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Paracetamol Treatment of the Borderline Significant PDA

Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02819414
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
31
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

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 Names:
  • Novimol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Days to 6 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shaare Zedek Medical Center Jerusalem Israel 91031

    Sponsors and Collaborators

    • Shaare Zedek Medical Center

    Investigators

    • Principal Investigator: Cathy Hammerman, MD, Shaare Zedek Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cathy Hammerman, Director Div. Newborn Nurseries, Shaare Zedek Medical Center
    ClinicalTrials.gov Identifier:
    NCT02819414
    Other Study ID Numbers:
    • 0174-16-SZMC
    First Posted:
    Jun 30, 2016
    Last Update Posted:
    Jul 6, 2016
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Ductus Arteriosus, Patent
    Acetaminophen

    Study Results

    No Results Posted as of Jul 6, 2016