Paracetamol Treatment of the Borderline Significant PDA
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|ClinicalTrials.gov Identifier: NCT02819414|
Recruitment Status : Unknown
Verified July 2016 by Cathy Hammerman, Shaare Zedek Medical Center.
Recruitment status was: Active, not recruiting
First Posted : June 30, 2016
Last Update Posted : July 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Patent Ductus Arteriosus||Drug: Paracetamol drops Other: Placebo||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||TIME TO RE-EVALUATE THE KINDER GENTLER APPROACH TO PATENT DUCTUS ARTERIOSUS (PDA) IN THE PRETERM NEONATE|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||January 2019|
Placebo Comparator: Control Group
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 Group
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.
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 Name: Novimol
- Composite outcome of death or severe morbidity chronic lung disease [CLD] [ Time Frame: Day of life 3 until 40 weeks post-conception ]Chronic lung disease will be assessed by time on supplemental oxygen and assisted ventilation.
- Subsequently diagnosed hs PDA [ Time Frame: 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) [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819414
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 91031|
|Principal Investigator:||Cathy Hammerman, MD||Shaare Zedek Medical Center|