Ibuprofen for Patent Ductus Arteriosus After Premature Birth

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA
Patent Ductus Arteriosus After Premature Birth+2 More
Ibuprofen - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a strategy of early treatment of a PDA in preterm infants is better than no treatment at all.

See full description

Eligible Conditions

  • Patent Ductus Arteriosus After Premature Birth

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Ibuprofen will improve 2 primary outcomes and 22 secondary outcomes in patients with Patent Ductus Arteriosus After Premature Birth. Measurement will happen over the course of 7 days postnatal age.

7 days postnatal age
Oliguria
Proportion of eligible infants recruited during the study period
Proportion of infants in control group meeting pre-defined safety criteria
Proportion of randomized infants with no reported protocol deviations
Pulmonary hemorrhage
Reasons for non-adherence to protocol
Reasons for non-recruitment
Receipt of open-label rescue medical treatment in the control group
Week 36
Chronic lung disease
Week 20
All-cause mortality during hospital stay
Completeness of data collection for clinical outcomes
Definite sepsis
Duration of hospitalization (days)
Duration of invasive mechanical ventilation
Gastrointestinal perforation
Intraventricular hemorrhage
Necrotizing enterocolitis
Periventricular leukomalacia
Postnatal corticosteroid use
Receipt of any PDA pharmacotherapy
Severe intraventricular hemorrhage
Severe retinopathy of prematurity
Surgical/interventional PDA closure
within seven days of the first dose of pharmacotherapy
Gastrointestinal bleeding

Trial Safety

Trial Design

2 Treatment Groups

Early conservative management strategy
1 of 2
Selective early medical treatment (SMART) strategy
1 of 2
Active Control
Experimental Treatment

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ibuprofen is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Selective early medical treatment (SMART) strategy
Drug
Infants who are randomized to experimental group will follow the SMART treatment protocol, which includes echocardiographic screening every 72 hours to categorize PDA disease severity by combining clinical and echocardiographic features. At any evaluation if patients are found to have a "severe PDA" on echocardiography, irrespective of clinical symptoms, or a "moderate PDA" on echocardiography with at least moderate clinical illness, they will receive pharmacotherapy aimed at PDA closure (The PDA severity has been divided into mild, moderate or severe based on pre-defined clinical and echocardiographic criteria).
Early conservative management strategyInfants randomized to this arm will not undergo any further echocardiographic assessment or pharmacological treatment of the PDA regardless of the clinical signs. If the infant gets an echocardiographic assessment for a reason different than PDA assessment (such as hypotension or oxygenation failure) and a PDA is incidentally noted that fits the treatment criteria, the infant will not be initiated on pharmacotherapy. After 7 days of age, decision on PDA assessment and treatment will be at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through hospital discharge (approximately 20 weeks postnatal age unless death occurs first) for reporting.

Who is running the study

Principal Investigator
D. S. M.
Prof. Dr. Souvik Mitrac, MD
IWK Health Centre

Closest Location

Sharp Mary Birch Hospital for Women & Newborns - San Diego, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Preterm infants less than 26 completed weeks (i.e., up to and including 25 weeks and 6 days) of gestation

Patient Q&A Section

What is ductus arteriosus, patent?

"PDA is a normal structure that is present at birth and it resolves spontaneously. However, there are clinical features that suggest a possible clinical problem. PDA, patent does not affect development of cardiovascular or pulmonary abnormalities. PDA, patent is not associated with other cardiovascular abnormalities like aortic coarctions. There are other causes for PDA, patent, and the treatment of PDA, patent is a clinical decision." - Anonymous Online Contributor

Unverified Answer

Can ductus arteriosus, patent be cured?

"DAP is rarely seen at the present time, but our experience shows that it can be cured once detected. The patients should have complete cardiological investigation with 2DTO by CT or MRI for confirmation. Early correction of DAP, avoiding complications of systemic right ventricular overloading, is essential for their long term survival." - Anonymous Online Contributor

Unverified Answer

What are the signs of ductus arteriosus, patent?

