NCT02819414

Paracetamol Treatment of the Borderline Significant PDA

TIME TO RE-EVALUATE THE KINDER GENTLER APPROACH TO PATENT DUCTUS ARTERIOSUS (PDA) IN THE PRETERM NEONATE

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 3 Days – 6 Days
• Healthy volunteers: Not accepted

Summary

The therapeutic approach to the patent ductus arteriosus (PDA) in the premature neonate remains controversial. Currently it is generally accepted to treat only hemodynamically significant PDAs. The current investigation aims to study the effect of treatment on PDAs of borderline significance via a prospective, randomized controlled trial of paracetamol in this group.

Detailed description

In the neonatal intensive care unit of the Shaare Zedek Medical Center, preterm babies \<30 wks. GA, are studied echocardiographically on day of life 3-4. Pending parental informed consent, those diagnosed with a PDA of borderline significance will be randomized to receive either paracetamol or placebo for three days, followed by a repeat echocardiogram. If the PDA remains of borderline significance, the treatment will be continued for an additional 4 days (1 week total). Paracetamol levels and liver functions will be assessed after the third day. Babies will be followed until discharge for subsequent PDA pathology; respiratory distress and chronic lung disease \[CLD\]; necrotizing enterocolitis \[NEC\]; retinopathy of prematurity \[ROP\]. The investigators' primary goal is to demonstrate a decrease in the composite outcome of death or severe morbidity chronic lung disease \[CLD\], as shown by decreased time on supplemental oxygen and assisted ventilation. Secondary goals: * To demonstrate a decrease in subsequently diagnosed hs PDA, including * Decrease in the need for subsequent therapy for PDA closure * Decrease in surgical PDA ligations * To demonstrate a decrease in necrotizing enterocolitis (NEC) and/or ROP with treatment. * To demonstrate no adverse effect on blood flow in anterior cerebral, superior mesenteric and renal arteries.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	Paracetamol drops	15 mg/kg/dose x 4/day diluted 1:15 yielding dose of 2.25 ml/kg/dose to be given for three days
OTHER	Placebo	2.25 ml/kg/dose x 4/day of sterile water to be given for three days

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-06-01
• Completion: 2019-01-01
• First posted: 2016-06-30
• Last updated: 2016-07-06

Locations

1 site across 1 country: Israel