Ductus Arteriosus, PatentPhase 2/3NCT03604796
Alternative Paracetamol Treatments for the Neonate With a hsPDA
A Phase 2/3 study testing Rectal Solution and Intravenous Infusion in people with Ductus Arteriosus, Patent, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Early targeted treatment of a hemodynamically significant patent ductus arteriosus (hsPDA) during the first week of life in preterm neonates is often recommended. Our standard first line therapeutic approach is enteral acetaminophen. Read more about this study
- Who is it for?
- Ages 2 to 10 days
- Conditions the study is for
- Ductus Arteriosus, Patent
- What is being tested?
- Rectal Solution and Intravenous Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2018to Jan 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn preterm neonates, < 1000 gm birth weight; < 28 weeks' gestational age; who are admitted to the neonatal intensive care unit of the Shaare Zedek Medical Center and are diagnosed with a hemodynamically significant patent ductus arteriosus within the first week of life and who are on limited or no enteral feeds -
Who cannot join
- Other congenital heart disease, major congenital anomalies, sepsis; and/or NEC.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Neonatal Intensive Care Unit - Shaare Zedek Medical Center
Jerusalem, 91031
About this study
Official title: Alternative Acetaminophen Treatment of the Hemodynamivally Significant Patent Ductus Arteriosus in Preterm Neonates Who Are Not Candidates for Enteral Administration: A Pilot Study
Early targeted treatment of a hemodynamically significant patent ductus arteriosus (hsPDA) during the first week of life in preterm neonates is often recommended. Our standard first line therapeutic approach is enteral acetaminophen. However many extremely low birth weight infants may be on limited or no feeds when PDA closure is determined to be indicated, thus restricting the use of enteral acetaminophen. Several studies have suggested that intravenous acetaminophen is less effective than enteral. Thus, in this study, we propose to compare two alternative modes of administration when enteral acetaminophen is not an option.
Read the detailed description
Once parental consent for entrance into the study is obtained, eligible babies will be randomized to receive either IV acetaminophen (perfalgen) by continuous infusion at 2.5 mg/kg/h following a loading dose of 15 mg /kg/ over 20 minutes or rectal acetaminophen at 15 mg/kg every 6 hours for a period of 3 days.
- Conditions
- Ductus Arteriosus, Patent
- Being tested
- Rectal Solution, Intravenous Infusion
- Keywords
- acetaminophen
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal SolutionDrug
Also called acetaminophen / paracetamol
Rectal acetaminophen at 15 mg/kg x 4/day for three days
Intravenous InfusionDrug
Also called acetaminophen / paracetamol
Loading dose of 15 mg/kg IV acetaminophen followed by a continuous infusion at a rate of 2.5 mg/kg/hr for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| Continuous IV Acetaminophen | Active comparator | Intravenous Infusion Receives: Drug: Intravenous Infusion |
| Rectal Acetaminophen | Active comparator | Rectal Solution Receives: Drug: Rectal Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ductal closure
Follow-up echocardiogram showing closed ductus arteriosus
Measured: Up to 1 week following treatment
Secondary outcomes (1)
PDA Ligation
Need for surgical ligation
Measured: Completion of study intervention until 40 weeks post-conception
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study startSep 2018 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductus Arteriosus, PatentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cathy Hammerman, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604796
- Sponsor's protocol ID
- 0207-18-SZMC
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Acetaminophen Treatment of the Hemodynamivally Significant Patent Ductus Arteriosus in Preterm Neonates Who Are Not Candidates for Enteral Administration: A Pilot Study
- ClinicalTrials.gov ID
- NCT03604796
- Acronym / sponsor ID
- 0207-18-SZMC
- Conditions
- Ductus Arteriosus, Patent
- Keywords
- acetaminophen
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early targeted treatment of a hemodynamically significant patent ductus arteriosus (hsPDA) during the first week of life in preterm neonates is often recommended. Our standard first line therapeutic approach is enteral acetaminophen. However many extremely low birth weight infants may be on limited or no feeds when PDA closure is determined to be indicated, thus restricting the use of enteral acetaminophen. Several studies have suggested that intravenous acetaminophen is less effective than enteral. Thus, in this study, we propose to compare two alternative modes of administration when enteral acetaminophen is not an option.
Detailed description
Once parental consent for entrance into the study is obtained, eligible babies will be randomized to receive either IV acetaminophen (perfalgen) by continuous infusion at 2.5 mg/kg/h following a loading dose of 15 mg /kg/ over 20 minutes or rectal acetaminophen at 15 mg/kg every 6 hours for a period of 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous IV Acetaminophen | Active comparator | Drug: Intravenous InfusionIntravenous Infusion |
| Rectal Acetaminophen | Active comparator | Drug: Rectal SolutionRectal Solution |
Who may qualify
- Ages
- 2 to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inborn preterm neonates, < 1000 gm birth weight; < 28 weeks' gestational age; who are admitted to the neonatal intensive care unit of the Shaare Zedek Medical Center and are diagnosed with a hemodynamically significant patent ductus arteriosus within the first week of life and who are on limited or no enteral feeds -
Key exclusion criteria (1 listed)
- Other congenital heart disease, major congenital anomalies, sepsis; and/or NEC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal SolutionAlso: acetaminophen / paracetamolRectal acetaminophen at 15 mg/kg x 4/day for three days | Drug | Rectal Acetaminophen |
| Intravenous InfusionAlso: acetaminophen / paracetamolLoading dose of 15 mg/kg IV acetaminophen followed by a continuous infusion at a rate of 2.5 mg/kg/hr for 72 hours | Drug | Continuous IV Acetaminophen |
Primary outcome
Ductal closure
Time frame: Up to 1 week following treatment
Follow-up echocardiogram showing closed ductus arteriosus
1 secondary outcome
PDA Ligation
Time frame: Completion of study intervention until 40 weeks post-conception
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy Hammerman, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rectal Solution and Intravenous Infusion in people with Ductus Arteriosus, Patent, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathy Hammerman, MD (0508685238, cathyh@ekmd.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ductal closure (time frame: Up to 1 week following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.