"Signs of ductus arteriosus, patent include cyanosis and hepatomegaly. Ductus arteriosus, patent causes decreased blood volume for the body to deliver to the rest of the body. This will cause cyanosis and swelling. Ductus arteriosus, patent must have some cause and may result when there is a tear or abnormality of the duct. The most likely causes of ductus arteriosus, patent are a congenital defect that may result in either absent or insufficient blood flow to the body from the aorta through the ductus, or may be secondary to trauma to the aorta or ductus. Patients may have decreased oxygen levels to the rest of the body due to decreased blood supply." - Anonymous Online Contributor

Unverified Answer

How many people get ductus arteriosus, patent a year in the United States?

"Approximately 60 infants per year require surgery to treat a patent ductus arteriosus in the United States. In the study population, 25% had only one open arterial switch, 37% had one peritoneal shunt, and 42% had a double balloon valve." - Anonymous Online Contributor

Unverified Answer

What causes ductus arteriosus, patent?

"DAP is diagnosed by echocardiogram and/or saturation test when the PA is more than 50%. PAO and LVM are important as predicting factors of DAP." - Anonymous Online Contributor

Unverified Answer

What are common treatments for ductus arteriosus, patent?

"For a patent pulmonary artery, echocardiogram, Doppler catheterization, and angiography are appropriate initial assessments. Followup with repeated echocardiograms is not necessary unless the diagnosis is questionable. As for patent ductus arteriosus, a patent ductus arteriosus is best managed by observation with regular echocardiographic and Doppler studies because no treatment is required for most children. For a patent ductus arteriosus with aorta to pulmonary arteries ratio less than or equal to 0.5:1 at 0-6 weeks of life, surgery should be deferred, with most cases undergoing expectant management." - Anonymous Online Contributor

Unverified Answer

Is ibuprofen safe for people?

"Infants with a patent ductus arteriosus who receive ibuprofen for at least 14 days are most likely to benefit; less safety is seen with longer dosing and in younger children, and may result in harm. The study results support the safety of prescribing ibuprofen to infants with a patent ductus arteriosus." - Anonymous Online Contributor

Unverified Answer

Does ibuprofen improve quality of life for those with ductus arteriosus, patent?

"Ibuprofen may reduce pain and fever in newborns with ductus arteriosus, but it does not improve quality of life, as measured by the Neonatal Outcome Questionnaire." - Anonymous Online Contributor

Unverified Answer

How serious can ductus arteriosus, patent be?

"When used empirically after an ECG is positive for SGA, ductus arteriosus, patent < 4 mm diameter is relatively harmless. Patients with ductus arteriosus, patent 4-5 mm should undergo immediate surgery. This treatment plan is supported by earlier studies demonstrating that ductus arteriosus, patent ≥ 4 mm is one of two best predictors of neonatal death." - Anonymous Online Contributor

Unverified Answer

Does ductus arteriosus, patent run in families?

"In a family with a high prevalence of ductus arteriosus, patentrun, patients with ductus patentrun and other associated cardiovascular defects have a higher frequency of cardiac malformations such as atrial septal defects, pulmonary valve stenosis, and patent foramen ovale." - Anonymous Online Contributor

Unverified Answer

Is ibuprofen typically used in combination with any other treatments?

"In the absence of clear evidence of benefit, ibuprofen is rarely used in routine practice for the treatment of patent ductus arteriosus. However, it is frequently used where patent ductus arteriosus exists as a part of the multimodal management of infants with neonatal respiratory distress and/or low blood oxygen levels." - Anonymous Online Contributor

Unverified Answer

What is ibuprofen?

"Ibuprofen has a major effect on fetal brain blood flow but has far less effect than aspirin is used in early human pregnancy. Ibuprofen can cause hypoxia at the brain-stem level, although these effects are mild; they would not, as far as knows, be expected to cause neural tube defects. However, ibuprofen treatment in the rat results in increased fetal mortality at a dose of 500 mg per g of bodyweight per day. This dose would not be expected to be used in a human fetus; ibuprofen exposure of pregnant women up to 1." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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