Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03549936 · ClinicalTrials.gov registry record · NA
Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome
A NA study of Neonatal Abstinence Syndrome, sponsored by MetroHealth Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT03549936 is a NA study of Neonatal Abstinence Syndrome that has completed, run by MetroHealth Medical Center. The registered enrollment target is 74 participants, above the 62-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (19% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03549936, a NA study of Neonatal Abstinence Syndrome, has completed, sponsored by MetroHealth Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study Summary
Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. There are no clinical studies to support this practice and it is currently unknown that low lactose formula really helps or not in management of NAS. This is a Randomized Double Blind Clinical Trial to assess the role of low lactose formula versus standard (regular) formula in managing NAS.
Conditions Studied
Interventions
- OTHER Low lactose or regular formula
Study Locations (1)
Ohio
- MetroHealth Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2014-07-09 |
| Est. Completion | 2018-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03549936
The ClinicalTrials.gov registry entry for NCT03549936 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 62-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (19% higher). The listed sponsor is MetroHealth Medical Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Low lactose or regular formula is the first listed.
NCT03549936 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03549936 about?
NCT03549936 is a clinical study titled "Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome". Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. There are no clinical studies to support this practice and it i...
What is the current status of trial NCT03549936?
This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2014-07-09. Estimated completion is 2018-06-30.
What conditions does trial NCT03549936 study?
This clinical trial studies the following conditions: Neonatal Abstinence Syndrome.
What interventions are being tested in trial NCT03549936?
The interventions under investigation include: Low lactose or regular formula (OTHER).
Who is sponsoring clinical trial NCT03549936?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03549936 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neonatal Abstinence Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
RECRUITING · NA
-
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
ACTIVE NOT RECRUITING · NA
-
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
ACTIVE NOT RECRUITING · NA
-
Neurostimulation to Improve NOWS Outcomes
ACTIVE NOT RECRUITING · NA
-
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
RECRUITING
-
Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
ACTIVE NOT RECRUITING · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.