ Time Frame: 26 months corrected age ]Head Circumference assessed at status (2 years)
- Neurodevelopmental impairment (NDI) at status (2 years) [ Time Frame: 26 months corrected age ]Severe NDI will be defined by any of the following: a BSID III cognitive score < 70, Gross Motor Functional (GMF) Level of 3-5, blindness (<20/200 vision) or profound hearing loss (inability to understand commands despite amplification); moderate NDI will be defined as a BSID III cognitive score 70-84 and either a GMF level of 2 or a hearing deficit requiring amplification to understand commands or unilateral blindness; mild NDI will be defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMF level 1 or hearing loss not requiring amplification. Normal (no NDI) will be defined by a cognitive score ≥ 85 and absence of any neurosensory deficits.
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| Ages Eligible for Study: | 48 Hours to 21 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Postnatal age 48 hours -21 days
- Infant 22 0/7 to 28 6/7 weeks gestation at birth
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sPDA, as defined as:
- Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on echocardiogram
- Mild or Moderate Clinical Criteria with Large PDA on echocardiogram
Exclusion Criteria:
- Cardiopulmonary compromise
- Known congenital heart disease (besides atrial septal defect or ventricular septal defect)
- Known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonary adenomatous malformation)
- Any condition which, in the opinion of the investigator, would preclude enrollment
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456336
Contacts
| Contact: Matthew Laughon, MD, MPH | 984-974-5063 | matt_laughon@med.unc.edu | |
| Contact: Abhik Das, PhD | 301-230-4640 |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Waldemar A. Carlo, MD 205-934-4680 | |
| Principal Investigator: Waldemar A. Carlo, MD | |
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Krisa P. Van Meurs, MD 650-723-5711 | |
| Principal Investigator: Krisa P. Van Meurs, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: David P Carlton, MD | |
| Principal Investigator: David P Carlton, MD | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Edward F. Bell, MD 319-356-4006 | |
| Principal Investigator: Edward F. Bell, MD | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Kristi L. Watterberg, MD | |
| Principal Investigator: Kristi L. Watterberg, MD | |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Carl T D'Angio, MD | |
| Principal Investigator: Carl T D'Angio, MD | |
| United States, North Carolina | |
| RTI International | Active, not recruiting |
| Durham, North Carolina, United States, 27705 | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: C. Michael Cotten, MD | |
| Sub-Investigator: C. Michael Cotten, MD MHS | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Brenda Poindexter, MD 513-636-0252 | |
| Principal Investigator: Brenda Poindexter, MD | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Michele C. Walsh, MD MS 216-844-3387 | |
| Principal Investigator: Michele C. Walsh, MD MS | |
| Research Institute at Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Pablo Sanchez, MD | |
| Principal Investigator: Pablo Sanchez, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Eric Eichenwald, MD | |
| Principal Investigator: Eric Eichenwald, MD | |
| United States, Rhode Island | |
| Brown University - Women and Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Abbot R. Laptook, MD | |
| Principal Investigator: Abbot R Laptook, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Myra Myckoff, MD | |
| Principal Investigator: Myra Wyckoff, MD | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jon E Tyson, MD MPH | |
| Principal Investigator: Jon E. Tyson, MD MPH | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84108 | |
| Contact: Bradley Yoder, MD 801-581-7052 | |
| Principal Investigator: Bradley A. Yoder, MD | |
Sponsors and Collaborators
NICHD Neonatal Research Network
Additional Information:
| Responsible Party: | NICHD Neonatal Research Network |
| ClinicalTrials.gov Identifier: | NCT03456336 |
| Other Study ID Numbers: |
NICHD-NRN-0059 |
| First Posted: | March 7, 2018 Key Record Dates |
| Last Update Posted: | March 22, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Per NIH Data Sharing Plan |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Premature Birth Ductus Arteriosus, Patent Infant, Newborn, Diseases Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities |