Clinical trial NCT05493540: Oral Ibuprofen Versus Placebo in Treatment of Patent Ductus Arteriosus (PDA)in Preterm Infants
Official title: Oral Ibuprofen Versus Placebo in Management of Patent Ductus Arteriosus in Preterm Infants: A Double Blind, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patent Ductus Arteriosus After Premature Birth
Patent Ductus Arteriosus Conservative Management
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The management options of Patent Ductus Arteriosus are still controversial and differ between centers. Recently, conservative management has been gaining interest as the evidence of benefit from medical treatment in terms of mortality and morbidity is lacking.

This study will compare oral ibuprofen (the standard treatment) with the conservative treatment, in terms of ductal closure and morbidity and mortality at discharge in preterm neonates less than 34 weeks.

Detailed description: A double-blinded, randomized, placebo-control non-inferiority trial was conducted in the neonatal intensive care unit (NICU) of Ain Shams University children's hospital, Cairo, Egypt.

Informed consent was taken from the parents or legal guardians before enrolment, after fully explaining to them the nature of the study. The approval of the Research Ethics Committee at Ain Shams University was also obtained.

All preterm neonates less than 34 weeks were assessed in the first 48 hours by clinical and echocardiographic examination by a cardiologist to detect PDA and exclude any congenital heart disease.

All neonates meeting the inclusion criteria will be randomized into one of two groups:

Medical treatment group and Placebo group. Targeted neonatal Echo was repeated after 5 days of the start of medical treatment by a neonatologist or a cardiologist to assess PDA closure.

After 7 days of intervention, open-label is offered to all patients with the option of another course for patients in the medical treatment group and Rescue therapy in the Placebo group.

The short-term morbidity is documented.

Withdrawal and replacement of individual subjects:

* The attending physician can decide to withdraw a subject from the study for urgent medical reasons. If they wish, parents or caregivers can leave the study at any time for any reason.
* Infants who are withdrawn from the study will be managed according to NICU Protocols.

Eligibility criteria: Inclusion Criteria:

* Gestational age ≤ 34 weeks
* PDA Size \> 1.5 mm and predominantly left-to-right shunt
* One of the following:
* Signs of Pulmonary overflow: Left atrium/Aortic diameter ratio (LA/Ao), Left Ventricular End Diastolic Diameter (LVEDD).
* Signs of Systemic Hypo perfusion: Absent or Reversed diastolic flow in the aorta, celiac/mesenteric, or Anterior Cerebral Artery (ACA)/ Middle Cerebral Artery (MCA)

Exclusion Criteria:

* Chromosomal anomaly
* Congenital heart defect, other than PDA and/or patent foramen ovale
* Congenital or acquired gastrointestinal anomaly
* Previous episodes of Necrotizing enterocolitis (NEC) or intestinal perforation
* Active bleeding, especially intracranial or gastrointestinal hemorrhage
* Contraindications to the use of ibuprofen

Primary outcomes:
measure: Incidence of PDA Closure by Echocardiography
timeFrame: Hospital discharge (approximately 3 months unless death occurs first)
Secondary outcomes:
measure: Incidence of death during hospitalization
timeFrame: Hospital discharge (approximately 3 months unless death occurs first)
measure: Incidence of Necrotizing Enterocolitis (NEC)
timeFrame: Hospital discharge (approximately 3 months unless death occurs first)
measure: Incidence of Bronchopulmonary dysplasia (BPD)
timeFrame: Hospital discharge (approximately 3 months unless death occurs first)
measure: Incidence of Sepsis
timeFrame: Hospital discharge (approximately 3 months unless death occurs first)
measure: Incidence of Intraventricular hemorrhage (IVH)
timeFrame: Hospital discharge (approximately 3 months unless death occurs first)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Nada H Youssef
role: PRINCIPAL_INVESTIGATOR
References: