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TIME TO RE-EVALUATE THE KINDER GENTLER APPROACH TO PATENT DUCTUS ARTERIOSUS (PDA) IN THE PRETERM NEONATE
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.
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Shaare Zedek Medical Center
Jerusalem, Israel
Start Date
June 1, 2016
Primary Completion Date
June 1, 2018
Completion Date
January 1, 2019
Last Updated
July 6, 2016
80
ESTIMATED participants
Paracetamol drops
DRUG
Placebo
OTHER
Lead Sponsor
Shaare Zedek Medical Center
NCT06658496
NCT06298344
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06601114