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PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.

Primary Purpose

Patent Ductus Arteriosus After Premature Birth

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Standard Dose Ibuprofen

High Dose Ibuprofen

About this trial

This is an interventional treatment trial for Patent Ductus Arteriosus After Premature Birth focused on measuring Ibuprofen

Eligibility Criteria

undefined - 29 Weeks (Child)All SexesDoes not accept healthy volunteers

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:

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.
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.).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 1 infants

Group 2 infants

Arm Description

(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

(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

Outcomes

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

Necrotizing Enterocolitis (NEC): > 2 (Modified bell's Criteria)

Spontaneous intestinal perforation (SIP)

Incidence of oliguria

Feeding intolerance

we define feeding intolerance as the decision by the managing team to withhold feeds for at least 24 hours in the absence of definite evidence of medical or surgical NEC

Gastrointestinal bleeding

Any amount of visible bright red or altered blood in emesis, nasogastric tube, or feces

Pulmonary hemorrhage

Presence of echocardiographic features of pulmonary hypertension

Full Information

NCT ID

NCT05325177

First Posted

April 5, 2022

Last Updated

April 26, 2022

Sponsor

Ottawa Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05325177

Brief Title

PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.

Official Title

A Pilot, Randomized Controlled Study of the Effects of High Dose Ibuprofen on Cerebral and Splanchnic Tissue Oxygenation During Treatment of Hemodynamically Significant Patent Ductus Arteriosus (hsPDA) in Preterm Infants

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2022 (Anticipated)

Primary Completion Date

December 1, 2022 (Anticipated)

Study Completion Date

June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patent Ductus Arteriosus After Premature Birth

Keywords

Ibuprofen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 infants

Arm Type

Active Comparator

Arm Description

(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

Arm Title

Group 2 infants

Arm Type

Active Comparator

Arm Description

(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

Intervention Type

Drug

Intervention Name(s)

Standard Dose Ibuprofen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

High Dose Ibuprofen

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

with the first 28 days after enrolment

Title

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

Time Frame

with the first 28 days after enrolment

Secondary Outcome Measure Information:

Title

Necrotizing Enterocolitis (NEC): > 2 (Modified bell's Criteria)

Time Frame

with the first 28 days after enrolment

Title

Spontaneous intestinal perforation (SIP)

Time Frame

with the first 28 days after enrolment

Title

Incidence of oliguria

Time Frame

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

Title

Feeding intolerance

Description

we define feeding intolerance as the decision by the managing team to withhold feeds for at least 24 hours in the absence of definite evidence of medical or surgical NEC

Time Frame

with the first 28 days after enrolment

Title

Gastrointestinal bleeding

Description

Any amount of visible bright red or altered blood in emesis, nasogastric tube, or feces

Time Frame

with the first 28 days after enrolment

Title

Pulmonary hemorrhage

Time Frame

with the first 28 days after enrolment

Title

Presence of echocardiographic features of pulmonary hypertension

Time Frame

with the first 28 days after enrolment

10. Eligibility

Sex

All

Maximum Age & Unit of Time

29 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. 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.).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nadya Ben Fadel, MD

Phone

613-737-7600

Ext

3716

nbenfadel@cheo.on.ca

12. IPD Sharing Statement

Plan to Share IPD

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PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.

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