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NCT Number: NCT05493540

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

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.

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Key information

Conditions

Patent Ductus Arteriosus After Premature Birth Patent Ductus Arteriosus Conservative Management

Age range

1 hour–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine Ain Shams University

Cairo, Egypt

About this study

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  • Infants who are withdrawn from the study will be managed according to NICU Protocols.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen oral suspension

Drug

The medical treatment group will receive oral Ibuprofen with conservative therapy in the form of fluid restriction, Positive End Expiratory Pressure (PEEP), and/or diuretics

An additional course of Ibuprofen may be offered if there is:

  • Moderate/Severe PDA on Echocardiography
  • Prolonged ventilation or Increased ventilatory setting
  • Prolonged use of inotropes or vasopressors or escalating dose
  • Another form of treatment may be offered if the patient developed side effects from Ibuprofen

Other names: Active treatment

Placebo

Drug

Placebo Group will receive Oral Placebo and Conservative therapy in the form of fluid restriction, PEEP, and/or diuretics

An Open-label option might be offered if there are concerns by attending physicians over the poor patient condition that might be attributed to persistent PDA:

  • Prolonged Ventilation or Escalating Ventilatory Setting
  • Prolonged Use Of Inotropes or Vasopressors or escalation of Doses

Rescue therapy in the form of a course of oral ibuprofen may be offered:

  • After 5 days of recruitment
  • Moderate/Severe PDA on Echocardiography
  • Prolonged ventilation or Increased ventilatory setting
  • Prolonged use of inotropes or vasopressors or escalating dose - Another form of treatment may be offered if the patient developed side effects from Ibuprofen

Other names: Conservative

Primary outcomes

  1. Incidence of PDA Closure by Echocardiography

    Time frame: Hospital discharge (approximately 3 months unless death occurs first)

    Compare the incidence of PDA closure assessed by Echocardiography during hospitalization between the two groups

Secondary outcomes

  1. Incidence of death during hospitalization

    Time frame: Hospital discharge (approximately 3 months unless death occurs first)

    Compare the incidence of death during hospitalization between the two groups

  2. Incidence of Necrotizing Enterocolitis (NEC)

    Time frame: Hospital discharge (approximately 3 months unless death occurs first)

    Compare the incidence of NEC during hospitalization between the two groups by Bell's staging

  3. Incidence of Bronchopulmonary dysplasia (BPD)

    Time frame: Hospital discharge (approximately 3 months unless death occurs first)

    Compare the Incidence of BPD (needing supplemental oxygen at 28 days of life) during hospitalization between the two groups

  4. Incidence of Sepsis

    Time frame: Hospital discharge (approximately 3 months unless death occurs first)

    Compare the Incidence of sepsis during hospitalization between the two groups by positive blood culture.

  5. Incidence of Intraventricular hemorrhage (IVH)

    Time frame: Hospital discharge (approximately 3 months unless death occurs first)

    Compare the Incidence of IVH during hospitalization between the two groups by transcranial ultrasound

Sponsors and collaborators

Lead sponsor

Nada Youssef

Other

Registry information

Official study title

Oral Ibuprofen Versus Placebo in Management of Patent Ductus Arteriosus in Preterm Infants: A Double Blind, Randomized Control Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2022
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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