Oral Ibuprofen Versus Placebo in Treatment of Patent Ductus Arteriosus (PDA)in Preterm Infants

Nada Youssef

Status and phase: Completed; Phase 2

Conditions: Patent Ductus Arteriosus After Premature Birth; Patent Ductus Arteriosus Conservative Management

Treatments: Drug: Placebo; Drug: Ibuprofen oral suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT05493540

MD 96 2020

Details and patient eligibility

About

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.

Full 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• Infants who are withdrawn from the study will be managed according to NICU Protocols.

Enrollment: 80 patients

Sex: All

Ages: 1 hour to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Medical treatment Group

Active Comparator group

Description:

40 preterm neonates will receive Ibuprofen oral suspension

Treatment:

Drug: Ibuprofen oral suspension

Placebo Group

Placebo Comparator group

Description:

40 preterm neonates will receive oral placebo

Treatment:

Drug: Placebo