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CompletedNCT03289390Updated Jan 13, 2020

Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

An observational study in Patent Ductus Arteriosus, sponsored by Albany Medical College. Completed at 1 site in United States. Open to participants aged 23 Weeks to 30 Weeks. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Albany Medical College · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11
Ages
23 Weeks to 30 Weeks
Sex
All
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Study summary

This study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational studies over a 3 year period. The first will be of infants with clinically significant PDAs beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a PDA closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our NICU, contraindication due to medical status.

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Conditions studied

  • Patent Ductus Arteriosus
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In context

Ductus Arteriosus, Patent

148 studies on the registry are indexed under Ductus Arteriosus, Patent; 18 are open to participants now.

This study's enrollment of 11 is below the median of 100 across 55 observational studies indexed under Ductus Arteriosus, Patent.

Browse Ductus Arteriosus, Patent studies →

Lead sponsor

Albany Medical College is the lead sponsor of 81 studies on the registry; 14 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
23 Weeks to 30 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Premature infants born between 23 0/7 weeks to 29 6/7 weeks gestational age.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Infants born at 23 0/7 to 29 6/7 weeks gestation, with PDA determined by medical team to need treatment and infant is beyond 14 days of life.

Exclusion criteria

Exclusion Criteria:

  • Congenital heart disease Pneumonia Pulmonary hypertension Pulmonary hemorrhage ALT and AST ≥ 2X the upper limit of normal (=AST> 150 U/L, ALT>90 U/L) Sepsis/meningitis Abnormal chromosomes Hydrops Major congenital malformations
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11 participants (actual)
Patient registry
No

Groups and cohorts

  • Acetaminophen to close PDA

    Infants with PDA treated with acetaminophen beyond 14 days of life or in whom acetaminophen is used due to contraindication to ibuprofen

    Drug: Acetaminophen

Interventions

  • DrugAcetaminophen

    Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.

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What researchers measure

Primary outcomes

  1. Rate of PDA closure

    PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.

    Time frame: 3 days

  2. Change in PDA size

    Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete.

    Time frame: 3 days

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Study locations

1 site
  • Albany Medical Center
    Albany, New York 12208, United States
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References and documents

Publications

  • El-Mashad AE, El-Mahdy H, El Amrousy D, Elgendy M. Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates. Eur J Pediatr. 2017 Feb;176(2):233-240. doi: 10.1007/s00431-016-2830-7. Epub 2016 Dec 21. PubMed 28004188 ↗
  • EL-Khuffash A, James AT, Cleary A, Semberova J, Franklin O, Miletin J. Late medical therapy of patent ductus arteriosus using intravenous paracetamol. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F253-6. doi: 10.1136/archdischild-2014-307930. Epub 2015 Feb 4. PubMed 25653299 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Jun 2019, 22 months.

Of 23 observational studies under Ductus Arteriosus, Patent, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 65. This study's 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2017
First posted
Sep 21, 2017
StartActual
Aug 1, 2017
Primary completionActual
Jun 30, 2019
CompletionActual
Jun 30, 2019
Last update
Jan 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03289390
Lead sponsor
Albany Medical College
Responsible party
Ronnelle King (MD, Albany Medical College) — Principal investigator
First posted
Sep 21, 2017
Start date
Aug 1, 2017
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Jan 13, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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