Recruiting

Ibuprofen with NIRS

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05325177

Conditions

Patent Ductus Arteriosus After Premature Birth

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Standard Dose Ibuprofen

High Dose Ibuprofen

Study Details

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.

Conditions

Patent Ductus Arteriosus After Premature Birth

Study ID

NCT05325177

Start date

Jun 1, 2022

Status verified date

Jan, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.).

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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

active comparator: 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

Interventions

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

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Nadya Ben Fadel, MD

613-737-7600nbenfadel@cheo.on.ca

Locations

The Ottawa General Hospital

Recruiting

Ottawa, Canada

Contacts

Rebecca Grimwood

RGrimwood@cheo.on.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jan 30, 2024

Last verified

Jan, 2024

Keywords

  • Ibuprofen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2024-01-30.