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: Completed NA study of Neonatal Abstinence Syndrome, sponsored by MetroHealth Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Every dose of morphine required to treat NAS over first 14 days of life will be noted and total cumulative dose administered will be observed. We expect infants on low lactose formula versus regular formula will require lower cumulative dose of morphine during first 2 weeks of life.
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 |
What the finished NCT03549936 record still lists
NCT03549936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 62-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (19% higher).
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 a single indexed study location in 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.
Where NCT03549936's enrollment target sits among peer trials
74 6th of 17 higher than 12 of 17 other Neonatal Abstinence Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neonatal Abstinence Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03422731 · 74 participants · Early Phase 1
Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy
- NCT03804853 · 74 participants · NA
Rehabilitation Following Reverse Total Shoulder Arthroplasty
- NCT04065776 · 74 participants · NA
Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma
- NCT04771156 · 74 participants · Phase 4
Ketorolac in Palatoplasty
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI