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Non-steroidal Anti-inflammatory Drug

Group 1 infants for Patent Ductus Arteriosus

Phase 4

Recruiting

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Preterm infants less than (< )29 weeks gestation at birth

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up (<1 ml/kg/hour for > 12 hours)

Awards & highlights

Study Summary

This trial is looking at babies who are born very prematurely and often have murmurs in their heart. One common cause of this murmur is the presence of a connection between major blood vessels that should close

Who is the study for?

This trial is for preterm infants born before 29 weeks of gestation who have a heart condition called hsPDA, detected by echocardiogram between 7-21 days old and need treatment as decided by their doctor.Check my eligibility

What is being tested?

The study tests two doses of Ibuprofen (standard and high) to treat hsPDA in premature babies. It also uses a device called NIRS to monitor how the drug affects oxygen supply to the brain, kidneys, and abdomen.See study design

What are the potential side effects?

Ibuprofen may cause side effects like kidney problems, bleeding issues, or digestive tract irritation. In preterm babies, there's also a risk it might affect blood flow patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was born before reaching 29 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ (<1 ml/kg/hour for > 12 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~(<1 ml/kg/hour for > 12 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and (<1 ml/kg/hour for > 12 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in regional tissue oxygenation (splanchnic, cerebral, and the splanchnic-cerebral oxygenation ratio 'SCOR') during hsPDA treatment

Change in splanchnic, cerebral, and renal Doppler blood flow during hsPDA treatment [Peak Systolic Velocity (PSV), End Diastolic Velocity (EDV), and Resistive Index (RI)]

Secondary outcome measures

Feeding intolerance

Gastrointestinal bleeding

Incidence of oliguria

+4 more

Trial Design

2Treatment groups

Active Control

Group I: Group 1 infantsActive Control1 Intervention

(n=15) will receive three doses of standard-dose Ibuprofen. (10-5-5 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses

Group II: Group 2 infantsActive Control1 Intervention

(n = 15) will receive three doses of high-dose Ibuprofen Motrin. (20-10-10 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,464 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently eligible to participate in this ongoing research study?

"Indeed, as stated on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible candidates. The trial was originally posted on June 1st, 2022 and the most recent update occurred on December 13th, 2023. Enrollment for this study aims to include a total of 30 participants across one site."

Answered by AI

What is the level of safety associated with Group 1 neonates for patients?

"Since Group 1 infants are part of a Phase 4 trial, indicating that the treatment has already been approved, our team at Power rates their safety level as 3."

Answered by AI

What is the current number of individuals participating in this clinical investigation?

"Indeed, as outlined on clinicaltrials.gov, this study is actively seeking eligible participants. The trial was initially posted on June 1st, 2022 and underwent its most recent update on December 13th, 2023. A total of 30 individuals will be enrolled in the trial across a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.

2022. "PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05325177.