This trial is active, not recruiting.

Condition patent ductus arteriosus
Treatments paracetamol drops, placebo
Phase phase 2
Sponsor Shaare Zedek Medical Center
Start date June 2016
End date June 2018
Trial size 80 participants
Trial identifier NCT02819414, 0174-16-SZMC


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
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.
2.25 ml/kg/dose x 4/day of sterile water to be given for three days
(Active Comparator)
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.
paracetamol drops Novimol
15 mg/kg/dose x 4/day diluted 1:15 yielding dose of 2.25 ml/kg/dose to be given for three days

Primary Outcomes

Composite outcome of death or severe morbidity chronic lung disease [CLD]
time frame: Day of life 3 until 40 weeks post-conception

Secondary Outcomes

Subsequently diagnosed hs PDA
time frame: Completion of study intervention until 40 weeks post-conception
Subsequent incidence of necrotizing enterocolitis (NEC) and/or retinopathy of prematurity (ROP)
time frame: Completion of study intervention until 40 weeks post-conception

Eligibility Criteria

Male or female participants up to 6 days old.

Inclusion Criteria: - Preterm neonates < 30 weeks' gestational age PDA of borderline significance Exclusion Criteria: - 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

Additional Information

Principal investigator Cathy Hammerman, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Shaare Zedek Medical Center.