PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-12-31

Brief Summary

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Babies who are born very prematurely are often born with murmurs in the heart. In preterm babies, one of the most common causes of murmur is the presence of a PDA. This is the persistence of a connection that normally exists in the baby before it is born, connecting between the major blood vessels that leave the heart. In term babies, this channel closes shortly after birth when normal adult circulation is achieved. However, in preterm babies, the PDA can remain open, which can lead to multiple problems in the baby.

Our current standard of treatment in the Neonatal Intensive Care Unit (NICU) is to perform cardiac ultrasound (echocardiogram) in all babies less than 29 weeks gestation to diagnose the presence of hsPDA. We also use an echocardiogram to follow the PDA until complete closure. If present, the standard treatment in the NICU is to give medication, usually Ibuprofen, a non-steroidal anti-inflammatory drugs (NSAID), to close the PDA.

Near-infrared spectroscopy (NIRS) is a new type of device to detect oxygenated blood supply to the brain, kidney, and abdominal regions. This device is used to assess the effects of Ibuprofen on oxygen supply to these three regions.

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Detailed Description

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Conditions

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Patent Ductus Arteriosus After Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

The investigators are equipped with unique and complementary expertise that will propel this promising work forward. We will recruit 30 preterm infants less than (\<)29 weeks gestation at birth with echocardiographic evidence of hsPDA that require pharmacologic treatment. We will examine renal, cerebral, intestinal blood flow and tissue oxygenation in high-risk preterm infants receiving high dose or standard-dose Ibuprofen treatment for hsPDA. Successful completion of this study will establish feasibility and provide proof-of-concept for a future multi-center trial. We will use descriptive statistics to compare patients' characteristics. To compare NIRS and Doppler data between the two groups, we will use paired t-test if data is normally distributed or Wilcoxon signed-rank test if not normally distributed

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1 infants

(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 Type ACTIVE_COMPARATOR

Standard Dose Ibuprofen

Intervention Type DRUG

(10-5-5 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses

Group 2 infants

(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

Group Type ACTIVE_COMPARATOR

High Dose Ibuprofen

Intervention Type DRUG

(20-10-10 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses

Interventions

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Standard Dose Ibuprofen

(10-5-5 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses

Intervention Type DRUG

High Dose Ibuprofen

(20-10-10 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Preterm infants less than (\< )29 weeks gestation at birth
* Echocardiographic evidence of hsPDA (as outlined in the NICU PDA treatment guidelines) at 7-21 days of life requiring pharmacologic treatment as determined by the managing physician.

Exclusion Criteria

* Not able to consent for any reason
* Preterm infants with congenital heart disease except for PDA, PFO (patent foramen ovale), small and restrictive ASD (atrial septal defect), or small VSD (ventricular septal defect).
* Preterm infants with lethal genetic malformations.
* Preterm infants with congenital abdominal wall defects (omphalocele, gastroschisis).
* Preterm infants with congenital or acquired brain anomaly.
* Infants who receive ibuprofen for PDA treatment during the first week of life will be excluded. We will recruit infants between day 7 and 21 only because high-dose ibuprofen is not indicated during the first week of life
* Preterm infants with contraindications to Ibuprofen therapy, including severe intraventricular hemorrhage (IVH), low platelet count \< 50,000 platelets per microliter, renal impairment with creatinine \>160 mmol/L or necrotizing enterocolitis (NEC) \> Stage 2 (using modified bell's Criteria).
* Preterm infants with spontaneous intestinal perforation (SIP).
* Acute kidney injury (defined as an increase in serum creatinine of 50% or more from the previous lowest value or a urinary output of less than 1 mL/kg per hr.).

Maximum Eligible Age

29 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No