PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.

Patent Ductus Arteriosus After Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325177
• Other study ID #: NICU-PDA-01
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Ottawa Hospital Research Institute
• Contact: Nadya Ben Fadel, MD
• Phone: 613-737-7600
• Email: nbenfadel[@]cheo.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 29 Weeks

Eligibility

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.).

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus After Premature Birth
• Premature Birth

Intervention

Drug:
• Standard Dose Ibuprofen
(10-5-5 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses
• High Dose Ibuprofen
(20-10-10 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses

Locations

Country	Name	City	State
Canada	The Ottawa General Hospital	Ottawa

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in regional tissue oxygenation (splanchnic, cerebral, and the splanchnic-cerebral oxygenation ratio 'SCOR') during hsPDA treatment		with the first 28 days after enrolment
Primary	Change in splanchnic, cerebral, and renal Doppler blood flow during hsPDA treatment [Peak Systolic Velocity (PSV), End Diastolic Velocity (EDV), and Resistive Index (RI)]		with the first 28 days after enrolment
Secondary	Necrotizing Enterocolitis (NEC): > 2 (Modified bell's Criteria)		with the first 28 days after enrolment
Secondary	Spontaneous intestinal perforation (SIP)		with the first 28 days after enrolment
Secondary	Incidence of oliguria		(<1 ml/kg/hour for > 12 hours)
Secondary	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	with the first 28 days after enrolment
Secondary	Gastrointestinal bleeding	Any amount of visible bright red or altered blood in emesis, nasogastric tube, or feces	with the first 28 days after enrolment
Secondary	Pulmonary hemorrhage		with the first 28 days after enrolment
Secondary	Presence of echocardiographic features of pulmonary hypertension		with the first 28 days after enrolment