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Trial record 11 of 429 for:    shaare zedek

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
Sponsor:
Information provided by (Responsible Party):
Cathy Hammerman, 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.

Condition or disease Intervention/treatment Phase
Patent Ductus Arteriosus Drug: Paracetamol drops Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Placebo
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)



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Ages Eligible for Study:   up to 6 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center

Publications of Results:
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Responsible Party: Cathy Hammerman, Director Div. Newborn Nurseries, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02819414     History of Changes
Other Study ID Numbers: 0174-16-SZMC
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics