Paracetamol Treatment of the Borderline Significant PDA
- Registration Number
- NCT02819414
- Lead Sponsor
- Shaare Zedek Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Preterm neonates < 30 weeks' gestational age PDA of borderline significance
- Infants not deemed likely to survive more than one week Infants with congenital heart malformations Infants with pulmonary hypertension and right to left ductal shunting
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Placebo Treatment with placebo at a volume of 2.25 cc/kg/dose x 4/day to be given with feeds, or in place of feed when baby is receiving \<2 cc/kg/feed. Treatment Group Paracetamol drops Treatment with paracetamol drops at 15 mg/kg/dose x 4/day. Drops will be diluted 1:15 in order to reduce osmolality. This will yield a dose of 2.25 ml/kg/dose, to be given with feeds, or in place of feed when baby is receiving \<2 cc/kg/feed.
- Primary Outcome Measures
Name Time Method Composite outcome of death or severe morbidity chronic lung disease [CLD] Day of life 3 until 40 weeks post-conception Chronic lung disease will be assessed by time on supplemental oxygen and assisted ventilation.
- Secondary Outcome Measures
Name Time Method Subsequently diagnosed hs PDA Completion of study intervention until 40 weeks post-conception Will be assessed by subsequent need for medical or surgical intervention for closure of PDA
Subsequent incidence of necrotizing enterocolitis (NEC) and/or retinopathy of prematurity (ROP) Completion of study intervention until 40 weeks post-conception Study infants will be followed clinically and any occurrence of NEC or ROP will be recorded with its level of significance (Bell staging for NEC and Stage of ROP)
Trial Locations
- Locations (1)
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel