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NCT04298853 · ClinicalTrials.gov registry record · Phase 4

Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

A Phase 4 study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome, sponsored by Indiana University.

Completed
Registry status
Phase 4
Development phase
17
Enrollment target
1
Study location

NCT04298853 is a Phase 4 study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome that has completed, run by Indiana University. The registered enrollment target is 17 participants, below the 66-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04298853, a Phase 4 study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome, has completed, sponsored by Indiana University.

COMPLETED
Registry status
Phase 4
Development phase
17 participants
Enrollment target
1
Study location

Study Summary

Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.

Interventions

  • DRUG Morphine PRN
  • DRUG Morphine scheduled

Study Locations (1)

Indiana

  • Indiana University Health Methodist Hospital - Indianapolis

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2020-06-30
Est. Completion 2021-10-01
Phase Phase 4

Sponsor

Indiana University

890 total trials

What the Registry Record Tells You About NCT04298853

The ClinicalTrials.gov registry entry for NCT04298853 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 66-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (74% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Morphine PRN is the first listed.

NCT04298853 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT04298853 about?

NCT04298853 is a clinical study titled "Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome". Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.

What is the current status of trial NCT04298853?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2020-06-30. Estimated completion is 2021-10-01.

What conditions does trial NCT04298853 study?

This clinical trial studies the following conditions: Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome, Neonatal Opioid Withdrawal.

What interventions are being tested in trial NCT04298853?

The interventions under investigation include: Morphine PRN (DRUG), Morphine scheduled (DRUG).

Who is sponsoring clinical trial NCT04298853?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04298853 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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